Preference-based versus randomized controlled trial in prostate cancer survivors: Comparison of recruitment, adherence, attrition, and clinical outcomes
IntroductionPatients’ unwillingness to be randomized to a mode of exercise may partly explain their poor recruitment, adherence, and attrition in randomized controlled trials (RCTs) of exercise in oncology. It is unknown whether a preference-based trial can improve recruitment, adherence, retention,...
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| Format: | Article |
| Language: | English |
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Frontiers Media S.A.
2022-12-01
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| Series: | Frontiers in Oncology |
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| Online Access: | https://www.frontiersin.org/articles/10.3389/fonc.2022.1033229/full |
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| author | Shabbir M. H. Alibhai Shabbir M. H. Alibhai Efthymios Papadopoulos Sara Durbano George Tomlinson George Tomlinson Daniel Santa Mina Paul Ritvo Catherine M. Sabiston Andrew G. Matthew James Chiarotto Souraya Sidani S. Nicole Culos-Reed S. Nicole Culos-Reed |
| author_facet | Shabbir M. H. Alibhai Shabbir M. H. Alibhai Efthymios Papadopoulos Sara Durbano George Tomlinson George Tomlinson Daniel Santa Mina Paul Ritvo Catherine M. Sabiston Andrew G. Matthew James Chiarotto Souraya Sidani S. Nicole Culos-Reed S. Nicole Culos-Reed |
| author_sort | Shabbir M. H. Alibhai |
| collection | DOAJ |
| description | IntroductionPatients’ unwillingness to be randomized to a mode of exercise may partly explain their poor recruitment, adherence, and attrition in randomized controlled trials (RCTs) of exercise in oncology. It is unknown whether a preference-based trial can improve recruitment, adherence, retention, and clinical outcomes compared to a RCT of the same exercise interventions.ObjectiveWe assessed the effects of a 2-arm exercise preference trial on adherence and clinical outcomes compared to a similar 2-arm RCT in men with prostate cancer (PC).MethodsThis was a two-arm preference-based trial of group-based training (GROUP) or home-based training (HOME). PC survivors on androgen deprivation therapy (ADT) who declined randomization to the RCT but chose to participate in a preference trial were recruited in four Canadian centers. All study participants engaged in aerobic and resistance training, 4-5 days weekly for 6 months, aiming for 150 minutes/week of moderate-to-vigorous physical activity. The primary outcomes were changes from baseline to 6 months in fatigue and functional endurance. Secondary outcomes were quality of life, physical fitness, body composition, blood markers, and adherence. Linear mixed models were used to assess the effects of HOME versus GROUP on primary outcomes. In pooled preference and RCT data, the selection effect (i.e., difference between those who were and were not willing to be randomized) and treatment effect (i.e., difference between GROUP and HOME) were estimated using linear regression.Results and conclusionFifty-four participants (mean [SD] age, 70.2 [8.6] years) were enrolled (GROUP n=17; HOME n=37). Comparable effects on primary and secondary outcomes were observed following GROUP or HOME in the preference-based trial. Adherence was similar between preference and RCT participants. However, attrition was higher in the RCT (50.0% vs. 27.8%, p= 0.04). Compared to GROUP, HOME was more effective in ameliorating fatigue (mean difference: +5.2, 95%CI=1.3 to 9.3 p=0.01) in pooled preference and RCT data. A preference-based trial results in comparable observed effects on clinical outcomes and adherence and lower attrition compared with a RCT of the same exercise interventions in PC survivors on ADT. Given the appeals of preference-based trials to study participants, additional studies are warranted.Clinical trial registrationclinicaltrials.gov, identifier (NCT03335631). |
| first_indexed | 2024-04-11T06:08:15Z |
| format | Article |
| id | doaj.art-143c6a59b91c43a592b6160c722c07f1 |
| institution | Directory Open Access Journal |
| issn | 2234-943X |
| language | English |
| last_indexed | 2024-04-11T06:08:15Z |
| publishDate | 2022-12-01 |
| publisher | Frontiers Media S.A. |
| record_format | Article |
| series | Frontiers in Oncology |
| spelling | doaj.art-143c6a59b91c43a592b6160c722c07f12022-12-22T04:41:24ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2022-12-011210.3389/fonc.2022.10332291033229Preference-based versus randomized controlled trial in prostate cancer survivors: Comparison of recruitment, adherence, attrition, and clinical outcomesShabbir M. H. Alibhai0Shabbir M. H. Alibhai1Efthymios Papadopoulos2Sara Durbano3George Tomlinson4George Tomlinson5Daniel Santa Mina6Paul Ritvo7Catherine M. Sabiston8Andrew G. Matthew9James Chiarotto10Souraya Sidani11S. Nicole Culos-Reed12S. Nicole Culos-Reed13Department of Medicine, University Health Network, Toronto, ON, CanadaInstitute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, CanadaDepartment of Medicine, University Health Network, Toronto, ON, CanadaDepartment of Medicine, University Health Network, Toronto, ON, CanadaDepartment of Medicine, University