title: Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS): rationale and design for meta-analyses of individual patient data of randomized controlled trials that evaluate the effect of physical activity and psychosocial interventions on health-related quality of life in cancer survivors.
abstract: BACKGROUND
  Effective interventions to improve quality of life of cancer survivors are essential. Numerous randomized controlled trials have evaluated the effects of physical activity or psychosocial interventions on health-related quality of life of cancer survivors, with generally small sample sizes and modest effects. Better targeted interventions may result in larger effects. To realize such targeted interventions, we must determine which interventions that are presently available work for which patients, and what the underlying mechanisms are (that is, the moderators and mediators of physical activity and psychosocial interventions). Individual patient data meta-analysis has been described as the 'gold standard' of systematic review methodology. Instead of extracting aggregate data from study reports or from authors, the original research data are sought directly from the investigators. Individual patient data meta-analyses allow for adequate statistical analysis of intervention effects and moderators of such effects.Here, we report the rationale and design of the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) Consortium. The primary aim of POLARIS is 1) to conduct meta-analyses based on individual patient data to evaluate the effect of physical activity and psychosocial interventions on the health-related quality of life of cancer survivors; 2) to identify important demographic, clinical, personal, or intervention-related moderators of the effect; and 3) to build and validate clinical prediction models identifying the most relevant predictors of intervention success.
  
  
  METHODS
  We will invite investigators of randomized controlled trials that evaluate the effects of physical activity and/or psychosocial interventions on health-related quality of life compared with a wait-list, usual care or attention control group among adult cancer survivors to join the POLARIS consortium and share their data for use in pooled analyses that will address the proposed aims. We are in the process of identifying eligible randomized controlled trials through literature searches in four databases. To date, we have identified 132 eligible and unique trials.
  
  
  CONCLUSIONS
  The POLARIS consortium will conduct the first individual patient data meta-analyses in order to generate evidence essential to targeting physical activity and psychosocial programs to the individual survivor's characteristics, capabilities, and preferences.
  International prospective register of systematic reviews, CRD42013003805.
authors.affiliation: Department of Epidemiology and Biostatistics, and the EMGO Institute for Health and Care Research, VU University Medical Center, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands. l.buffart@vumc.nl.
authors.forename: Laurien M
authors.initials: LM
authors.lastname: Buffart
authors.forename: Joeri
authors.initials: J
authors.lastname: Kalter
authors.forename: Mai J M
authors.initials: MJ
authors.lastname: Chinapaw
authors.forename: Martijn W
authors.initials: MW
authors.lastname: Heymans
authors.forename: Neil K
authors.initials: NK
authors.lastname: Aaronson
authors.forename: Kerry S
authors.initials: KS
authors.lastname: Courneya
authors.forename: Paul B
authors.initials: PB
authors.lastname: Jacobsen
authors.forename: Robert U
authors.initials: RU
authors.lastname: Newton
authors.forename: Irma M
authors.initials: IM
authors.lastname: Verdonck-de Leeuw
authors.forename: Johannes
authors.initials: J
authors.lastname: Brug
mesh_terms: D003625:Data Collection / Q000379:methods*; D006801:Humans; D015201:Meta-Analysis as Topic; D009043:Motor Activity; D009369:Neoplasms / Q000523:psychology* / Q000534:rehabilitation*; D011788:Quality of Life; D016032:Randomized Controlled Trials as Topic; D012107:Research Design; D013315:Stress, Psychological / Q000628:therapy; D017741:Survivors / Q000523:psychology
references.citation: JAMA. 1997 Feb 12;277(6):488-94
references.pmid: 9020274
references.citation: Qual Life Res. 1999 Sep;8(6):529-38
references.pmid: 10548868
references.citation: J Sci Med Sport. 2013 Mar;16(2):99-104
references.pmid: 22749527
references.citation: Psychooncology. 2011 Feb;20(2):115-26
references.pmid: 20336645
references.citation: Pain. 2008 Oct 31;139(3):670-680
references.pmid: 18774225
references.citation: Behav Res Methods Instrum Comput. 2004 Nov;36(4):717-31
references.pmid: 15641418
references.citation: Ann Med. 2001 Jul;33(5):337-43
references.pmid: 11491192
references.citation: Cancer. 2001 Sep 15;92(6 Suppl):1689-93
references.pmid: 11598888
references.citation: Cancer Epidemiol Biomarkers Prev. 2009 Oct;18(10):2600-7
references.pmid: 19815635
references.citation: Cochrane Database Syst Rev. 2012 Aug 15;(8):CD008465
references.pmid: 22895974
references.citation: Ann Behav Med. 1999 Spring;21(2):171-9
references.pmid: 10499138
references.citation: Arch Gen Psychiatry. 2002 Oct;59(10):877-83
references.pmid: 12365874
references.citation: Cochrane Database Syst Rev. 2012 Aug 15;(8):CD007566
references.pmid: 22895961
references.citation: Syst Rev. 2012 Feb 09;1:8
references.pmid: 22588015
references.citation: J Clin Oncol. 2007 Dec 20;25(36):5710-4
references.pmid: 17998547
references.citation: Health Care Financ Rev. 2004 Summer;25(4):5-25
references.pmid: 15493441
references.citation: Annu Rev Public Health. 1999;20:309-35
references.pmid: 10352861
references.citation: Ann Behav Med. 2007 Feb;33(1):99-104
references.pmid: 17291175
references.citation: J Natl Cancer Inst. 1993 Mar 3;85(5):365-76
references.pmid: 8433390
references.citation: Jpn J Clin Oncol. 2004 Dec;34(12):717-21
references.pmid: 15640501
references.citation: Support Care Cancer. 1995 Jul;3(4):244-7
references.pmid: 7551627
references.citation: CA Cancer J Clin. 2011 Mar-Apr;61(2):69-90
references.pmid: 21296855
references.citation: Med Sci Sports Exerc. 2003 Nov;35(11):1846-52
references.pmid: 14600549
references.citation: Med Care. 1992 Jun;30(6):473-83
references.pmid: 1593914
references.citation: Oncologist. 2000;5(5):353-60
references.pmid: 11040270
references.citation: Public Health Rep. 1985 Mar-Apr;100(2):126-31
references.pmid: 3920711
references.citation: J Clin Oncol. 1993 Mar;11(3):570-9
references.pmid: 8445433
references.citation: Health Qual Life Outcomes. 2003 Dec 16;1:79
references.pmid: 14678568
references.citation: J Cancer Surviv. 2010 Jun;4(2):87-100
references.pmid: 20052559
references.citation: BMJ. 2010 Feb 05;340:c221
references.pmid: 20139215
references.citation: Cancer. 2008 Apr 15;112(8):1845-53
references.pmid: 18306372
references.citation: Health Psychol. 2006 May;25(3):348-54
references.pmid: 16719606