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

 Soo Hyun Kim  ;  Yu Hyeon Choe  ;  Ah Reum Han  ;  Gwui Jeong Yeon  ;  Gyeong Hee Lee  ;  Bo Gyeong Lee  ;  Young Up Cho  ;  Seho Park  ;  Moon Hee Lee 
 BMC CANCER, Vol.20(1) : 367, 2020-05 
Journal Title
Issue Date
Adult ; Aged ; Aged, 80 and over ; Breast Neoplasms / psychology* ; Breast Neoplasms / therapy* ; Cancer Survivors / psychology* ; Female ; Follow-Up Studies ; Humans ; Middle Aged ; Needs Assessment ; Prognosis ; Quality of Life ; Research Design ; Self Efficacy ; Self-Management / methods* ; Self-Management / psychology ; Surveys and Questionnaires
Breast cancer ; Empowerment ; Health-related quality of life ; Randomized controlled trial ; Self-efficacy ; Self-management
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.
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1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Park, Se Ho(박세호) ORCID logo https://orcid.org/0000-0001-8089-2755
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