Health Network, Toronto, ON, CanadaInstitute of Health Policy, Management and Evaluation, University of Toronto, Toronto, ON, CanadaFaculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, CanadaDepartment of Psychology, School of Kinesiology and Health Science, York University, Toronto, ON, CanadaFaculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, CanadaDepartment of Surgical Oncology, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, CanadaDepartment of Medicine, Division of Hematology/Oncology, Scarborough Health Network, Scarborough, ON, CanadaDaphne Cockwell School of Nursing, Toronto Metropolitan University, Toronto, ON, CanadaFaculty of Kinesiology, University of Calgary, Calgary, AB, CanadaDepartment of Oncology, Cumming School of Medicine, University of Calgary, Calgary, AB, CanadaIntroductionPatients’ unwillingness to be randomized to a mode of exercise may partly explain their poor recruitment, adherence, and attrition in randomized controlled trials (RCTs) of exercise in oncology. It is unknown whether a preference-based trial can improve recruitment, adherence, retention, and clinical outcomes compared to a RCT of the same exercise interventions.ObjectiveWe assessed the effects of a 2-arm exercise preference trial on adherence and clinical outcomes compared to a similar 2-arm RCT in men with prostate cancer (PC).MethodsThis was a two-arm preference-based trial of group-based training (GROUP) or home-based training (HOME). PC survivors on androgen deprivation therapy (ADT) who declined randomization to the RCT but chose to participate in a preference trial were recruited in four Canadian centers. All study participants engaged in aerobic and resistance training, 4-5 days weekly for 6 months, aiming for 150 minutes/week of moderate-to-vigorous physical activity. The primary outcomes were changes from baseline to 6 months in fatigue and functional endurance. Secondary outcomes were quality of life, physical fitness, body composition, blood markers, and adherence. Linear mixed models were used to assess the effects of HOME versus GROUP on primary outcomes. In pooled preference and RCT data, the selection effect (i.e., difference between those who were and were not willing to be randomized) and treatment effect (i.e., difference between GROUP and HOME) were estimated using linear regression.Results and conclusionFifty-four participants (mean [SD] age, 70.2 [8.6] years) were enrolled (GROUP n=17; HOME n=37). Comparable effects on primary and secondary outcomes were observed following GROUP or HOME in the preference-based trial. Adherence was similar between preference and RCT participants. However, attrition was higher in the RCT (50.0% vs. 27.8%, p= 0.04). Compared to GROUP, HOME was more effective in ameliorating fatigue (mean difference: +5.2, 95%CI=1.3 to 9.3 p=0.01) in pooled preference and RCT data. A preference-based trial results in comparable observed effects on clinical outcomes and adherence and lower attrition compared with a RCT of the same exercise interventions in PC survivors on ADT. Given the appeals of preference-based trials to study participants, additional studies are warranted.Clinical trial registrationclinicaltrials.gov, identifier (NCT03335631).https://www.frontiersin.org/articles/10.3389/fonc.2022.1033229/fullprostate cancerandrogen deprivationgroup exercisehome-based exercisefatiguefunctional endurance |
| spellingShingle | Shabbir M. H. Alibhai Shabbir M. H. Alibhai Efthymios Papadopoulos Sara Durbano George Tomlinson George Tomlinson Daniel Santa Mina Paul Ritvo Catherine M. Sabiston Andrew G. Matthew James Chiarotto Souraya Sidani S. Nicole Culos-Reed S. Nicole Culos-Reed Preference-based versus randomized controlled trial in prostate cancer survivors: Comparison of recruitment, adherence, attrition, and clinical outcomes Frontiers in Oncology prostate cancer androgen deprivation group exercise home-based exercise fatigue functional endurance |
| title | Preference-based versus randomized controlled trial in prostate cancer survivors: Comparison of recruitment, adherence, attrition, and clinical outcomes |
| title_full | Preference-based versus randomized controlled trial in prostate cancer survivors: Comparison of recruitment, adherence, attrition, and clinical outcomes |
| title_fullStr | Preference-based versus randomized controlled trial in prostate cancer survivors: Comparison of recruitment, adherence, attrition, and clinical outcomes |
| title_full_unstemmed | Preference-based versus randomized controlled trial in prostate cancer survivors: Comparison of recruitment, adherence, attrition, and clinical outcomes |
| title_short | Preference-based versus randomized controlled trial in prostate cancer survivors: Comparison of recruitment, adherence, attrition, and clinical outcomes |
| title_sort | preference based versus randomized controlled trial in prostate cancer survivors comparison of recruitment adherence attrition and clinical outcomes |
| topic | prostate cancer androgen deprivation group exercise home-based exercise fatigue functional endurance |
| url | https://www.frontiersin.org/articles/10.3389/fonc.2022.1033229/full |
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