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

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ClinicalTrials.gov Identifier: NCT02770469
Recruitment Status : Completed
First Posted : May 12, 2016
Last Update Posted : July 11, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Maryland

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Linguistically and Culturally Tailored Information Behavioral: Cognitive-Behavioral Stress Management Not Applicable

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  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Behavioral Intervention to Reduce Breast Cancer Disparity Among Underserved Koreans
Study Start Date : February 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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.




Primary Outcome Measures :
  1. Functional Assessment of Cancer Therapy-Breast (FACT-B) [ Time Frame: changes in quality of life during baseline, 7 weeks, and 14 weeks ]

Secondary Outcome Measures :
  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.



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Ages Eligible for Study:   25 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770469


Sponsors and Collaborators
University of Maryland
National Cancer Institute (NCI)
Investigators
Principal Investigator: Sunmin Lee, ScD University of Maryland School of Public Health

Additional Information:
Responsible Party: University of Maryland
ClinicalTrials.gov Identifier: NCT02770469     History of Changes
Other Study ID Numbers: R21CA178471 ( U.S. NIH Grant/Contract )
First Posted: May 12, 2016    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

Keywords provided by University of Maryland:
Breast Cancer
Korean Americans
Survivorship
Quality of Life
Coping Skills
Perceived Stress

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases