Assessing the quality of life of patients in phase I and II anti-cancer drug trials: interviews versus questionnaires

Social Science & Medicine 56 (2003) 921–934

Assessing the quality of life of patients in phase I and IIanti-cancer drug trials: interviews versus questionnaires

Karen Cox*

Faculty of Medicine and Health Sciences, University of Nottingham, Medical School Room B50, Nottingham, UK

Abstract

This paper discusses two different approaches to assessing quality of life in the context of cancer clinical trial

participation. Drawing on empirical evidence from a study of patients’ experiences of phase I and II anti-cancer drug

trial participation, the paper demonstrates how different methods of collecting data about an individual’s quality of life

(questionnaires and interviews) can lead to alternative conclusions about patients’ trial experience and the impact of

trial involvement on their quality of life. Data obtained from the quality of life questionnaires interestingly revealed no

statistically significant differences in any of the scores over time while in-depth interviews uncovered something of the

psychological, emotional and social impact of taking part in a clinical trial from the perspective of the patient. The

paper concludes by reflecting on some of the methodological issues that arise when assessing the quality of life of

patients with a life threatening disease in clinical trials. r 2002 Elsevier Science Ltd. All rights reserved.

Keywords: UK; Cancer; Clinical trials; Quality of life

Defining quality of life

The concept of ‘quality of life’ was first introduced in

the 1960s and 70s, when surveys were undertaken in the

United States, to investigate the level of well-being of the

population (Campbell & Converse, 1976). As a concept

‘quality of life’ became part of the debate on the goals of

medical treatment in the late 1970s (De Haes & Van

Knippenberg, 1985). A now rapidly expanding literature

focuses on the evaluation of people’s quality of life as it

is affected by various disease states and treatments to

ameliorate or cure those diseases (Anderson, Bush, &

Berry, 1986; Berg, Hallauer, & Berk, 1976; Calman,

1984; Kaasa, 1992; Maguire & Selby, 1989; Moinpour,

Feigl, & Metch, 1989). The incorporation of this concept

into health care brings to the fore the issue that, not only

is the cure and survival of patients important, but their

well being must be considered as well. This argument is

of particular interest in cancer care where treatment is

often intrusive, uncomfortable and debilitating, not

always curative and, as a result, trade-offs have to be

made between the quality and length of life (Carey &

Burish, 1988; Maguire & Selby, 1989; Morrow, Lindke,

& Black, 1992). All these things can disrupt economic,

social, physical and psychological functioning and

frequently cause anxiety and depression, thus diminish-

ing quality of life (Fallowfield, 1990).

Quality of life is however a difficult concept to define

as cultural, ethical, religious and other personal values

influence perceptions and meanings of quality of life on

an individual basis (Calman, 1984; Cella & Tulskey,

1990; Gerson, 1976; Olschewski, Schulgen, Schumaher,

& Altman, 1984; Slevin, 1984; Zhan, 1992). The

theoretical framework of health-related quality of life

has therefore developed as a multidimensional perspec-

tive of health as a combination of physical, psycholo-

gical and social functioning. The break down of the

construct of quality of life into these domains has

formed the basis for the development of psychometric

tools to measure an individual’s quality of life (Aar-

onson, 1988; Fallowfield, 1990; Moinpour et al., 1989).*Tel.: +44-115-9709265; fax: +44-115-9709955.

E-mail address: [email protected] (K. Cox).

0277-9536/03/$ - see front matter r 2002 Elsevier Science Ltd. All rights reserved.

PII: S 0 2 7 7 - 9 5 3 6 ( 0 2 ) 0 0 1 0 0 - 4

Approaches to examining quality of life

An extensive number of tools are now available for

measuring health-related aspects of quality of life. Tools

are developed as either disease specific or generic

measures, through item selection, item reduction, pre-

testing and quantitative evaluation for reproducibility

and validity (see Bowling, 2001 for an extensive review

of these tools). Data is typically collected through the

use of forced-choice checklists and various scaling

devices that involve the individual in placing their own

assessment on a standardised form. Self-rating is

thought to be the most valid and reliable method for

measuring quality of life as previous research demon-

strates considerable variability in results between clin-

icians’ ratings of a patient’s quality of life, as compared

with patients’ own self-ratings on the same scale (Gill &

Feinstein, 1994; Pearlman & Uhlmann, 1988; Slevin,

Plant, Lynch, Drinkwater, & Gregory, 1988; Wilson,

Dowling, Abdolell, & Tannock, 2001).

Quality of life measures have evolved as quick, simple

questionnaires in response to the demands of a busy

clinic, with psychosocial endpoints being sought in the

same way as physiological endpoints. This approach,

however, has been criticised in the literature. For

example, Fitzpatrick (1995) asserts that although the

use of such instruments to measure quality of life has

potential benefits, including richer information about

subjects and the improvement of health-professionals’

awareness of the personal and social consequences of the

disease for their patients, there are difficulties associated

with their use. For example, instruments that appear to

cover similar dimensions of illness may, in reality, be

tapping important but different phenomena (Fitzpa-

trick, 1995). Thus a scale which purports to be

measuring psychological dimensions of an individual’s

experience of disease may in reality be measuring

something completely different to another scale which

uses similar terminology, according to how it is

interpreted by the individual completing the scale.

Numerical scores may reveal a problem but they may

not be specific or comprehensive enough to provide

information about what aspects of a person’s situation

need to be improved or the impact of a treatment on his

or her life (Fitzpatrick, 1995; Gill & Feinstein, 1994;

Lara-Munoz & Feinstein, 1999; Molin & Arrigo, 1995,

Padilla & Grant, 1985, Ringdal & Ringdal, 1993).

Further it has been argued that many quality of life

instruments reflect a purely physical perspective of

‘disease burden’ irrespective of the social context in

which the disease is experienced (Koch, 2000).

A prime question is whether these measures of quality

of life, designed to represent the functional or opera-

tional impact of care and treatment, are appropriate for

indicating what patients perceive as quality of life.

