Design of a randomized controlled trial of a partnership-based, needs-tailored self-management support intervention for post-treatment breast cancer survivors

Abstract

Background Self-management is becoming essential for breast cancer survivors, but evidence about the effectiveness of self-management support (SMS) intervention is lacking. To address this issue, we developed a theory-based SMS intervention, the ‘EMPOWER’, aimed at empowering breast cancer survivors. Here we describe the rationale of the intervention and its development. Methods The conceptual framework of this study is the Chronic Care Model, which posits that SMS can influence patient-provider relationships and ultimately improve health outcomes. We will conduct a multi-center, 2-armed randomized controlled trial to assess the effectiveness of EMPOWER among post-treatment breast cancer survivors in South Korea. The trial will include 94 women who completed primary breast cancer treatment within the last 6 months. Participants will be randomly assigned to the intervention group or the wait-list control group (1:1). The intervention group will receive a 7-week partnership-based and needs-tailored SMS intervention via telephone counseling. The primary outcome is empowerment. The secondary outcomes include self-efficacy for post-treatment self-management behaviors, mental adjustment, psychological distress, and health-related quality of life (HRQOL). Data will be collected by self-reported questionnaire at baseline, post-intervention, and 3-month follow-up. Discussion We believe that the EMPOWER intervention could improve HRQOL of post-treatment breast cancer survivors by enhancing their empowerment. If found successful, it could aid clinicians engaged in the long-term care of breast cancer survivors. Trial registration Clinical Research Information Service, KCT0004794. Registered 5 March 2020.

Effects of a partnership‐based, needs‐tailored self‐management support intervention for post‐treatment breast cancer survivors: A randomized controlled trial

“…(Cronbach's alpha at baseline for the total score was 0.93 and ranged from 0.71 to 0.90 for the subscales.) We detailed the psychometric properties of the outcome measures elsewhere 23 …”

“…The trial was registered in the Korean Clinical Research Information Service (KCT0004794). A detailed study protocol has been published elsewhere 23 …”

“…In addition, telephone counselors met weekly to discuss intervention fidelity and to address any problems that arose in the group intervention being offered. More intervention details are described in our study protocol 23 …”

“…22 Recently, we developed partnErship-based, needs-tailored self-Management support Program fOr Women with breast cancER (EMPOWER), an SMS intervention based on the CCM that aims to enhance empowerment. 23 We assumed that improving patientprovider interactions would lead to improved health outcomes. We believe that this interaction may be facilitated via the partnershipbased properties of EMPOWER.…”

Development and psychometric testing of the lymphedema self-management support scale for breast cancer survivors

“… 13 Providing social support had the potential to enhance patients' self-efficacy and self-management capabilities. 47 Our results indicated that the scale had good predictive validity, as the total predictive effect of SMS on self-management behavior was 0.961 ( P < 0.001). Moreover, SMS directly predicted self-management behavior ( β = 0.827, P < 0.001), accounting for 86.1%, and also indirectly influenced self-management behavior through self-efficacy ( β = 0.134, P < 0.001), accounting for 13.9%.…”