Alternatives for randomization in lifestyle intervention studies in cancer patients were not better than conventional randomization

Abstract

Objective: Assessing effects of lifestyle interventions in cancer patients has some specific challenges. Although randomization is urgently needed for evidence-based knowledge, sometimes it is difficult to apply conventional randomization (i.e., consent preceding randomization and intervention) in daily settings. Randomization before seeking consent was proposed by Zelen, and additional modifications were proposed since. We discuss four alternatives for conventional randomization: single and double randomized consent design, two-stage randomized consent design, and the design with consent to postponed information.

Study design and setting: We considered these designs when designing a study to assess the impact of physical activity on cancer-related fatigue and quality of life. We tested the modified Zelen design with consent to postponed information in a pilot. The design was chosen to prevent drop out of participants in the control group because of disappointment about the allocation.

Results: The result was a low overall participation rate most likely because of perceived lack of information by eligible patients and a relatively high dropout in the intervention group.

Conclusion: We conclude that the alternatives were not better than conventional randomization.