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OpenTrials
Completed

NCT Number: NCT02770469

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

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.

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Key information

Age range

25 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Linguistically and Culturally Tailored Information

Behavioral

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

Behavioral

Participants learned and practiced skills related to mindfulness, relaxation, stress reduction, rational thinking, improving coping, enhancing social support, anger management, and assertiveness training.

Primary outcomes

  1. Functional Assessment of Cancer Therapy-Breast (FACT-B)

    Time frame: changes in quality of life during baseline, 7 weeks, and 14 weeks

Secondary outcomes

  1. Cancer Behavior Inventory- Brief Version (CBI-B)

    Time frame: changes in self-efficacy for coping with cancer during baseline, 7 weeks, and 14 weeks

  2. Perceived Stress Scale (PSS)

    Time frame: changes in stress during baseline, 7 weeks, and 14 weeks

  3. 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.

Sponsors and collaborators

Lead sponsor

University of Maryland, College Park

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Behavioral Intervention to Reduce Breast Cancer Disparity Among Underserved Koreans

Acronym: TOGETHER

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
May 12, 2016
Registry last updated
Dec 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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