Phenomenologists in the field are arguing for a different

approach suggesting that quality of life depends on the

individual’s interpretation and perceptions (Ziller,

1974). Cohen (1982) points out that simply listing

quality of life domains is not a satisfactory way of

measuring quality of life as it is not known whether all

important domains have been included. Rosenberg

(1992) and Zahn (1992) have further argued that the

researcher-defined psychometric translation of quality of

life into components such as emotional, social and

physical does not capture the subjective nature of

individuals’ experiences.

Quality of life in cancer clinical trials

Despite the debates, health-related quality of life

assessment has received much attention in the arena of

cancer clinical trials. Quality of life data can provide

important information concerning the impact a treat-

ment is having on an individual. This information is

particularly useful in the context of clinical trials where

new treatments are being evaluated and compared with

standard treatment (Aaronson, 1992; Hopwood &

Thatcher, 1990; Kaasa, Bjordal, & Aaronson, 1995).

In the specific context of phase I and II clinical trials of a

new cytotoxic chemotherapy, where only one treatment

is being evaluated, quality of life is now being assessed in

terms of the impact of the treatment over time (Adams

& Bissett, 1993; Melink, Clark, & Von Hoff, 1992).

There have been a handful of researchers who have

adopted a more qualitative approach to assessing the

quality of life of patients with cancer (Bertero, Eriksson,

& Ek, 1997; Holmes, Coyle, & Thomson, 1997;

Montazeri, Milroy, Gillis, & McEwan, 1996) and those

participating in cancer clinical trials (Fox, 1959; Stetz,

1993). A common feature of these studies is the use of an

interpretative approach to explore individual percep-

tions of quality of life using in-depth interviews. Fox

(1959), in her work using ethnographic methods to

explore the social world of a metabolic research ward,

noted that the experimental nature of the treatments on

offer created situations of extreme stress in patients and

those caring for them, which in turn affected their

quality of life. Another (much later) American study

that attempted to assess the impact of trial involvement

on those participating, used in-depth interviews to

collect information from 24 patients who were under-

going experimental treatment (chemoembolisation) for

advanced cancer (Stetz, 1993). Following analysis of the

interview data, Stetz argued that the primary psychoso-

cial process that described the experience of patients

with advanced cancer receiving experimental therapy

was ‘survival work’. Through the use of a more

qualitative approach, both Fox (1959) and Stetz (1993)

highlighted the psychosocial impact that trial participa-

tion had on an individual and their quality of life, as

defined by the patients themselves.

K. Cox / Social Science & Medicine 56 (2003) 921–934922

Researchers in the field of quality of life research are

now suggesting that a combination of questionnaires

and interviews may be a more appropriate way of

exploring quality of life issues with patients (Cella &

Tulskey, 1990), but as yet there is little evidence of this

approach in the literature. This research therefore

provided an opportunity to gain some insight into how

useful such a combination might be. It would also

enable observation of the similarities and differences in

the picture of the impact of trial participation obtained

from using two different methods of data collection.

Ultimately the study would contribute to the methodo-

logical debate on the usefulness of these measures in

terms of assessing the quality of life of patients in this

situation, identifying any positive features and/or

problems with the approach.

Methods

In order to explore the impact of trial involvement

further and address the identified gaps in the literature, a

study was set up to examine patients’ own experiences of

trial participation and the impact on their quality of life

using a longitudinal prospective design. This study

concentrated on patients who were taking part in phase

I or II studies where the drug is at an early stage of

testing and the potential benefits or harm are unknown

and the patients themselves have advanced terminal

disease. Permission to undertake the study was obtained

from the Local Research Ethics Committee.

Participants were recruited from a regional cancer

centre with a dedicated trial team, over a one-year

period. Patients (n ¼ 83) who had been offered partici-

pation in one of the phase I or II anti-cancer drug trials

running in the cancer centre were provided with written

information about the study by their trials nurse. If they

were willing to take part, the researcher then ap-

proached them and their consent was obtained to take

part in the study.

Fifty-five patients consented to be interviewed (and

filled in 2 quality of life questionnaires) about their trial

experience (22 men and 33 women) The median age was

60 years with a range of 37–74 years. Over 70% of the

patients were married. The majority of the tumour sites

were the common solid tumours, lung, breast and

gastrointestinal. Forty percent of the patients had not

received any treatment for their disease prior to the offer

of the trial treatment, reflecting the fact that this group

of patients had disease at sites where there is no standard

treatment or where current effective treatments are

limited. In addition the majority of patients had been

diagnosed for less than 12 months.

Data collection

Information was collected from patients through the

use of in-depth interviews at four points in the trial

experience: pre-trial (as soon as possible after the

decision had been made to participate in the trial),

during the trial (normally after 2 cycles of treatment

approx. 6 weeks), at trial conclusion and 6–8 weeks

follow-up. Patients were interviewed in their own homes

or in a quiet room in the cancer centre. The interviews

began with patients completing the quality of life

questionnaires, two previously validated quality of life

measures, commonly used in cancer clinical trials. The

measures chosen were the European Organisation for

Research and Treatment of Cancer (EORTC) QLQ-C30

quality of life questionnaire (Aaronson, Ahmedzai,

Begman, & Cull, 1993) and the Hospital Anxiety and

Depression Scale (HADS) (Zigmond & Snaith, 1983).

The EORTC questionnaire has been previously vali-

dated for use in cancer patients with various diagnoses

(Kaasa et al., 1995; Ringdal & Ringdal, 1993). The

HAD scale has been previously validated and used

successfully in populations of cancer patients (Clark &

Fallowfield, 1986) and is reported as being acceptable to

patients (Cody, Nichols, Brennan, Armes, & Slevin,

1993).

Once the forms were completed patients were asked to

talk about their trial experiences to date. Interviews

consisted of open questions focused on recruitment,

information disclosure, understanding, decision-making,

reasons for trial participation or otherwise, experience of

trial involvement, support needed, follow up care,

impact on quality of life, the meaning of trial participa-

tion and satisfaction with care received.

