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IntJCancerManag.2020September;13(9):e103647. doi: 10.5812/ijcm.103647.
Publishedonline2020September7. SystematicReview
TheEffectsofLifestyleModificationsIncludingDietaryandPhysical
InterventionswithCognitive-BehavioralTherapyonQualityofLife
andCancer-RecurrenceRateamongPatientswithBreastCancerand
Survivors: AProtocolforaSystematicReviewandMeta-Analysisof
RandomizedControlledTrial
ElhamRazmpoosh1,MaryamMazloom1,MaryamBassiri1,AliMontazeri 2, AkramSajadian1,*,Mitra
Zarrati3 andAminSalehi-Abargoueil4,5
1IntegrativeOncologyandQualityoflifeDepartment,BreastCancerResearchCenter,MotamedCancerInstitute,AcademicCenterforEducation,Culture,andResearch
(ACECR),Tehran,Iran
2IranianInstituteforHealthSciencesResearch,Tehran,Iran
3DepartmentofNutrition,SchoolofPublicHealth,IranUniversityofMedicalSciences,Tehran,Iran
4DepartmentofNutrition,FacultyofHealth,ShahidSadoughiUniversityofMedicalSciences,Yazd,Iran
5NutritionandFoodSecurityResearchCenter,ShahidSadoughiUniversityofMedicalSciences,Yazd,Iran
*Correspondingauthor:IntegrativeOncologyandQualityof lifeDepartment,BreastCancerResearchCenter,MotamedCancerInstitute,Tehran,Iran.Email:
assajadi@yahoo.com
Received2020April26;Revised2020July20;Accepted2020July21.
Abstract
Context:Lifestylemodificationsconsistofthreecomponentsincludingdiet,exercise,andcognitive-behavioraltherapywhichcan
reduce side effects of breast cancer. Cognitive-behavioral therapy is a complementary strategy that promotes new skills for any
treatment. Publishedtrialshaveinvestigatedtheco-efficaciesof thetwoorthreecomponentsof lifestylemodifications,especially
dietaryandcognitive-behavioralinterventionsinbreastcancersurvivors.
EvidenceAcquisition: Thisprotocolisaboutameta-analysiswhichwillsystematicallyreportthesimultaneouseffectsof dietary
intervention or physical activity with cognitive-behavioral therapy, or three of them on quality of life, the recurrence levels and
anthropometricmeasurementsamongpatientswithbreastcancerandsurvivors. ItwaspreparedinaccordancewiththePRISMA-
P checklist and will be performed in accordance with the Cochrane Handbook for Systematic reviews of intervention. Cochrane
Central Register of Controlled trials, PubMed, EMBASE and ISI web of science will be searched for peer-reviewed literature using
definedMeSHterms.Includedrandomizedcontrolledtrialsonthecombinationeffectsofcognitive-behavioraltherapywitheither
dietaryorphysicalinterventionswillbeassessed.Continuousdatawillbemeta-analyzedusingtheSTATAandwillbegatheredusing
random-effects models. The effect size will be reported as standardized mean difference with 95%CIs. Heterogeneity assessment,
publicationbias,andsensitivityanalysiswillbeperformed.Theheterogeneitybetweensometrialsmaybealimitationofthisstudy.
Conclusions: This meta-analysis will provide beneficial guidance for healthcare providers and family members to improve the
currentunderstandingoftheroleoflifestylemodificationonalleviatingtheimportantproblemsofpatientswithbreastcancer.
Keywords:QualityofLife,BreastNeoplasms,Diet,Exercise,CognitiveTherapy
1. Context periodisaconcernandcanaffectthebreastcancerrecur-
rence. Hence, related interventions by maintaining or en-
1.1. Rationale hancinglifestyle modifications can increase their overall-
wellbeing (2). Furthermore, lifestyle modifications are
Breast cancer is the most frequent cancer among highly recommended to patients with breast cancer dur-
women. The estimated five-year relative survival rate for ing or after their treatments as an adjunct to standard
50to69-year-oldwomendiagnosedwithbreastcancerbe- breast cancer therapies in order to increase their quality
tween 2001 and 2013 is over 80% (1). Overall, well-being of life (3, 4). Quality of life is an important factor for ev-
ofpatientsaftertheircancerdiagnosisandpost-treatment
Copyright© 2020,Author(s).Thisisanopen-accessarticledistributedunderthetermsoftheCreativeCommonsAttribution-NonCommercial4.0InternationalLicense
(http://creativecommons.org/licenses/by-nc/4.0/)whichpermitscopyandredistributethematerialjustinnoncommercialusages,providedtheoriginalworkisproperly
cited.
