Preventing non-adherence and treating adherence failure are important to consider in designing community-based clinical trials. The approach and methods for managing adherence are vital. This paper describes a practical and theoretically-based strategy for managing adherence in a small cancer prevention trial with subjects (n = 40) taking a non-steroidal anti-inflammatory drug, piroxicam. Average daily pill intake adherence was exceptionally high (97.4%) as measured by self-report calendar. Thus, the generalized adherence enhancement approach used in this study may have been a related factor, although statistical model-testing was not possible in this small trial. The generalized intervention took into account factors such as the potential barriers and benefits of being in the study, self-efficacy and satisfaction with the participant/staff relationship. These and other theoretical variables were incorporated into an overall adherence strategy that is discussed.

This study identified participants' reasons for good, marginal or poor adherence, or withdrawing from community-based clinical studies using a dietary and/or drug intervention. Adults aged 48-75 years participated in one of three studies related to decreasing colon polyp recurrence. Qualitative data from progress notes (N = 675) and end-of-study evaluations (N = 87) were coded using constant comparative analysis with 100% content validity panel agreement. Most common reasons for non-adherence were barriers such as side-effects, interference with vacation plans, unrelated illness, forgetting and competing outside stressors. Participation motivators were benefits such as altruism, medical benefits, free service and staff rapport. Findings supported the Health Behavior in Cancer Prevention model-based approach to adherence interventions and provided directions for adherence promotion in future community-based clinical studies.