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

Breast Cancer Clinical Trial

— TOGETHER  

Official title:

Behavioral Intervention to Reduce Breast Cancer Disparity Among Underserved Koreans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02770469
• Other study ID #: R21CA178471
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: June 2016

Study information

• Verified date: December 2023
• Source: University of Maryland, College Park
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 85 Years

Eligibility

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

Exclusion Criteria:

• Unable to understand Korean

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Behavioral:
• Linguistically and Culturally Tailored Information
Participants received linguistically and culturally tailored information on diet and nutrition, physical activity, managing treatment side effects, follow-up care plans, complementary and alternative medicine, reducing environmental exposure to estrogen, navigating cancer-related financial issues, family history, body image, sexuality, and advances in breast cancer research.
• Cognitive-Behavioral Stress Management
Participants learned and practiced skills related to mindfulness, relaxation, stress reduction, rational thinking, improving coping, enhancing social support, anger management, and assertiveness training.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, College Park	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Assessment of Cancer Therapy-Breast (FACT-B)		changes in quality of life during baseline, 7 weeks, and 14 weeks
Secondary	Cancer Behavior Inventory- Brief Version (CBI-B)		changes in self-efficacy for coping with cancer during baseline, 7 weeks, and 14 weeks
Secondary	Perceived Stress Scale (PSS)		changes in stress during baseline, 7 weeks, and 14 weeks
Secondary	Additional items to assess improvement in skills/knowledge covered by the intervention program	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.	changes in responses during baseline, 7 weeks, and 14 weeks

External Links

•   TOGETHER Program website