On completion of the interview patients were asked if

they would consent to further interviews as they

progressed through the trial. All 55 patients had a pre-

trial interview. Thirty-five patients had a during trial

interview, 5 had died, 2 refused and 13 had been

withdrawn from the trial and so for these 13 this

interview was omitted and they went straight to a post-

trial interview. Thirty-seven patients had a post-trial

interview, 12 patients were now dead and 6 refused to be

interviewed. At follow-up 27 patients were interviewed,

21 were now dead and 7 refused to be interviewed. In

total 154 interviews were carried out and 306 ques-

tionnaires were completed, 20 patients had data

collected by interview and questionnaires at all four

time points.

Method of analysis

This combination of qualitative and quantitative

methods in a single study raised challenges not only

methodologically but also in terms of criteria for

assessing reliability and validity and the way the

research findings were written up. There are few

guidelines for researchers who wish to utilise mixed

methods in their work. This leaves the researcher asking

numerous questions about how to combine numerical,

linguistic and textual data, how to interpret divergent

K. Cox / Social Science & Medicine 56 (2003) 921–934 923

results between numerical and linguistic data, how to

present the findings in a research report and how to

ensure the credibility, dependability, confirmability and

transferability of the findings. In this study a decision

was made to provide systematic and explicit descriptions

of the research process and data analysis procedures and

to analyse and present each type of data separately,

according to the principles of analysis relevant to the

type of data. This was followed with a search for

patterns of relationship and meanings between and

among both types of data using case studies of

individual patients.

Data obtained from the interviews was analysed using

an inductive approach to generate categories, patterns

and themes from the data. The approach selected was

the use of the constant comparative method described

by Strauss & Corbin (1990). Data analysis was aided by

the use of the qualitative data analysis package

NUD.IST. Following the fine coding of the interviews

related codes were grouped together into sub-categories

and then as core categories providing meaningful units

of data. This ‘pattern coding’ (Miles & Huberman, 1994)

begins the process of moving from data description to

data interpretation. The development and conceptuali-

sation of three major themes emerged through identify-

ing relationships and connections between and within

the core categories. These three themes appeared to

capture the primary psychosocial issue patients were

having to deal with at particular points during their trial

involvement.

The data from the EORTC QLQ C-30 and the HADS

questionnaires were analysed with the aid of the

statistical software package SPSS for Windows. The

HADS questionnaire assigns a number between 0 and 3

to each question answered by the respondent. These

scores are summed for each of the two sub-scales of

anxiety and depression and a score is ascertained for

each scale. The EORTC QLQ C-30 is designed to enable

the researcher to calculate a score for each of the five

functional scales and nine symptom and item scales

assessed by the questionnaire as well as producing an

overall global quality of life score.

Following this separate analysis the quantitative and

qualitative data were compared and contrasted through

case studies of individual trial experiences. The aim was

to assess the relationship between the impact of trial

participation as portrayed by questionnaire data and the

same impact as revealed through in-depth interviews.

Findings

Common themes recurred throughout the interview

material and it is clear that trial participants shared

much in common no matter what their age, sex, disease

site or the particular drug they were receiving. These

themes have been labelled, ‘therapeutic alliance’, ‘trial

burden’ and ‘searching for meaning’ to describe the way

these patients’ accepted trial participation, dealt with the

trial treatment and came to terms with trial conclusion.

Each theme is made up of categories of data that

illustrate patients’ information, decision-making and

support needs throughout trial involvement as well as

the impact of trial participation on their lives. These

themes have been described in greater detail elsewhere

(see Cox, 1999, 2000) and so are briefly presented here.

The first theme, therapeutic alliance, refers to a

process that occurred during trial recruitment whereby

patients actively chose to ally themselves with the

investigators who were offering trial treatments and

therefore hope. By allying themselves in this way it

appeared individuals felt more in control of what was

happening to them and gained a sense of self-worth at a

time when they thought that there was nothing else that

could be done for them. Their reasons for accepting trial

participation and the influences on their decision-

making all reflect this theme.

The second theme, trial burden, reflects patients’

experiences of trial involvement and highlights some of

the unanticipated consequences of clinical trial partici-

pation. The burden of trial participation was identified

to be both a physical and emotional one. The side effects

of treatment, additional demands of trial participation

in terms of personal time, travel, waiting and extra tests

all contributed to this burden, which was compounded

by uncertainty of outcome. Increasingly, patients talked

about weighing up the harm versus the benefits of the

trial treatment and, as time progressed, the strong belief

that participation was worthwhile was overtaken by a

sense of disillusionment and a feeling that they had ‘had

enough’. Dealing with these physical and emotional

burdens often led patients to question why they were

putting themselves through the trial in the first place and

whether it was all worthwhile. Trial participation

demanded an investment of time, emotional and

physical energy from patients and families that meant

other aspects of their lives were effectively put on hold

for the duration of their trial involvement.

Finally the third theme, searching for meaning, refers

to the process patients appeared to engage in at trial

conclusion whereby they actively construct some posi-

tive meaning out of trial participation. This theme

reflects the disappointment many patients described on

concluding the trial due to the lack of tumour response

they had experienced in relation to the trial burden they

had endured. At this time patients were also full of

uncertainty about what the future now held for them,

felt abandoned by trials staff and in some cases were

questioning whether they had been used merely as a

means to an end by those running the trials. Yet, despite

such serious concerns, the majority of patients in this

study nevertheless indicated that they would make the


same decision to participate in a similar trial if it was

offered to them and hoped that they had helped others

by their participation. They remained interested in the

trial they had taken part in, and frequently requested

feedback about the trial outcome and whether the trial

had been a worthwhile thing to be involved in.

Based on this interview data the impact of trial

involvement on patients’ lives was both positive and

negative. Positive aspects of participation included being

offered the chance to participate in something that was

perceived to be of benefit, hope, generating a sense of

purpose in life and the feeling of contributing to

something worthwhile. Negative aspects included having

to deal with uncertainty, the emotional and physical

impact of trial treatment and trial conclusion and having

to find some other meaning for having taken part in a

trial that did not necessarily benefit them.

The impact of trial participation on quality of life

Results from analysis of the EORTC questionnaire

are presented first, followed by results from the HADS

questionnaire. Table 1 below presents the EORTC

scores at the four data collection points.

Score distributions were roughly symmetrical for the

majority of the functioning scales. The two exceptions

were the cognitive and the emotional functioning scales,

which exhibited a negative skew (in that more patients

scored towards maximum functioning). The cognitive

results were similar to those reported by Aaronson et al.

