Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2025-12-25 @ 9:21 PM
Study NCT ID:
NCT01632956
Status:
WITHDRAWN
Last Update Posted:
2014-02-06
First Post:
2012-06-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Developing Culturally-Tailored Information-Based Support Groups for Chinese Immigrants With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-02-05', 'studyFirstSubmitDate': '2012-06-29', 'studyFirstSubmitQcDate': '2012-07-03', 'lastUpdatePostDateStruct': {'date': '2014-02-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'feasibility', 'timeFrame': '1 year', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'To compare the impact of participation', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'To assess satisfaction with the support groups', 'timeFrame': '1 year', 'description': '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.'}, {'measure': 'To assess Internet use', 'timeFrame': '1 year', 'description': '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).'}]}, 'conditionsModule': {'keywords': ['Support Groups', 'Breast cancer', 'Mandarin speaking', '12-105'], 'conditions': ['Chinese Immigrants With Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/', 'label': 'Memorial Sloan-Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female\n* Non-US born\n* Resident in the US \\< 20 years\n* Of Chinese descent\n* Age 21 years through 80 years\n* Language spoken: Mandarin\n* Diagnosis of breast cancer within 3 months prior to recruitment\n\n \\*Not required that breast cancer is the patients' first and/or only cancer diagnosis\n* Currently receiving cancer treatment;\n* Will be living continuously in the US for the next year\n* Has a telephone that he/she is willing to use for the study\n\nExclusion Criteria:\n\n* Presence of cognitive impairment disorder (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection\n* Another household member is already enrolled.\n* Prior participation in a cancer support group"}, 'identificationModule': {'nctId': 'NCT01632956', 'briefTitle': 'Developing Culturally-Tailored Information-Based Support Groups for Chinese Immigrants With Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Developing Culturally-Tailored Information-Based Support Groups for Chinese Immigrants With Breast Cancer: A Pilot Study', 'orgStudyIdInfo': {'id': '12-105'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'in-person support group', 'description': '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.', 'interventionNames': ['Behavioral: in-person support group']}, {'label': 'virtual support group', 'description': '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.', 'interventionNames': ['Behavioral: virtual support group']}], 'interventions': [{'name': 'in-person support group', 'type': 'BEHAVIORAL', 'description': '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).', 'armGroupLabels': ['in-person support group']}, {'name': 'virtual support group', 'type': 'BEHAVIORAL', 'description': '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).', 'armGroupLabels': ['virtual support group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11432', 'city': 'Jamaica', 'state': 'New York', 'country': 'United States', 'facility': 'Queens Cancer Center of Queens Hospital', 'geoPoint': {'lat': 40.69149, 'lon': -73.80569}}], 'overallOfficials': [{'name': 'Jennifer Leng, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cancer Support Community', 'class': 'UNKNOWN'}, {'name': 'CHARLES B WANG COMMUNITY HEALTH CENTER', 'class': 'UNKNOWN'}, {'name': 'Queens Health Network', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}