Breast CancerTOGETHERNCT02770469
Culturally Tailored Educational and Support Program to Increase Quality of Life Among Korean Breast Cancer Survivors
A study testing Linguistically and Culturally Tailored Information and Cognitive-Behavioral Stress Management in people with Breast Cancer, run by University of Maryland, College Park.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 85 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Linguistically and Culturally Tailored Information and Cognitive-Behavioral Stress Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to understand Korean
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Linguistically and Culturally Tailored Information, Cognitive-Behavioral Stress Management
- Keywords
- Breast Cancer, Korean Americans, Survivorship, Quality of Life, Coping Skills, Perceived Stress
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linguistically and Culturally Tailored InformationBehavioural
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 ManagementBehavioural
Participants learned and practiced skills related to mindfulness, relaxation, stress reduction, rational thinking, improving coping, enhancing social support, anger management, and assertiveness training.
| Study group | Role | What they receive |
|---|---|---|
| Standard Intervention | Active comparator | The standard intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship. Receives: Behavioral: Linguistically and Culturally Tailored Information |
| Enhanced Intervention | Experimental | The enhanced intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship as well as cognitive-behavioral stress management. Receives: Behavioral: Linguistically and Culturally Tailored Information; Behavioral: Cognitive-Behavioral Stress Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Measured: changes in quality of life during baseline, 7 weeks, and 14 weeks
Secondary outcomes (3)
Cancer Behavior Inventory- Brief Version (CBI-B)
Measured: changes in self-efficacy for coping with cancer during baseline, 7 weeks, and 14 weeks
Perceived Stress Scale (PSS)
Measured: changes in stress during baseline, 7 weeks, and 14 weeks
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.
Measured: changes in responses during baseline, 7 weeks, and 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2016 (estimated)
- Study startFeb 2014
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sunmin Lee, ScD, Principal investigator, University of Maryland School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02770469
- Sponsor's protocol ID
- R21CA178471
- Acronym
- TOGETHER
- Status last verified
- Dec 2023
- First submitted
- 10 May 2016
- Last updated
- 27 Dec 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Intervention to Reduce Breast Cancer Disparity Among Underserved Koreans
- ClinicalTrials.gov ID
- NCT02770469
- Acronym / sponsor ID
- TOGETHER / R21CA178471
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Korean Americans, Survivorship, Quality of Life, Coping Skills, Perceived Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Intervention | Active comparator | Behavioral: Linguistically and Culturally Tailored InformationThe standard intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship. |
| Enhanced Intervention | Experimental | Behavioral: Linguistically and Culturally Tailored Information, Behavioral: Cognitive-Behavioral Stress ManagementThe enhanced intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship as well as cognitive-behavioral stress management. |
Who may qualify
- Ages
- 25 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Unable to understand Korean
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linguistically and Culturally Tailored InformationParticipants 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. | Behavioural | Enhanced Intervention, Standard Intervention |
| Cognitive-Behavioral Stress ManagementParticipants learned and practiced skills related to mindfulness, relaxation, stress reduction, rational thinking, improving coping, enhancing social support, anger management, and assertiveness training. | Behavioural | Enhanced Intervention |
Primary outcome
Functional Assessment of Cancer Therapy-Breast (FACT-B)
Time frame: changes in quality of life during baseline, 7 weeks, and 14 weeks
3 secondary outcomes
Cancer Behavior Inventory- Brief Version (CBI-B)
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- TOGETHER Program websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunmin Lee, ScD principal investigator
University of Maryland School of Public Health
Questions about this trial
What is this clinical trial studying?
A study testing Linguistically and Culturally Tailored Information and Cognitive-Behavioral Stress Management in people with Breast Cancer, run by University of Maryland, College Park.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Assessment of Cancer Therapy-Breast (FACT-B) (time frame: changes in quality of life during baseline, 7 weeks, and 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2023.