(1993). The symptom scales and single item measures

were generally well distributed with the exception of

financial, diarrhoea, pain and sleep which were all

positively skewed, indicating that they were less of a

problem. Scores for nausea and vomiting were positively

skewed (less problematic) with the exception of time

point three (trial conclusion) where there is a more

symmetrical distribution. Similarly those symptoms

associated with cancer and its treatment were reported

more frequently, i.e. fatigue and lack of appetite.

Table 2 presents the HADS mean scores and standard

deviations for anxiety and depression at the four data

collection points.

Both the anxiety and depression scales demonstrated

a negative skew (i.e. more patients scoring toward lower

levels of anxiety and depression). The scores for both

anxiety and depression for these patients over the course

of trial participation were within the normal range (0–7)

(Zigmond & Snaith, 1983). However the HADS ques-

tionnaire, unlike the EORTC QLQ C-30, does have

established descriptors for the obtained scores. Table 3

presents the distribution of anxiety and depression

scores over the four categories: normal, mild, moderate

and severe. These findings suggest that at each stage of

trial involvement only a small number of patients were

experiencing severe psychological distress which would

Table 1

EORTC descriptive statistics for all patients

Pre-trial n ¼ 54* During trial n ¼ 35 Post-trial n ¼ 37 Follow up n ¼ 27

Mean SD Median Mean SD Median Mean SD Median Mean SD Median

Functional scales**

Physical 52.59 27.82 50.00 62.28 25.56 60.00 57.83 24.39 60.00 62.22 25.01 60.00

Role 44.44 33.49 50.00 50.47 33.2 50.00 43.24 28.18 33.33 47.53 31.59 50.00

Cognitive 75.30 22.83 83.33 79.52 18.99 83.33 81.98 16.37 83.33 80.24 23.12 83.33

Emotional 63.42 27.63 66.66 74.52 21.57 75.00 69.36 25.53 75.00 74.69 27.39 83.33

Social 54.32 33.98 66.66 51.42 29.53 66.66 52.25 26.69 50.00 62.34 31.88 66.66

Global QOL 50.00 24.01 50.00 54.52 18.67 58.33 47.74 21.84 50.00 55.86 25.92 66.66

Symptom and/or item scale***

Fatigue 56.58 25.01 55.55 49.84 25.61 44.44 55.25 25.04 55.55 51.85 28.41 55.55

Nausea and vomiting 17.28 23.33 00.00 20.47 26.22 16.66 30.63 30.3 33.33 17.28 25.93 00.00

Pain 36.72 30.77 33.33 23.8 28.37 16.66 27.02 28.69 16.66 22.22 18.49 16.66

Dyspnoea 38.27 35.7 33.33 33.33 32.33 33.33 42.34 37.39 33.33 33.33 35.8 33.33

Sleep 41.97 35.57 33.33 25.71 28.1 33.33 33.33 32.39 33.33 29.62 32.46 33.33

Appetite 51.23 37.59 33.33 35.23 35.18 33.33 46.84 35.53 33.33 39.50 39.26 33.33

Constipation 32.09 35.44 33.33 15.23 20.36 00.00 23.42 32.26 00.00 28.39 31.62 33.33

Diarrhoea 14.19 25.57 00.00 19.04 25.92 00.00 14.41 25.5 00.00 6.17 16.11 00.00

Financial 10.49 20.29 00.00 9.52 19.08 00.00 10.81 17.66 00.00 8.64 19.81 00.00

*One patient refused to fill in any questionnaires from the total sample of 55.

**Scores range from 0 to 100. Higher scores represent a higher level of functioning.

***Scores range from 0 to 100. Higher scores represent a greater degree of symptoms.


warrant some kind of intervention (scores over 14) with

anxiety being more prevalent for this group than

depression. It is also interesting to note that these

prevalence rates were lower than the suggested 17–20%

reported by other research teams (Derogatis, Morrow, &

Fetting, 1983; Ibbotson, Maguire, Selby, Priestman, &

Wallace, 1994).

These questionnaires present a picture of the impact

of trial participation at the level of physical, role,

cognitive, emotional and social functioning. They

suggest which symptoms were causing most problems,

and they provide insight into the levels of anxiety and

depression experienced by these patients. They also seem

to suggest that for the patients in this study, physical

problems outweighed emotional ones. One possible

explanation is that while patients had a progressing

disease with physical repercussions, participation in a

trial helped them to remain positive about their

situation. However, this is difficult to claim due to the

lack of a control group in this study and it may be that

other factors such as social support, increased attention

and a range of other resources kept the patients

functioning well emotionally. From the questionnaire

results it is difficult to ascertain the impact of trial

participation on these patients’ quality of life, not least

because the means of the various scales and items

appears to suggest few changes over time. It must be

acknowledged, however, that at each data collection

point the sample differs as not all patients were followed

up at every point, making the comparison of means

across time inappropriate. Even when considering the

patients for whom data was collected at all four points

(n ¼ 20) there was no significant change in the scores

over time when subjected to repeated measures analysis.

This could of course, reflect bias due to self selection if

patients who were not coping well dropped out of the

trial or refused to be interviewed.

Comparing interview and questionnaire data

The following section (case studies followed by

discussion) compares interview data with questionnaire

data and considers the insight each method of data

collection provides into patients’ quality of life over the

course of trial participation. This comparison provides

an opportunity to assess the meaning and usefulness of

the obtained quality of life scores at an individual level

through an examination of associated interview data. As

such it reveals issues that contribute to the methodolo-

gical debate surrounding the assessment of quality of

life.

Case study 1—Mrs. X

Mrs. X, a 52-year-old woman, was first diagnosed

with breast cancer in 1985. At the time of her diagnosis

Mrs. X had a mastectomy followed by radiotherapy and

then a course of Tamoxifen. She had remained well until

the summer of 1994 when she experienced abdominal

pain and altered bowel habits. A subsequent bone and

CT scan indicated metastases in her cervical spine and

liver. It was at this time that Mrs. X was offered a phase

II trial of a new combination of drugs for breast cancer.

