Impact of a novel nurse.docx

8/18/2019 Impact of a novel nurse.docx

1/17

Impact of a novel nurse-ledprechemotherapy education intervention

(ChemoEd) on patient distress, symptom burden, and treatment-relatedinformation and support needs: resultsfrom a randomised, controlled trial

1. S. Aranda 1 , 2 , *,2. M. Jeford 1 , 2 , 3 ,3. P. Yates 4 ,4. K. Gough 1 , 5. J. Seymour 2 ,3 ,6. P. ran!"s 3 ,#. $. %ara&e''" 1 ,(. S. %reen 1 , 2 and). P. S!ho*e'd 1 , 2

+ Author Afliations1. 1Department o Nursing and Supportive Care Resear h! "eter #a Callum Can er Centre!

#el$ourne2. 2%a ult& o #edi ine! Dentistr& and 'ealth S ien es! (niversit& o #el$ourne3. 3Division o 'aematolog& and #edi al )n olog&! "eter #a Callum Can er Centre!

#el$ourne4. 4S hool o Nursing! ueensland (niversit& o +e hnolog&! ,ris$ane! Australia

1. *- Correspondence to: "ro . S. Aranda! Department o Nursing and Supportive Care Resear h! "eter#a Callum Can er Centre! o /ed ,ag 1! A0,e /ett Street! #el$ourne! i toria ! Australia. +el5 6 17378 9 73: 3; %aunimel$.edu.au

• Re eived April 22! 2 1 .• Revision re eived ) to$er 2 ! 2 1 .

• Revision re eived ?anuar& 18! 2 11.• A epted ?anuar& 2 ! 2 11.

Ne


2/17

esu'ts- Chemo=d did not signiG antl& redu e patient distress. 'o ever! a signiG antde rease in sensor&Hps& hologi al P I . 2:B and pro edural P I . 3B on erns! as

ell as prevalen e and severit& o and $other due to vomiting all P I . 1B! ereo$served at +3. Jn addition! su$group anal&sis o patients ith elevated distress at +1indi ated a signiG ant de rease P I . 39B at +2 $ut not at +3 P I . 99B in Chemo=dpatients.

$on!'us"ons- Chemo=d holds promise to improve patient treatment7related on ernsand some ph&si alHps& hologi al out omes; ho ever! urther resear h is reEuired onmore diverse patient populations to ensure generalisa$ilit&.

Key words

• an er

• hemotherap&

• distress

• patient edu ation

• s&mptom $urden

"revious Se tion Ne


3/17

mu ositis K 1 ! 1: M or atigue! as a result o hanges to patient edu ation K 1 M. +hus! theoverall eviden e $ase or preparation o patients or hemotherap& is limited.

iterature regarding the preparation o patients or potentiall& threatening medi alpro edures K 8 ! 18 ! 2 M! as ell as health edu ation resear h K 21 M! provides a ro$ust

rame or/ that an $e adapted to the pre hemotherap& setting. =viden e rom otherpatient settings! predominantl& surger&! suggests that the provision o adeEuate and

timel& sensor&! ps& hologi al! and pro edural in ormation has $road $eneGts! in ludingredu ed ps& hologi al distress K 8 ! 2 ! 22 M. +he trial reported here s&stemati all& appliedthis and other relevant literature to the development o a nurse7led edu ationintervention Chemo=dB or patients ommen ing their Grst ever hemotherap&treatment. =valuation o Chemo=d o ussed on ommon hemotherap&7related

on erns in luding ps& hologi al distress! treatment7related in ormation and supportneeds! and s&mptom $urden. Assessment o s&mptom $urden in luded measurement o $oth severit& and $other aused $& si< ommonl& e


4/17

to their high prevalen e in the an er population and to assess the intervention in $othsolid and nonsolid tumour groups.

