- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01632956
Developing Culturally-Tailored Information-Based Support Groups for Chinese Immigrants With Breast Cancer
February 5, 2014 updated by: Memorial Sloan Kettering Cancer Center
Developing Culturally-Tailored Information-Based Support Groups for Chinese Immigrants With Breast Cancer: A Pilot Study
There are few breast cancer support groups that focus on the specific needs of Chinese women.
The purpose of this study is to learn about two different ways of providing support groups to help women of Chinese descent cope with the difficulties of a diagnosis of breast cancer and its treatment.
The investigators want to learn about how best to support Chinese women with breast cancer by providing two different types of groups: an in-person support group and a virtual (online/phone) support group.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Observational
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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New York
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Jamaica, New York, United States, 11432
- Queens Cancer Center of Queens Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Recruitment will be conducted by the MSKCC Research Study Assistant (RSA) with the assistance of the treatment team and community partners.
Patients of MSKCC and QCC will be approached in clinic waiting rooms by the RSA.
ACS Asian Initiatives and the Charles B Wang Community Health Center are referral sites for this study.
Description
Inclusion Criteria:
- Female
- Non-US born
- Resident in the US < 20 years
- Of Chinese descent
- Age 21 years through 80 years
- Language spoken: Mandarin
Diagnosis of breast cancer within 3 months prior to recruitment
*Not required that breast cancer is the patients' first and/or only cancer diagnosis
- Currently receiving cancer treatment;
- Will be living continuously in the US for the next year
- Has a telephone that he/she is willing to use for the study
Exclusion Criteria:
- Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection
- Another household member is already enrolled.
- Prior participation in a cancer support group
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
in-person support group
This is a 1 year pilot study of the feasibility of participation in both in-person and virtual information-based, culturally tailored support groups for Chinese breast cancer patients.
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Each support group will consist of 12 sessions.
Thirty-two breast cancer patients of Chinese descent will be recruited to participate in the support groups (16 in the inperson groups and 16 in the virtual groups).
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virtual support group
This is a 1 year pilot study of the feasibility of participation in both in-person and virtual information-based, culturally tailored support groups for Chinese breast cancer patients.
|
Each support group will consist of 12 sessions.
Thirty-two breast cancer patients of Chinese descent will be recruited to participate in the support groups (16 in the inperson groups and 16 in the virtual groups).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
feasibility
Time Frame: 1 year
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To pilot and evaluate the feasibility of information-based, culturally-tailored in-person and virtual support groups for Chinese patients with breast cancer.
The feasibility of participation in the in-person and virtual support groups will be measured by documenting patient accrual to the pilot study and attendance at the support groups.
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1 year
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To compare the impact of participation
Time Frame: 1 year
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in the in-person versus virtual support groups on quality of life (QOL), pain, psychosocial outcomes (distress, depression, anxiety, self-efficacy in coping with cancer), and perceived social support.
These outcomes will be measured through a baseline and exit Outcomes Survey.
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1 year
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To assess satisfaction with the support groups
Time Frame: 1 year
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All participants will complete the Brief Support Group Survey at the end of each support meeting to assess satisfaction with and to provide feedback on the usefulness of the meeting and the information presented, ease of understanding and cultural appropriateness of the information, effectiveness of the facilitator, and suggestions for change or improvement.
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1 year
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To assess Internet use
Time Frame: 1 year
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among support group participants.
All patients approached for study participation will complete the Screening Tool, which includes questions related to Internet use.
The Screening Tool will be used for all eligible patients (patients refusing to participate will still be asked to complete the screening tool).
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1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jennifer Leng, MD, MPH, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Anticipated)
June 1, 2014
Study Completion (Anticipated)
June 1, 2014
Study Registration Dates
First Submitted
June 29, 2012
First Submitted That Met QC Criteria
July 3, 2012
First Posted (Estimate)
July 4, 2012
Study Record Updates
Last Update Posted (Estimate)
February 6, 2014
Last Update Submitted That Met QC Criteria
February 5, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-105
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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