RazmpooshEetal.
eryhumanbeing,especiallyforpatients,whichisaffected control arm (17). Further, cognitive-behavioral therapy
bytheconditionof diseaseandthelengthof patient’slife has been shown to have additional benefits to patients’
(5). The exact concept of quality of life is hard to describe mood and quality of life (18). However, in spite of such
and it mostly relies on the particular comprehension of beneficial effects, insignificant or contrary findings were
diseaseandhealth;however,accordingtothephrasegiven alsoreported(19).
by the World Health Organization (WHO), quality of life Asmentionedabove,therearepublishedclinicaltrial
includes not only mental, physical, and social health but articlesthatassessedcognitive-behavioraltherapywithei-
cognitive-behavioralworkingabilityandlife-longpleasure ther dietary intervention or physical activity as well as
which can be measured via different validated scales (5). thesimultaneouseffectsof threeof themamongpatients
Ontheotherhand,basedontheNaturedefinition,lifestyle with breast cancer and survivors (20-25). Meffered et al.
modifications not only altering diet and physical activity (20) postulated that the combined intervention of the
butalsohavingnewbehavioralchangesforalongtime(6). threelifestylemodificationsaspectscoulddecreasethere-
With regard to the dietary feature of lifestyle modifi- currence rate and prevent the obesity risk in overweight
cations, related principal aspects include energy intake, breastcancersurvivors.Sanftetal.(22)alsofoundthatthe
dietary fiber, dietary fat and carbohydrate intakes, micro- combinationofcognitive-behavioral,physical,anddietary
nutrients, and alcohol consumption (7). Considerable at- interventionsledtoapreventionofthediseaserecurrence
tentionhassubsequentlybeendirectedtowardsenergyre- comparedwiththecontrolgroup.
striction programs that cause reductions in body weight. Withregardtotheprevioussystematicreviewarticles,
Therearenumerousevidencethatshowslosingweightis therearepublishedstudiesthatseparatelyreportedtheef-
associatedwithdecreasedriskofbreastcancerrecurrence ficacies of dietary (26-29), physical (12, 30), and cognitive-
(8, 9) and improved quality of life and psychological well- behavioral intervention (31) on quality of life and disease
being(10).Asaconsequence,thepresentstudywillmainly recurrence of patients with breast cancer and survivors.
focus on dietary modifications related to weight loss that Besides, compared to the present study protocol, there is
generallyincludereducedfatandsimplecarbohydratein- only one systematic review protocol article that has been
takes. publishedin2014andincludedonlydietarymodification
Similar to energy restriction, physical activity also and physical activity features of quality of life and their
causeshigherqualityof life. Aprevioussystematicreview relation with breast cancer recurrence, without consid-
reported that patients with higher physical activity levels ering articles that included cognitive-behavioral therapy
were observed to experience a lower relative risk of can- along with the other two aspects; further, the results of
cer recurrence and had less intense adverse events com- thissystematicreviewprotocolhasnotyetbeenfullypub-
pared with those who had less exercise (11). Further, a re- lished (32). Consequently, there are no meta-analysis or
centmeta-analysisreportedthatexerciseresultedinbene- systematic review articles that specifically report the ef-
ficialeffectsonqualityoflifeandphysicalfunctionsofpa- fects of either dietary or physical activity interventions
tients with breast cancer who had different demographic with cognitive-behavioral therapy or even three of them
orclinicalcharacteristicsduringandfollowingtheirtreat- onqualityoflifeand/orcancerrecurrenceamongpatients
ments(12). with breast cancer and survivors. Hence, performing the
Meanwhile, the third substantial component of present meta-analysis in order to identify lifestyle related
lifestyle modifications is cognitive-behavioral therapy factorsthatcanimprovesurvivalrateandqualityoflifeof
whichcanbeincorporatedintobreastcancersurvivorship patients during or after the treatment process, would be
programs (13). In fact, recent comprehensive lifestyle of great value. The specific strengths of the present study
modification programs consider cognitive-behavioral wouldbeasfollowed:
strategies as the combination factors between dietary In comparison with similar publications, one of the
and physical activity recommendations in order to im- aims of this article is to provide a more specific and pre-
prove patients’ adherence to a long-term treatment cise assessmentontheroleof lifestylemodificationinpa-
(14). Promising data have indicated that performing tientswithbreastcancerandtheefficacyofitsthreeimpor-
multidisciplinary lifestyle modifications would provide tantaspectsincludingdietary,exercise,andpsychological
patients with comprehensive long-term management of interventionsonqualityoflifeofpatientswithbreastcan-
their disease treatment (15, 16). Beneficial effects were cerandsurvivors.