Table 2

HADS mean scores for all patients

Pre-trial n ¼ 54 During-trial n ¼ 35 Post-trial n ¼ 37 Follow-up n ¼ 27

Mean SD Median Mean SD Median Mean SD Median Mean SD Median

Anxiety 7.7 4.13 7.50 6.37 3.79 6.00 6.59 4.27 7.00 6.48 4.37 6.00

Depression 6.25 3.29 7.00 5.88 3.63 5.00 6.05 3.58 6.00 5.33 3.6 5.00

Scores range from 0 to 21. Higher scores represent higher levels of anxiety or depression.

Table 3

Interpretation of HADS scores for anxiety and depression and percentage of patients in each category

SCORE Anxiety/depression level Pre-trial (n ¼ 54) Dur. trial (n ¼ 35) Post-trial (n ¼ 37) Follow-up (n ¼ 27)

Anxiety Depression Anxiety Depression Anxiety Depression Anxiety Depression

0–7 Normal 27(50%) 35(65%) 24 (68%) 25(72%) 23 (62%) 26(70%) 17(63%) 22(81%)

8–10 Mild 16(30%) 13(24%) 7 (20%) 5(14%) 8 (22%) 7(19%) 6 (22%) 3(11%)

11–14 Moderate 7(13%) 6(11%) 2 (6%) 5(14%) 3 (8%) 3(8%) 3 (11%) 1(4%)

15–21 Severe 4(7%) None 2 (6%) None 3 (8%) 1(3%) 1 (4%) 1(4%)


At the beginning of trial treatment Mrs. X described

feeling ‘tired’, and ‘slowed down’, she was losing weight,

had diarrhoea and was not enjoying her food. She had

taken sick leave from work and her social life was also

curtailed, as she felt so tired. At this time Mrs. X

described how she and her family were all pinning their

hopes on this new treatment and that she felt positive

about what was happening.

Over the following 2 months Mrs. X received two

cycles of the trial treatment. During her second interview

Mrs. X described feeling tired, achy, not interested in

food, and ‘generally grotty’ for about a week after her

treatment. Her social activities remained curtailed; she

was still not making any plans and described being

asleep on the sofa by midday. On the positive side she

described how being in the trial made her feel special, as

she received more attention than in a normal clinical

situation and the staff seemed to have more time. Mrs. X

continued on to have her third and fourth cycles of

treatment. The third treatment made her feel very ill and

she described almost giving up, she experienced a period

of hospitalisation for neutropenia and for insertion of a

hickman line. Mrs. X had all six cycles of the trial

treatment, and following completion of the trial she had

a CT scan that revealed stable disease.

During the third interview (on completion of trial

treatment) Mrs. X expressed obvious disappointment at

her lack of response. She described feeling tired, had

diarrhoea, was unsure what was going to happen next

and felt abandoned by the team at the unit. Eight weeks

after completing trial treatment Mrs. X was losing

weight, experiencing pain at night which was preventing

her from sleeping and she generally felt unwell. She

described wanting information about the outcome of the

trial, feedback on the other patients who had also

participated and whether it had been a worthwhile thing

to be involved in. Overall she described her quality of

life as poor, she felt as if she was relying on others all the

time and was uncertain about her own future. The trial

experience for Mrs. X described above was ascertained

through in-depth interviews. Below are her scores from

the quality of life questionnaires (Table 4).

The scores and visual changes observed in this case do

reflect something of the impact of trial participation on

Mrs. X as ascertained through her verbal descriptions of

the trial experience. The general deterioration in

physical, role and social functioning she describes

throughout trial participation is reflected in the decreas-

ing scores on those scales. The impact of trial with-

drawal and how she felt on realising the trial treatment

had not met her initial expectations is also reflected in

the decrease again in scores for emotional and social

functioning. The overall trend was one of a general

deterioration in functioning on all the scales that

Table 4

EORTC and HAD scores for case study 1

Pre-trial During trial Post-trial Follow-up

Functional scales*

Physical 80.00 60.00 60.00 60.00

Role 66.67 33.33 33.33 50.00

Cognitive 83.33 83.33 66.67 100.00

Emotional 100.00 100.00 83.33 91.67

Social 83.33 66.67 50.00 66.67

Global QOL 66.67 41.67 41.67 41.67

Symptom and/or item scale**

Fatigue 33.33 55.56 77.78 55.56

Nausea/vomiting 00.00 00.00 16.67 16.67

Pain 33.33 16.67 16.67 16.67

Dyspnoea 00.00 33.33 33.33 00.00

Sleep 00.00 00.00 33.33 33.33

Appetite 66.67 66.67 66.67 66.67

Constipation 00.00 00.00 00.00 33.33

Diarrhoea 33.33 67.67 67.67 67.67

Financial 00.00 00.00 00.00 00.00

HAD scale***

Anxiety 3 1 3 5

Depression 2 4 4 5

*Scores range from 0 to 100. Higher scores represent a higher level of functioning.

** Scores range from 0 to 100. Higher scores represent a greater degree of symptoms.

*** Scores range from 0 to 21. Higher the score the more severe the anxiety or depression.


probably also reflects her general deterioration as her

disease progressed. The slight improvement in the scores

at follow-up may be more to do with stopping the toxic

chemotherapy treatment rather than any significant

improvement in her medical condition.

The scores obtained on the symptom scale of the

EORTC questionnaire indicate that at the beginning of

trial treatment the symptom causing Mrs. X most

problems was loss of appetite (score=66.67). This high

score reflects the way Mrs. X also spoke about having

difficulty eating and problems with weight loss. Other

problems she identified pre-trial treatment were diar-

rhoea, fatigue and pain, although these scores were in

practice rather low at just over 30. In the meanwhile her

problem of lack of appetite remained high but relatively

stable throughout trial participation. Fatigue, however,

increased throughout trial participation and was at its

highest at trial conclusion (score=77.78) reflecting the

fact Mrs. X had just completed six cycles of very

demanding treatment. Her diarrhoea worsened as she

progressed through the trial and it did not improve on

trial conclusion or follow-up. In general the scores on

the symptom scales indicate that trial treatment or

disease progression was having an effect on Mrs. X in

terms of increasing fatigue, diarrhoea and sleep pro-

blems. In this respect the questionnaire data presented a

picture similar to that ascertained through the interview

data.

