- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07499089
Together-Breast Cancer Support Platform (Together)
"Together": A Bilingual Online Platform Support Intervention Project for Korean Breast Cancer Survivors
The goal of this study is to evaluate the acceptability and engagement of a culturally tailored online peer-support program for Korean speaking breast cancer patients and survivors. The main questions it aims to answer are: 1) Is the peer-support program acceptable and sustainable in terms of engagement between mentors and mentees over a 12-week period? 2) Does participation in the program improve quality of life, psychological well-being (including anxiety and depression), and perceived social support?
Participants will include Korean speaking breast cancer survivors (mentors) and patients currently undergoing treatment (mentees). After enrollment and matching based on screening information, participants will engage in peer-support interactions through an online platform for 12 weeks. Surveys will be administered at baseline, mid-point, post-intervention, and optional 6-month follow-up to assess outcomes.
Study Overview
Status
Conditions
Detailed Description
This study evaluates the acceptability and engagement of a culturally tailored online peer-support program for Korean speaking breast cancer patients and survivors, as well as its potential impact on psychosocial outcomes.
A total of 24 participants will be enrolled, including 8 mentors (breast cancer survivors diagnosed at least two years prior who have completed active treatment or are on long-term maintenance therapy) and 16 mentees (patients currently undergoing treatment).
Participants will be recruited through community outreach using study flyers with a QR code that links to an online eligibility screener. Individuals who complete the screener will be contacted by the study coordinator to confirm eligibility and complete the informed consent process prior to enrollment.
Mentors and mentees will be matched based on information collected from the screener, including demographic and clinical characteristics such as age group and cancer stage at diagnosis. Each mentor may be matched with up to two mentees.
Mentors will complete a structured training program prior to participation. All participants will engage in peer-support interactions through an online platform over a 12-week period, with a minimum expectation of at least one bidirectional interaction per week.
Data will be collected using REDCap. Participants will complete surveys at baseline, mid-intervention (weeks 4-5), and post-intervention (weeks 12-13), with an optional follow-up survey at 6 months.
Outcome measures include engagement metrics, quality of life, psychological well-being (including anxiety and depression), and perceived social support.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Min Jung Sung, BA
- Phone Number: 424-315-0709
- Email: minjung.sung@cshs.org
Study Locations
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California
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Los Angeles, California, United States, 90048
- Cedars Siani Cancer
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Contact:
- Min Jung Sung, BA
- Phone Number: 424-315-0709
- Email: minjung.sung@cshs.org
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Mentors:
- Age ≥ 18 years
- Self-identify as Korean
- Able to read, write, and speak both Korean and English
- Diagnosed with breast cancer ≥ 2 years prior to enrollment
- Completed active treatment or currently on long-term maintenance therapy
- Access to a smartphone, computer, or similar device compatible with the study platform
- Willing to participate for at least 3 months
- Willing to complete required training and surveys
Mentees:
- Age ≥ 18 years
- Self-identify as Korean
- Able to read, write, and speak Korean
- Diagnosed with breast cancer
- Currently receiving treatment (e.g., chemotherapy, radiation therapy, recent surgery, or endocrine therapy)
- Access to a smartphone, computer, or similar device compatible with the study platform
- Willing to participate for at least 3 months
- Willing to complete required surveys
Exclusion Criteria:
- Individuals who do not meet the inclusion criteria
- Individuals unable to use the online platform or required technology
- Individuals deemed non-compliant or inappropriate for participation based on investigator judgment (e.g., inability to complete study procedures)
- Mentees diagnosed with ductal carcinoma in situ (DCIS)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Mentors
Korean breast cancer survivors who complete mentor training and provide peer support to matched mentees through the Together online platform.
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Mentees
Korean breast cancer patients currently receiving treatment who are matched with trained mentors and participate in peer-support interactions through the Together online platform.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Feasibility of peer-support platform engagement
Time Frame: Week 1 to Week 12
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Feasibility is defined as the proportion of mentor-mentee pairs achieving at least one bidirectional interaction per week for at least 8 out of 12 weeks during the study period.
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Week 1 to Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in quality of life (FACT-B score)
Time Frame: Baseline to Week 12
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Quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire, which includes physical, social/family, emotional, and functional well-being domains.
|
Baseline to Week 12
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Change in social/family well-being (FACT-B social/family subscale)
Time Frame: Baseline to Week 12
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Social/family well-being will be assessed using the social/family well-being subscale of the FACT-B questionnaire.
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Baseline to Week 12
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Change in self-efficacy score
Time Frame: Baseline to Week 12
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Self-efficacy will be assessed using the self-efficacy scale included in the study questionnaire administered at baseline, mid-study, and post-study.
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Baseline to Week 12
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Study00003360
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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