found via cognitive-behavioral therapy; Lichtenthal et As cognitive-behavioral therapy is a complementary
al. showed that cognitive-behavioral intervention led therapythathasshowntohavelong-lastingeffectsonnon-
to improvements in health worries and interpretation communicablediseasessuchasbreastcancer,anotheraim
biases in patients with breast cancer compared with the of this study is to consider those trials that included the
2 IntJCancerManag.2020;13(9):e103647.
RazmpooshEetal.
cognitive-behavioral therapy in the treatment process of sampling methods will be considered. Trials with before-
breastcanceralongwithdietaryorphysicalinterventions. after designs will be primarily excluded. We will exclude
Thismeta-analysiswillprovidebeneficialguidancefor studies if they are animal or in-vitro models. Any records
healthcareprovidersandfamilymemberstoaugmentthe withoutfulltextswillalsobeexcludedaswellasthestud-
currentperceptionofthefunctionofallthelifestylemodi- iesthatareirrelevanttothecontext.
fiablecomponentsonalleviatingtheimportantproblems
of lifestyle of patientswithbreastcancer. 2.2.2. Types of Participants
Thebeneficialresultswillprolongthelifeofbreastcan- Eligibleparticipantswillincludepatientsaged18to65
cersurvivors. withbreastcancerstageItoIIIwhoareundergoingtreat-
The primary objectives of the present study are as- mentprocessaswellasbreastcancersurvivorswhohave
sessing the simultaneous effects of dietary intervention completed their treatments in the previous 10 years. No
or physical activity with cognitive-behavioral therapy, or ethnicitylimitationwillbeconsidered.
three of them, as the main aspects of lifestyle modifica-
tion on quality of life and the recurrence levels among
patients with breast cancer/survivors. The secondary ob- 2.2.3. Types of Intervention
jectives include the assessment of the above-mentioned Intervention types of included RCTs will consist of
lifestyle modification factors on anthropometric factors, lifestyle modificationincludingthreemainaspectswhich
including weight, body mass index (BMI), waist-hip ratio, are dietary interventions, physical activity, and cognitive-
and/orbodyfat. behavioral interventions. Dietary interventions will con-
sistof dietarycounselingandprogramsincludingparticu-
lardietsforweightmanagementsuchasalow-caloriediet,
2. EvidenceAcquisition low-carbohydrate,and/orlow-fatdietsthatareperformed
individually or through group meetings or those that are
2.1. Design givenbytelephonecallsormailcorrespondence,particu-
Thissystematicreviewandmeta-analysisprotocolwas larforweightmanagement.Wewillnotconsiderotherdi-
prepared in accordance with the PRISMA-P checklist (Ap- etary modifications that include smoking cessation, alco-
pendix1inSupplementaryFile)(33).Withregardtothein- holconsumption,ordifferentsupplementtherapies.Phys-
structions, this protocol of a systematic review was regis- icalactivityinterventionwillconsistofanytypeofexercise
tered according to the International Prospective Register with different duration. Trials with cognitive-behavioral
of SystematicReviews(PROSPERO)on24July2018andthe interventions will be included which have been given ei-
last update was on 25 November 2019 (registration num- therviaaface-to-faceconversationorbyonlinemode.
ber: CRD42018100628). It will be conducted according to
a format brought in the Cochrane handbook for system- 2.3. InformationSources
aticreviewsofintervention(34)andtherelateddatawillbe
reportedfollowingtherecommendationsofPRISMAstate- Onereviewer(ER)willsearchelectronicdatabases, in-
ment(35). Quantitativeextracteddatafromincludedran- cludingScopus,ISIWebofScience,Pubmed,theCochrane
domizedclinicaltrials(RCTs)willbemeta-analyzed. CentralRegisterof ControlledTrials,CINAHL,andEMBASE
for peer-reviewed literature. No time limitations will be
2.2. Eligibility Criteria consideredandthesearchwillbeperformedafterthesub-
mission.
2.2.1. Types of Studies The search strategy will include related keywords of
This review study will only include either full-scale breastcancerwhichwillbeseparatelycombinedwiththe
or pilot randomized controlled trials that assessed the synonymsof eitherof thedietaryintervention, cognitive-
dietary or physical activity interventions with cognitive- behavioraltherapy,orphysicalactivity(Appendix2inSup-
behavioral therapy or the combination of three of them, plementaryFile).
comparedtoacontrolorusualcare.Typesofblindingofin- WewillalsoperformGreyliteraturebythe“GREYMAT-
cludedarticleswillnotbeconsideredastheinclusioncri- TERS” checklists which are from the Canadian Agency for
teria and will only be assessed according to the quality as- DrugsandTechnologiesinHealth(CADTH).
sessment tools. The control group for every intervention Therewillbenolanguagerestrictionsandthesearches
partcanbeeitherawatchful-waitlistaspassivecontrolor willbere-conductedrightbeforethefinalanalysis.Transla-
groupsthatreceivedotherstandardcaremanagementor tiontoolswillbeusedforarticlesinlanguagesotherthan
placeboasactivecontrol.Nolimitationsforsamplesizeor English.