study design

A parallel group7prospe tive randomised! ontrolled trial as underta/en ith patientsrandomised to re eive Chemo=d or routine areHpre hemotherap& edu ation. ,aselinedata +1B ere olle ted in the ee/ pre eding patients0 Grst ever hemotherap&.Randomisation as ompleted via random num$er generator ith stratiG ation or

an er t&pe and treatment to


5/17

routine care/prechemotherapy education

Routine are onsisted o a nurse7led edu ation session overing ommon side7e e tso hemotherap& provided on the Grst da& o treatment either in the treatment hair oa shared ard or in the ommunal aiting area. +he edu ational D D used in Chemo=d

as reel& availa$le in the hemotherap& da& unit; there ore! use o this resour e asmonitored. No ollo 7up patient onta ts ere s heduled as part o routine are.outcome measurement

@ritten in ormed onsent as o$tained at +1 $e ore randomisation and $e ore an&stud& pro edures. "atients ompleted sel 7administered Euestionnaires in outpatient

lini s at +1! +2! and +3.

clinical data

Jn ormation on =C)Q per orman e status! an er t&pe! stage! and treatment regimenas olle ted rom the patient re ord.

demographic data

Age and gender ere olle ted rom the patient re ord. )ther items ere olle ted at +1 in the patient7 ompleted Euestionnaire marital status! urrent emplo&ment!edu ation! and ountr& o $irthB.

psychological distress

"s& hologi al distress as assessed ith the 'ospital An


6/17

severit& o that s&mptom 1 I mild to 3 I severe B and the e


7/17

)dds ratios and "earson0s W 2 ere used to assess the relationship $et een theprevalen e o ommon hemotherap& side7e e ts and stud& group at +1 and +3. #annL@hitne& U tests ere used to assess the impa t o Chemo=d on the severit& o and$other aused $& ommon hemotherap& side7e e ts. A more stringent alpha o . 1

t o7tailedB as emplo&ed to orre t or multiple testing.=


8/17

ontrol parti ipants reported at hing the D D. +he average time or the ompletion opre hemotherap& edu ation intervention 1B as 4 .3 min \19. 3B and or routine

are edu ation 24.2 min \1 .43B. Average time ta/en to omplete interventions 2 and3 ere 8. 4 \4.92B and 19.82 \:.24B min! respe tivel&.%idelit& assessment o the re orded intervention sessions ill $e reported else here $ut

ompleteness o all intervention elements ranged rom :2V to 4V! ith no signiG ant

degradation o intervention nurse per orman e over the duration o the stud&. +hereas no di usion into usual are identiGed during assessment o the audiotapes. Almostall 84V! n I 82B patients ompleting +3 measures re eived all three intervention

omponents.

uestionnaire compliance

Complian e ith Euestionnaires as high F84VB at all planned assessmentssupplemental Appendi< S2 ! availa$le at Annals of Oncology onlineB ith minimal

missing items or all s ales and su$s ales T1. VB.

psychological distress

At +1! mean 'ADS s ores did not di er signiG antl& $et een groups! t 1 8B I .:2! P I.4:. At +2 a ter deliver& o the Grst intervention sessionB and +3! ps& hologi al

distress s ores improved more on average in the treatment than in the ontrol group;ho ever! these di eren es ere not signiG ant +a$le 2 B.

ie this ta$le5• Jn this indo

• Jn a ne indo

/a0'e 2.Results o Chemo=d trial or ps& hologi al distress 'ADSB

cancer treatment-related concerns

At +1! mean S"C s ores did not di er signiG antl& $et een groups! t 18 B I ] .98! P I.9 ! hereas mean "C s ores ere signiG antl& higher in the Chemo=d group! t 18 B I

]2.3! P I . 22. AdZusting or di eren es in +1 s ores! su$s ale s ores at +3 indi ated asigniG ant improvement in the Chemo=d group on $oth the S"C P I . 2:B and the "CP I . 3B su$s ales +a$le 3 B.


