Culturally Tailored Educational and Support Program to Increase Quality of Life Among Korean Breast Cancer Survivors (TOGETHER)
December 20, 2023 updated by: University of Maryland, College Park
Behavioral Intervention to Reduce Breast Cancer Disparity Among Underserved Koreans
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.
Study Overview
Status
Completed
Conditions
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 Type
Interventional
Enrollment (Actual)
86
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Standard Intervention
The standard intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship.
|
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.
|
|
Experimental: Enhanced Intervention
The enhanced intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship as well as cognitive-behavioral stress management.
|
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.
Participants learned and practiced skills related to mindfulness, relaxation, stress reduction, rational thinking, improving coping, enhancing social support, anger management, and assertiveness training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Time Frame: changes in quality of life during baseline, 7 weeks, and 14 weeks
|
changes in quality of life during baseline, 7 weeks, and 14 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cancer Behavior Inventory- Brief Version (CBI-B)
Time Frame: changes in self-efficacy for coping with cancer during baseline, 7 weeks, and 14 weeks
|
changes in self-efficacy for coping with cancer during baseline, 7 weeks, and 14 weeks
|
|
|
Perceived Stress Scale (PSS)
Time Frame: changes in stress during baseline, 7 weeks, and 14 weeks
|
changes in stress during baseline, 7 weeks, and 14 weeks
|
|
|
Additional items to assess improvement in skills/knowledge covered by the intervention program
Time Frame: 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.
|
changes in responses during baseline, 7 weeks, and 14 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Sunmin Lee, ScD, University of Maryland School of Public Health
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2014
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
May 10, 2016
First Submitted That Met QC Criteria
May 11, 2016
First Posted (Estimated)
May 12, 2016
Study Record Updates
Last Update Posted (Actual)
December 27, 2023
Last Update Submitted That Met QC Criteria
December 20, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21CA178471 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.