Culturally Tailored Educational and Support Program to Increase Quality of Life Among Korean Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Behavioral: Linguistically and Culturally Tailored Information; Behavioral: Cognitive-Behavioral Stress Management

• Registration Number: NCT02770469
• Lead Sponsor: University of Maryland, College Park

Brief Summary

The objective of the TOGETHER (Together Overcome and Get Empowered Through Health Education and Relationships) program was to examine the effectiveness of one of the first linguistically and culturally tailored intervention programs to increase quality of life among Korean American breast cancer survivors.

Detailed Description

This study employed a randomized trial design, consisting of a standard and enhanced intervention group. Participants attended seven weekly sessions and one follow-up session that lasted for about 2 hours each. All sessions were conducted by two Korean female bilingual licensed clinical psychologists.

The specific aims of this study were to: (1) Implement and evaluate the effects of tailored intervention on perceived stress, coping and quality of life among Korean American breast cancer survivors; and (2) Conduct a process evaluation to assess the feasibility and fidelity of the intervention, which will provide data that can inform the development of future interventions.

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-11
• Study First Posted: 2016-05-12
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-20
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 86

Inclusion Criteria

• Living in Maryland, Northern Virginia, or the Washington D.C. metropolitan area
• Have been diagnosed with breast cancer
• Have had surgery, completed treatment within the last two years, or still receiving adjuvant therapies

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Exclusion Criteria

• Unable to understand Korean

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Intervention	Linguistically and Culturally Tailored Information	The standard intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship.
Enhanced Intervention	Cognitive-Behavioral Stress Management	The enhanced intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship as well as cognitive-behavioral stress management.
Enhanced Intervention	Linguistically and Culturally Tailored Information	The enhanced intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship as well as cognitive-behavioral stress management.

Primary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy-Breast (FACT-B)	changes in quality of life during baseline, 7 weeks, and 14 weeks

Secondary Outcome Measures

Name	Time	Method
Additional items to assess improvement in skills/knowledge covered by the intervention program	changes in responses during baseline, 7 weeks, and 14 weeks	Participants were asked 12 multiple choice items on coping with stress, utilizing social support, anger management, assertiveness, and communicating with healthcare providers as well as 1 open-ended item on how participants cope with stress. Multiple choice items were on a 5-point Likert scale ranging from never to very often.
Perceived Stress Scale (PSS)	changes in stress during baseline, 7 weeks, and 14 weeks
Cancer Behavior Inventory- Brief Version (CBI-B)	changes in self-efficacy for coping with cancer during baseline, 7 weeks, and 14 weeks