• Jn a ne indo

/a0'e 3.Results o Chemo=d trial or the Can er +reatment S ale

prevalence and severity of and bother caused by si! common chemotherapy side-effects

At +1! there ere no signiG ant $et een7group di eren es in terms o prevalen e!severit&! and $other related to individual side7e e ts. @hile there ere e signiG antdi eren es at +3! prevalen e o vomiting as ell as the severit& o and $other aused$& vomiting ere redu ed in patients re eiving Chemo=d all P I . 1B +a$le 4 B.


• Jn a ne indo

/a0'e 4.Results o the Chemo=d +rial or si< ommon hemotherap& side7e e ts C7SASB

http://annonc.oxfordjournals.org/cgi/content/full/mdr042/DC1http://annonc.oxfordjournals.org/cgi/content/full/mdr042/DC1http://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042.full#T2http://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042/T2.expansion.htmlhttp://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042/T2.expansion.htmlhttp://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042.full#T3http://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042/T3.expansion.htmlhttp://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042/T3.expansion.htmlhttp://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042.full#T4http://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042/T4.expansion.htmlhttp://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042/T4.expansion.htmlhttp://annonc.oxfordjournals.org/cgi/content/full/mdr042/DC1http://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042.full#T2http://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042/T2.expansion.htmlhttp://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042/T2.expansion.htmlhttp://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042.full#T3http://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042/T3.expansion.htmlhttp://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042/T3.expansion.htmlhttp://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042.full#T4http://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042/T4.expansion.htmlhttp://annonc.oxfordjournals.org/content/early/2011/04/06/annonc.mdr042/T4.expansion.html


9/17

e!ploratory subgroup analysis"distress

"rerandomisation! a total o 94 patients K ontrol! n I 2 2 VB; intervention! n I 228VBM reported elevated distress levels +a$le 9 B. At +1! mean 'ADS s ores or patientsith elevated distress ere signiG antl& higher in the ontrol group! t 92B I 2.2! P I. 39. A ter adZusting or +1 s ores! a signiG ant de rease in ps& hologi al distress at

+2 P I . 39B as o$served in Chemo=d parti ipants; ho ever! this $et een7groupdi eren e as not maintained at +3 P I . 99B.ie this ta$le5

• Jn this indo

• Jn a ne indo

/a0'e 5.Results o the Chemo=d trial or patients identiGed as ps& hologi all& distressed aat$aselineH+1 post hoc planned su$group anal&sisB

sample si#e and statistical power

Due to s heduled hanges in patient pre hemotherap& edu ation as part o usual arehanges to patient edu ation materials and timing o edu ationB! in om$ination ith

slo er7than7anti ipated re ruitment rates! the trial as losed prematurel& to avoidpotential on ounding o stud& out omes. +his meant that ith a Gnal sample o 182patients! post hoc po er anal&sis t o7sided 9V signiG an e level; sample siUe group 1I 8 ! sample siUe group 2 I 84B or a small e e t d I .3 B indi ated a 94V pro$a$ilit&that statisti al signiG an e ould $e indi ated on the primar& end point! hereas the

orresponding pro$a$ilit& or a moderate e e t d I .9 B as 83V."revious Se tion Ne


10/17

demonstrates that stru tured approa hes! su h as the use o intervention he /lists!ma& $e use ul additions to routine pra ti e to ensure patients a ess availa$le supportmaterials. A ess to appropriate in ormation and support materials su h as D D andsel 7 are $ro huresB is li/el& to help redu e treatment7related in ormation and supportneeds.

