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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Linguistically and Culturally Tailored Information
Cognitive-Behavioral Stress Management
Sponsored by
University of Maryland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring Breast Cancer, Korean Americans, Survivorship, Quality of Life, Coping Skills, Perceived Stress

Eligibility Criteria

25 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    Standard Intervention

    Enhanced Intervention

    Arm Description

    The standard intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship.

    The enhanced intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship as well as cognitive-behavioral stress management.

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Cancer Behavior Inventory- Brief Version (CBI-B)
    Perceived Stress Scale (PSS)
    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.

    Full Information

    First Posted
    May 10, 2016
    Last Updated
    July 7, 2016
    Sponsor
    University of Maryland
    Collaborators
    National Cancer Institute (NCI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02770469
    Brief Title
    Culturally Tailored Educational and Support Program to Increase Quality of Life Among Korean Breast Cancer Survivors
    Acronym
    TOGETHER
    Official Title
    Behavioral Intervention to Reduce Breast Cancer Disparity Among Underserved Koreans
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2014 (undefined)
    Primary Completion Date
    June 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Maryland
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breast Cancer
    Keywords
    Breast Cancer, Korean Americans, Survivorship, Quality of Life, Coping Skills, Perceived Stress

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    86 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Intervention
    Arm Type
    Active Comparator
    Arm Description
    The standard intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship.
    Arm Title
    Enhanced Intervention
    Arm Type
    Experimental
    Arm Description
    The enhanced intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship as well as cognitive-behavioral stress management.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Linguistically and Culturally Tailored Information
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Cognitive-Behavioral Stress Management
    Intervention Description
    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 Measure Information:
    Title
    Functional Assessment of Cancer Therapy-Breast (FACT-B)
    Time Frame
    changes in quality of life during baseline, 7 weeks, and 14 weeks
    Secondary Outcome Measure Information:
    Title
    Cancer Behavior Inventory- Brief Version (CBI-B)
    Time Frame
    changes in self-efficacy for coping with cancer during baseline, 7 weeks, and 14 weeks
    Title
    Perceived Stress Scale (PSS)
    Time Frame
    changes in stress during baseline, 7 weeks, and 14 weeks
    Title
    Additional items to assess improvement in skills/knowledge covered by the intervention program
    Description
    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.
    Time Frame
    changes in responses during baseline, 7 weeks, and 14 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Sunmin Lee, ScD
    Organizational Affiliation
    University of Maryland School of Public Health
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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