Scores for anxiety and depression throughout trial

involvement remained within the normal range. There

was however a general trend for the scores on both these

scales to increase throughout trial participation and

follow-up. This corresponds with the high score for

emotional functioning on the EORTC questionnaire.

However, the fact that the scores are within the normal

range reflects nothing of the problems and anxieties

Mrs. X was expressing during her interviews where she

talked about the tensions with her family, her un-

certainty about the benefit of the treatment, and her

disappointment that it was not working for her.

Case study 2—Mr. Y

Mr. Y was a 60-year-old man, who lived alone, had

never been married, worked in a local factory and was

currently on sick leave. Mr. Y was diagnosed with

cancer of the colon in November 1995 and had surgery

to remove the tumour. However, in December 1996 he

was experiencing a tightness in his abdomen and had

another scan which revealed progressing disease. It was

after this that he was given an information sheet about

an experimental phase I trial drug. His main hopes at

this point were to stop the cancer spreading and he

stated he would do anything not to die. Throughout this

first interview Mr. Y described how he was trying to get

on with his normal life but that sometimes it took a lot

of effort. He was frightened by the pain he was

experiencing and was concerned about his job and

whether or not to take early retirement.

Mr. Y remained incredibly anxious throughout his

trial participation. After two cycles of the trial treatment

he attended for a review of his treatment. At this stage

Mr. Y described feeling tired, falling asleep during the

day and yet having difficulty sleeping at night. He was

constantly uncertain about how well he was responding

to the treatment and if it was working. Mr. Y received

three cycles of the trial treatment in total and was then

withdrawn by the doctor from the trial due to the fact

his disease was progressing. Mr. Y described himself as

being shocked and devastated that he could no longer

continue with the trial treatment. He described how he

felt this was the end of the road and that the doctors had

given up on him. His biggest concern at this point was to

know what was going to happen next as he felt in limbo.

Mr. Y was still trying to make the effort to socialise and

remain independent in his own home. His biggest

problems were now worry and tiredness.

Seven weeks later at the follow up interview, Mr. Y

was anxious and upset, he had begun to feel nauseated,

had a lack of appetite and was experiencing abdominal

pain. Mr. Y described his quality of life as very poor due

to the fact that he was worrying all the time about what

the future held for him and was unable to sleep. The

data below presents the scores from the quality of life

questionnaires that were administered at the same time

as Mr. Y was interviewed (Table 5).

The scores obtained on the areas of functioning

assessed using the questionnaire do appear to reflect

something of the impact of trial participation described

in the interviews by Mr. Y. The overall trend for scores

to increase once he had started treatment appeared to

reflect the positive impact of trial involvement and the

feeling he was doing something to help himself.

Examples include his scores for emotional functioning,

global quality of life and role functioning, which all

improved once he had started trial treatment. Social

functioning was, however, scored as decreasing which

might be explained by the fact that Mr. Y was having to

attend the unit frequently and was experiencing fatigue

from his treatment. The deterioration in all the scores at

trial withdrawal and follow-up appear to reflect the

disappointment and anxiety he described in his inter-

views when he discussed his experience on being told his

disease was progressing and that there was no other

treatment available.

According to the scores obtained on the symptom

scales on the questionnaires, Mr. Y’s biggest problem at

the beginning of trial treatment was difficulty with

sleeping (score=100). Other symptoms reported in-

cluded lack of appetite, fatigue, nausea and pain,

although all these were rated towards the bottom of

the scale apparently indicating that he regarded these as

causing little problem. Scores on all the scales remain


low until follow-up when they increase dramatically,

especially problems with appetite and fatigue. Scores on

the sleep scale indicate a dramatic improvement at the

time of trial conclusion, which corresponds with the fact

that Mr. Y had been taking sleeping tablets. However at

follow-up the problem increased again to the very high

score obtained at the beginning of the trial.

The scores on Mr. Y’s symptom scales over the course

of trial participation showed a general increase in

symptoms at trial follow-up. This trend probably

indicates something of Mr. Y’s progressing disease,

rather than the impact of the trial drug. The interviews

reveal that his main symptoms were pain, tiredness and

a lack of appetite and these are picked up on the scales.

The scores on the HADS scale for anxiety were within

the severe range and appeared to correlate with the high

levels of anxiety Mr. Y expressed during his interviews.

The scores obtained on the depression scale were in the

normal range and remained stable over the course of

trial participation. The HADS in this case appeared to

be able to detect the quite disabling anxiety this

gentleman experienced.

