Feasibility and Preliminary Outcomes of an Education Program to Promote Self-regulation Among Patients With Gastrointestinal Tract Cancer Newly Taking Oral Anticancer Agents: A Pilot Randomized Controlled Trial.

Background: Suboptimal adherence to oral anticancer agents (OAAs) reduces therapeutic benefits among patients with gastrointestinal tract cancer. Self-regulation is an important mechanism to foster behavioral change, but little is known about how to utilize this mechanism to enhance adherence.

Objective: The aim of this study was to evaluate the feasibility, acceptability, and preliminary outcomes of an education program to promote self-regulation in managing adherence to OAAs.

Methods: A 2-arm pilot randomized controlled trial was adopted. Twenty-four participants were randomized to the control or intervention group with a 1:1 ratio. The control group received usual care. The intervention group received usual care and 4 sessions of education to promote self-regulation. Feasibility, acceptability, and preliminary outcomes were evaluated using descriptive statistics and Cohen's d.

Results: The consent and attrition rates were 64.86% and 8.33%, respectively. Most (83.33%) participants in the intervention group finished all education sessions. They were satisfied with the educational content and perceived the program as helpful. A favorable trend of better adherence (adherence rate: 90.91%), more self-management behaviors (Cohen's d = 0.915), less negative illness perceptions (Cohen's d = -0.714), higher medication self-efficacy (Cohen's d = 0.431), and necessity beliefs (Cohen's d = 0.451) was found in the intervention group.

Conclusions: The education program is considered feasible and acceptable. A full-scale randomized control trial is needed to explore its effectiveness in a larger sample.

Implications for practice: This education program to promote self-regulation is promising to support adherence to OAAs, self-management behaviors, favorable illness perceptions, and medication self-efficacy.