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.