IntJCancerManag.2020;13(9):e103647. 3
RazmpooshEetal.
2.4. Search Strategy details of the interventions and durations versus the con-
Relatedkeywordsthatwillbeusedinthesearchstrat- trolgroups.
egy will consist of selected keywords from the Medical 4) Outcomemeasuresandtheirdefinitionsandunits;
Subject Headings (MeSH) database and the other non- the drop-out and completion rates, the measurement
MeSHterms. TheMeSHtermswillbemadeforsequential tools, and the final analysis with or without adjusted vari-
searches. Othersynonymsof everythreeof themaincom- ablesandtheper-protocolorintention-to-treatanalysis.
ponents will also be searche’d separately. Final search re- Data will be separately entered for studies that have
sultswillbeconcatenatedwithBOOLEANoperatorsinclud- morethanoneoutcomemeasureinordertoconductin-
ing “OR” for the synonyms and “AND” for every combina- dividualanalysis.Wewillcalculatethemeandifferencesof
tion between the “breast cancer” component and each of selecteddatainSPSS(version20,IBM,ChicagoIL,USA).Data
thethreeinterventionkeywords. type in the present meta-analysis will be means and stan-
dard deviations of continuous data among participants
either in the intervention or control groups and if data
2.5. Study Records present in forms other than means and standard devia-
2.5.1. Data Management tions, they will be accordingly converted in order to con-
Two researchers (AS and ER) will conduct the main ductthepooledanalysis. Tworeviewerswillrevisetheac-
management of the study. Data collection will be per- curacy of the extracted data (AS and ER) and they will re-
formedaccordingtothePRISMAflowdiagramforreport- solve any discrepancies or disagreement through group
ing systematic reviews and meta-analyses studies (36). discussionbyre-checkingtheextracteddataandfulltexts
Hence, all of the pooled records will be automatically du- of all articles.
plicated. As finding duplicates via EndNote software (ver-
sion 8.2, Thomson Reuters, Philadelphia, USA) are inad- 2.6. OutcomesandPrioritization
equate, further duplication will be performed via hand- The following primary and secondary outcome mea-
searching. surementswillbeevaluatedandanalyzedbasedonthere-
porteddatafromeveryincludedtrial:
2.5.2. Selection Process
Fivereviewers(AS,ER,MZ,MB,andAM)willperformthe 2.6.1. Primary OutcomesMeasure
screeningoftitlesandabstractsofstudiesaccordingtothe Qualityof lifeanddiseaserecurrencerates.
mentionedinclusionandexclusioncriteria. Allreviewers
willmeetandcomparetheirscreeningatleastthreetimes 2.6.2. SecondaryOutcomesMeasure
to compare and discuss the related results. If any doubt Anthropometricfactors,includingweight,BMI,waist-
still exists, the full text of the related studywillbechecked hipratio,and/orbodyfat.
formorepreciseassessment.
2.5.3. Data Collection Process 2.7. Quality Assessment
Thefivereviewers(AS,ER,MB,MZ,andAM)willreview 2.7.1. Risk of Bias Assessment
thefulltextsofarticlesandwillperformdataextractionin- The risk of bias of all the included studies will be as-
dependentlyforeachstudyviaastandardizedformwhich sessedonebyonebythereviewersusingtheCochranecol-
isfromtheCochraneDataCollectionforRandomizedCon- laboration’s risk of bias assessment tool (38, 39). There
trolled trials (37). The data which will be extracted are as will be Six main domains of bias which will be assessed,
followed: including selection, attrition, detection, performance, re-
1) The basic characteristics of the study including the porting bias, and other biases, all of which will be evalu-
authornames,publicationyearandtheregionofthepub- ated through the Review Manager software and then will
lished article as well as the methodological quality and be classified as either “high-risk”, “low-risk” or “by some
the design of each study including randomized or non- concern”(39).Thedisagreementswillbecheckedthrough
randomized,pilot,orfulltrials. meetingsintheBreastCancerResearchCenter.
2) Characteristics of trial participants including total
participants, age, breast cancer stage, type of treatment, 2.7.2. Quality of Evidence
breastcancerbiologicalsubtype,andethnicity. We used the Grading of Recommendations Assess-
3)Typeofinterventionsincludingdietorexerciseinter- ment,Development,andEvaluation(GRADE)approachto
vention with psychotherapy or three of them along with assessthequalityof evidenceforeachoutcomeaccording
4 IntJCancerManag.2020;13(9):e103647.
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