Case study 3—Mrs. Z

Mrs. Z, a divorced 60-year-old woman was diagnosed

with ovarian cancer in October 1994. Surgery revealed

an inoperable ovarian cancer and this was followed by a

course of chemotherapy. Within 18 months she was

experiencing symptoms again and received further

chemotherapy, and 3 months later she was ‘going

downhill’ again. It was at this point that her consultant

offered her the chance to take part in a phase I trial of a

new cytotoxic chemotherapy which was being tested in

ovarian cancer. Mrs Z described how she felt that she

would try anything as she had little left to lose, as well as

the hope that it might be a wonder drug or that it could

improve her quality of life. She described her quality of

life at the beginning of the trial as ‘very poor’ as she was

feeling ‘lousy’ and wanted to get back to normal and

enjoy her social life again. Over the following 2 months

Mrs. Z received two cycles of the trial treatment. When

the time came to have the third treatment, however, she

refused saying that she was frightened by how the

treatment made her feel and that she couldn’t face any

more. Mrs. Z had experienced nausea and fatigue, was

unable to sleep, lost energy, became breathless and spent

much of the day in bed. Seven weeks later during her

follow-up interview Mrs. Z described herself as feeling

physically much better although feeling uncertain still as

to her future, due to the fact she felt her disease was

progressing again. During the final interview Mrs. Z

described her quality of life as being ‘poor’, and she said

Table 5


Pre-trial Post-trial During trial Follow-up

Functional scales*

Physical 100.00 100.00 100.00 80.00

Role 83.33 100.00 83.33 33.33

Cognitive 83.33 83.33 83.33 67.67

Emotional 25.00 41.67 16.67 00.00

Social 83.33 66.67 66.67 66.67

Global QOL 50.00 58.33 50.00 22.22

Symptom and /or item scale**

Fatigue 22.22 33.33 33.33 55.56

Nausea and vomiting 16.67 16.67 16.67 33.33

Pain 16.67 00.00 00.00 16.67

Dyspnoea 33.33 00.00 00.00 00.00

Sleep 100.00 66.67 00.00 100.00

Appetite 33.33 00.00 00.00 66.67

Constipation 33.33 00.00 00.00 33.33

Diarrhoea 00.00 00.00 00.00 00.00

Financial 00.00 33.33 33.33 00.00

HAD scores***

Anxiety 15 16 15 19

Depression 7 5 6 6



*** Scores range from 0 to 21. Higher the score the more severe the anxiety or depression.


she deeply missed her independence, social life and being

able to sleep peacefully. Contact with the oncology unit

was now on a monthly basis. The data below presents

the scores from quality of life questionnaires that were

administered at the same time as Mrs. Z was interviewed

(Table 6).

The scores and visual changes observed in this case do

reflect something of the impact of trial participation on

Mrs. Z as ascertained through her verbal descriptions of

the trial experience. Physical, social and role functioning

were all identified as being areas of her life where she

was experiencing problems and this is reflected in her

poor scores at the beginning of trial treatment. The

general improvement in scores on trial conclusion and

follow-up may reflect some of the relief she felt on

stopping the trial and her gradually improving physical

status, which was observed at the follow-up interview.

The one significant mis-match between the interview and

the questionnaire data appears to be the scores obtained

on the emotional functioning scale; questionnaire scores

indicate a high level of functioning throughout trial

involvement and yet in interviews Mrs. Z often described

herself as feeling ‘uncertain’ and ‘worried’ about her

current state of health and her future. The scores she

obtained for anxiety and depression on the HADS

questionnaire appear to more accurately reflect this

aspect of her quality of life.

The scores obtained on the symptom scales of the

EORTC questionnaire indicate that Mrs. Z was

experiencing a high degree of fatigue, loss of appetite

and lack of sleep at the beginning of trial treatment. The

problem with fatigue remained high yet scores for

problems with appetite and sleep appeared to improve

at trial conclusion and follow up. Scores for constipa-

tion, diarrhoea and financial problems suggest Mrs. Z

regarded these as negligible difficulties. The problem

Mrs. Z talked about in relation to shortness of breath is

picked up by the high score obtained at trial conclusion

on the scale for problems with dyspnoea. The scores

obtained for problems with nausea and vomiting also

reflect the improvement in this symptom on trial

conclusion and follow up. The problem in interpreting

the scores in this case is that Mrs. Z was experiencing

many of her symptoms prior to the administration of

chemotherapy and describes herself as being ‘pretty

poorly’. In addition any improvement in the scores is

difficult to interpret as scores for symptoms experienced

during the trial are not available as Mrs. Z was not

interviewed during the trial, only with reference to the

interview data can we establish that the problems of

nausea, fatigue and lack of appetite were on-going

during the administration of the trial treatment. How-

ever the scores obtained on the questionnaires and the

interview data do indicate Mrs. Z felt her physical

Table 6


Pre-trial During trial Post-trial Follow-up

Functional scales* No interview

Physical 20.00 20.00 60.00

Role 00.00 00.00 16.67

Cognitive 33.33 66.67 50.00

Emotional 83.33 83.33 91.67

Social 00.00 16.67 16.67

Global QOL 00.00 33.33 33.33

Symptom and /or item scale**

Fatigue 100.00 88.89 77.78

Nausea and vomiting 50.00 33.33 00.00

Pain 16.67 00.00 33.33

Dyspnoea 00.00 66.67 00.00

Sleep 66.67 00.00 00.00

Appetite 100.00 33.33 33.33

Constipation 00.00 00.00 33.33

Diarrhoea 00.00 00.00 00.00

Financial 00.00 00.00 00.00

HAD scores***

Anxiety 5 1 10

Depression 12 10 8



*** Scores range from 0 to21. Higher the score the more severe the anxiety or depression.


condition had improved at the time of her follow-up

interview.

In summary these case studies attempted to compare

the picture of an individual’s quality of life drawn from

their own descriptions of the trial experience with

information obtained using quality of life question-

naires. In these three case studies there was often an

association between the interview material and the

questionnaire data; numerical scores commonly reflected

something of the trial experience described by the

patient. Due to the constraints of space only three case

studies are presented here and it is recognised, therefore,

that it would be unsatisfactory to draw definitive general

conclusions about relationships between the interview

and questionnaire data in all other cases. However these

cases and examination of the other cases did suggest that

the questionnaire data often indicated trends which

could be further explained by associated interview

material. Yet, at the same time, there was also a

considerable degree of tension between the two sources

of data, an issue that is considered further in the

following section.

Discussion

Considered alone, the numerical data produced by the

two quality of life questionnaires used in this study

could easily give the impression that trial participation

had a negligible impact on patients’ quality of life when

considered at a group level. Of course the small sample

size may well have been a significant contributory factor

making it difficult to identify any statistically significant

change. Furthermore, means that stay the same can

mask increases and decreases at an individual level.

However this was not the sole, or even the determining

factor, as earlier studies using quality of life question-

naires to study change in quality of life over time, using

the same repeated measures tests applied in this study,

also found that trial participation apparently had no

impact on patients’ quality of life (Melink et al., 1992;

Adams & Bissett, 1993). Even in studies with larger data

sets repeated measures ANOVA failed to detect any

significant change in scores over time (pre-treatment to

on-treatment) with the use of the total patient sample on

the functional scales or six of the seven symptom scales

(the exception being nausea and vomiting) until they

tested for between group differences on the basis of

performance status (see Aaronson et al., 1993). Yet as

can be seen from the picture of trial participation

portrayed by the interview data, taking part in a clinical

trial evidently did affect patients’ lives and the quality of

their lives in varied and often profound ways. So it

seems that the problem with quality of life question-

naires is not only one of obtaining statistical signifi-

cance. Rather the problems seem to have been that while

the scores indicated a particular trend, they were

relatively meaningless to the researcher and the patients

involved and required further contextual and descriptive

information in order to interpret and explain them.