Although this stud& suggests that the Chemo=d intervention is superior to urrentroutine are! the stud& has several limitations. %irst! despite $eing more than t i e aslarge as an& prior evaluation o a nurse7led pre hemotherap& edu ation programK12 ! 14 M! e annot rule out the possi$ilit& that our Gndings ma& have $een limited $&our sample siUe and that a larger sample ma& have allo ed us to dete t smaller$et een7group di eren es on our primar& out ome varia$le. 'o ever! anal&ses or allse ondar& out ome varia$les! as ell as su$group anal&ses! ere suf ientl& po eredand all o$served di eren es orresponded ith lini all& meaning ul hanges. Se ond!the stud& as underta/en at a single spe ialist an er hospital and studied a limitedpatient population. @hether this approa h an $e applied su ess ull& to people ithother an er t&pes and those treated at nonspe ialist entres reEuires urthere


11/17

onsideration o pra ti al aspe ts su h as the ost o additional nursing time andstrategies to in rease the impa t o su h interventions on patient out omes.

"revious Se tion Ne


12/17

4. 4.

1. Carelle N!2. "iotto =!3. ,ellanger A!4. et al

. Changing patient per eptions o the side7e e ts o an er hemotherap&. Can er 2 2;89519971 3.CrossRe #edline @e$ o S ien e Qoogle S holar

9. 9.

1. Coates A!2. A$raham S!3. `a&e S,!4. et al

. )n the re eiving end[patient per eption o the side7e e ts o an er hemotherap&. =ur ? Can erClin )n ol 18 3;1852 372 .CrossRe #edline @e$ o S ien e Qoogle S holar

. .

1. Qrifn A#!2. ,uto "N!3. Coates AS!4. et al

. )n the re eiving end 5 patient per eptions o the side7e e ts o an er hemotherap& in 1883. Ann)n ol188 ;:51 87189.A$stra tH %R== %ull +e


13/17

1. Sanson7%isher R!2. Qirgis A!3. ,o&es A!4. et al

. +he unmet supportive are needs o patients ith an er. Supportive Care RevieQroup. Can er 2 ; 522 723:.CrossRe #edline @e$ o S ien e Qoogle S holar

12. 12.

1. Dodd #?. =f a & o proa tive in ormation on sel 7 are in hemotherap& patients. "atient =duCouns 18 ;1152197229.CrossRe #edline @e$ o S ien e Qoogle S holar

13. 13.

1. +homas R!2. Dal& #!3. "err&man ,!4. et al

. %ore arned is orearmed[$eneGts o preparator& in ormation on video assette or patientsre eiving hemotherap& or radiotherap&[a randomised ontrolled trial. =ur ? Can er 2 ;3 5193 71943.CrossRe #edline @e$ o S ien e Qoogle S holar

14. 14.

1. `innane N!2. +hompson

. =valuation o the addition o video7$ased edu ation or patients re eiving standard pre7hemotherap& edu ation. =ur ? Can er Care2 ;1:532 7338.

CrossRe @e$ o S ien e Qoogle S holar19. 19.

1. @illiams SA!2. S hreier A#

. +he e e t o edu ation in managing side7e e ts in omen re eiving hemotherap& or treatment o$reast an er. )n ol Nurs %orum2 4;315=1 7=23.CrossRe #edline Qoogle S holar

1 . 1 .

1. Dodd #?!2. arson "?!3. Di$$le S !4. et al

. Randomised lini al trial o hlorhe


14/17

2. Aranda S!3. 'argraves #!4. et al

. Randomised ontrolled trial o an edu ational intervention or managing atigue in omen re eivingadZuvant hemotherap& or earl&7stage $reast an er. ? Clin )n ol 2 9;235 2:7 3 .A$stra tH %R== %ull +e


15/17

1. S hoGeld "!2. ?e ord #!3. Care& #!4. et al

. "reparing patients or threatening medi al treatments5 e e ts o a hemotherap& edu ational D Don an


16/17

. +he stru ture o the hospital an


17/17

3. Ri hardson A!4. et al

. +he development o the Chemotherap& S&mptom Assessment S ale C7SASB5 a s ale or the routinelini al assessment o the s&mptom e

Documents

Impact of a novel nurse.docx