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

Intervention / Treatment

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.
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.
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.
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.
Behavioral: 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.

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.

Sponsor

University of Maryland, College Park

Collaborators

National Cancer Institute (NCI)

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

Keywords

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.

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