Because of this problem, the tools alone appear to offer

little understanding of the impact of trial participation

on the quality of patients’ lives in this study.

The interview material was combined with the

numerical data by making case studies of patients,

comparing the trial experience portrayed by each type of

data and then identifying the similarities and differences

between them. However comparing the two types of

data at an individual level and for the group was far

from a straightforward matter. One problem that

occurred was that the numerical score obtained for a

particular issue or problem did not appear to reflect the

magnitude of the problem as described by patients

during their interview. The patients seemed to be

minimising their problems on the quality of life

assessment forms. For example, nausea and vomiting

was the second most common side effect mentioned in

interviews during trial participation (20 out of 35

patients). However on the EORTC QLQ-C30 nausea

and vomiting scale the mean score was 20 for the group

as a whole (scores range from 0 to 100, higher scores

reflect a greater problem). If we considered the group

score alone we would assume that nausea and vomiting

was a problem only of moderate magnitude for this

group of patients. However, the number of patients who

mentioned being sick or feeling sick during their

interviews, and the way they describe it leads to different

conclusions.

Another example where the questionnaire data did

not reflect the magnitude of the problem as described by

patients in an interview is in relation to the scores

obtained for anxiety and depression. As with nausea and

vomiting if we consider the scores alone we would

conclude that the majority of patients in this study were

experiencing little in the way of emotional difficulty. Yet

patients’ descriptions of the emotional burden of trial

participation and the devastation they felt on being

withdrawn from the trials would suggest otherwise.

One reason for the mismatch of quality of life scores

with the interview data could be that the questionnaires

asked patients to rate how they have been feeling over

the last week, whereas the interviews allowed for a much

broader coverage of time and also for a deeper

description of the issue being discussed. Another reason

could be that ratings were made before the interview and

were based on what came to mind in that short rating

interval. Ratings are often more accurate when made

after a reflected or communicated exploration of the

issue. However, these examples do not explain the

fundamental problem with trying to link data obtained

from quality of life questionnaires and in-depth inter-

views which was that patients gave a rating for one


aspect of their lives but talked about it in a different way

when interviewed about the same issue.

Patients’ responses to being asked to complete the

quality of life questionnaires were also interesting to

note. During interviews patients made reference to the

questionnaires they had been asked to fill in. When

prompted for their thoughts regarding how well the

questionnaires captured their experience, patients de-

scribed the forms as being ‘a useful guide for the doctor’

but identified that they gave ‘no real indication’ of what

else they felt, or of what they meant by scoring

themselves at a particular level. In addition patients

often struggled with where they were on the scale against

‘what was normal’.

The idea of considering where one is in relation to

‘being normal’ may be an important factor in explaining

the lack of statistically significant change in the scores

over the course of trial participation. When completing

the questionnaires and during subsequent interviews it

was apparent that patients had shifted in their own

perceptions of what was ‘normal’ for them and what

they considered an acceptable quality of life. The

questionnaires’ lack of sensitivity to any such changes

could therefore be due to the phenomenon that Allison,

Locker, & Feine (1997) describe as within-subject

quality of life dynamism or which Sprangers & Schwartz

(1999) refer to as response shift (meaning that an

individual changes the standards by which he/she

assesses his/her quality of life). Indeed patients com-

mented on this very issue in their interviews. Some of

these patients were dealing with physical problems and a

life of uncertainty, but despite their desperate situation,

they still felt that life was worth living.

Interview material also indicated that for these

patients quality of life was a much broader concept

than the criteria expressed in the essentially disease-

oriented quality of life questionnaires. This conclusion

relates also to the case studies. While at an individual

level the numerical data appeared to reflect the trial

experience ascertained by in-depth interview, the num-

bers alone would have been meaningless. It was the

interview material that explained the scores obtained

and any changes in the scores over time. In effect the use

of in-depth interviews allowed a greater exploration of

patients’ trial experiences in a more comprehensive way

than would have been possible by relying on quality of

life questionnaires alone.

Conclusion

The observation that interviews provided evidence not

offered by questionnaires does not mean, however, that

these tools should be entirely disregarded. Due to

limitations in sample size and lack of comparative data,

it is very difficult to judge the quality of these tools from

their use in this study. Questions can also be raised

about the appropriateness of the quality of life

questionnaires used in this study. This group of patients,

while all having a diagnosis of cancer, were at the end

stage of their disease. It could be argued that it would

have been more appropriate to select a tool that had

been developed to assess quality of life in populations

who are dying or at the end of their disease trajectory,

rather than trial populations, an hypothesis which could

be tested in future research. Instead what these results

suggest is that these quality of life questionnaires appear

to offer a reasonable indication of the toxicity of a

treatment and the extent of deterioration in an

individual’s physical condition. In this respect ques-

tionnaires can remain useful in the clinical setting, to

highlight areas clinicians should pursue further with

their patients. However, they do not reveal much about

how patients are coping with and reacting to their illness

and physical condition on a deeper level and they

probably need to be combined with another information

source if the numerical data is to make any sense and be

meaningful in these respects. In terms of clinical research

they may be useful with large samples of patients or

when two groups of patients are being compared.

However, caution is still needed. As Osoba, Rodrigues,

Myles, Zee, and Pater (1998) have pointed out, the

clinical interpretation of the meaning of small numerical

differences is uncertain and therefore even a statistically

significant finding in a change in the scores over time or

a difference between two groups undergoing particular

treatments reveals little about what patients are experi-

encing, how health care staff can intervene to help them

and what quality of life is really all about.

Acknowledgements

Thanks are due to Professor James Carmichael (CRC

Academic Department of Clinical Oncology, University

of Nottingham) and Professor Veronica James (School

of Nursing, University of Nottingham). This research

was funded by the Cancer Research Campaign (grant

no. CP 1037/0101).

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Documents

Assessing the quality of life of patients in phase I and II anti-cancer drug trials: interviews versus questionnaires