Preference-based versus randomized controlled trial in prostate cancer survivors: Comparison of recruitment, adherence, attrition, and clinical outcomes
Bibliographic record
Abstract
Introduction Patients’ 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. Objective We 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). Methods This 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 conclusion Fifty-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 registration clinicaltrials.gov , identifier (NCT03335631).
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.064 | 0.093 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.010 | 0.008 |
| Bibliometrics | 0.002 | 0.002 |
| Science and technology studies | 0.001 | 0.003 |
| Scholarly communication | 0.002 | 0.003 |
| Open science | 0.002 | 0.001 |
| Research integrity | 0.005 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".