Longitudinal Assessment of Longitudinal Assessment of Cancer-related Fatigue:Cancer-related Fatigue:

When to use it? What does it add?When to use it? What does it add?

Charles S. Cleeland, PhDCharles S. Cleeland, PhD

Department of Symptom ResearchDepartment of Symptom Research

The University of Texas The University of Texas M. D. Anderson Cancer CenterM. D. Anderson Cancer Center

Fatigue Related To Cancer Fatigue Related To Cancer TreatmentTreatment

Severe fatigue may be an issue for a defined Severe fatigue may be an issue for a defined period of time – treatment and posttreatmentperiod of time – treatment and posttreatment

Fatigue related to cancer treatment is:Fatigue related to cancer treatment is: a major problem for cancer patientsa major problem for cancer patients a major toxicity of cancer treatmenta major toxicity of cancer treatment a reason for treatment delays or discontinuationa reason for treatment delays or discontinuation

Treatment-related fatigue is an excellent target Treatment-related fatigue is an excellent target for a wide variety of interventionsfor a wide variety of interventions

Measurement IssuesMeasurement Issues

Need for multiple measurements across a Need for multiple measurements across a specified periodspecified period

Calls for use of a minimal number of itemsCalls for use of a minimal number of items Need for methods of analysis that portray Need for methods of analysis that portray

the critical time elementthe critical time element Missing data can be a problemMissing data can be a problem

FatigueFatigue and and PainPain under Cancer Therapies under Cancer TherapiesOther MDASI Items:Other MDASI Items: SleepSleep, , DistressDistress, , Shortness of BreathShortness of Breath

NSCLC Post Thoracic Surgery WeeksNSCLC Post Thoracic Surgery Weeks

AML/MDS Allo-HSCT DaysAML/MDS Allo-HSCT Days

NSCLC Chemo-radiation DaysNSCLC Chemo-radiation Days

GI Chemo-radiation DaysGI Chemo-radiation Days

Top 4 Symptoms in Head and Neck CancersTop 4 Symptoms in Head and Neck Cancers

Sev

erity

Weeks

0

2

4

6

8

10taste fooddry mouthfatiguemucus

XRT Only (n=46)

Burkett et al, 2007, unpublished data

Sev

erity

END 0 1 2 3 4 5Tx

7 8 9 10

Weeks

0

2

4

6

8

10

0 1 2 3 4 5Tx

7 8 9 10END

Chemo + XRT (n=48)

Example: Fatigue Severity Across Time Example: Fatigue Severity Across Time F

atig

ue

Sev

erit

y

0 1 2 3 4 5 End of Tx

7 8 9 10

Time Point

0

1

2

3

4

5

6

7

ChemoXRT (n=48)XRT only (n=46)

Pre/Post Outcome MeasuresPre/Post Outcome Measures

• Benefits• Ease of data gathering • No need keep track of

patients across a treatment regimen

• Less resource utilization (e.g., staff burden)

• Drawbacks• Limited in scope• Lose impact of symptom

between assessments• Partial picture of symptom

expression

t (93)= -.032, p = .97

Burkett et al, 2007, unpublished data

x= 2.04

x= 2.02

PRE

POST

Fatigue Area Under the Curve (AUC): Fatigue Area Under the Curve (AUC): Effectively Combining Severity and TimeEffectively Combining Severity and Time

Longitudinal DataLongitudinal Data• Frequent assessment is

invaluable• Enables tracking of symptoms

across treatment regimens• Provides picture of symptom

change as the treatment and recovery progresses

Area Under the CurveArea Under the Curve • Single value represents time and

symptom severity• Compares groups using standard

statistical methods• Compensates for missing data

Burkett et al, 2007, unpublished data

0

10

20

30

40

50

60

Bas

elin

e

Wee

k 2

Wee

k 3

Wee

k 4

Wee

k 5

End

of

Tx

Wee

k 7

Wee

k 8

Wee

k 9

Wee

k 1

0

Timepoint

Ave

rage

Fat

igue

AU

C

CXRT (n=48)

XRT Only (n=46)

t (93)=6.41, p = .04 *

SummarySummary

Longitudinal measurement using a single Longitudinal measurement using a single item can describe a symptom over a item can describe a symptom over a critical time periodcritical time period

We need different ways of thinking about We need different ways of thinking about summarizing the datasummarizing the data

Frequent measurement is a challengeFrequent measurement is a challenge Diaries have inherent problemsDiaries have inherent problems ePRO may be the best way to captureePRO may be the best way to capture