Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-01-05 @ 5:31 PM
Study NCT ID:
NCT02770469
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2016-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Culturally Tailored Educational and Support Program to Increase Quality of Life Among Korean Breast Cancer Survivors
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-20', 'studyFirstSubmitDate': '2016-05-10', 'studyFirstSubmitQcDate': '2016-05-11', 'lastUpdatePostDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Functional Assessment of Cancer Therapy-Breast (FACT-B)', 'timeFrame': 'changes in quality of life during baseline, 7 weeks, and 14 weeks'}], 'secondaryOutcomes': [{'measure': 'Cancer Behavior Inventory- Brief Version (CBI-B)', 'timeFrame': 'changes in self-efficacy for coping with cancer during baseline, 7 weeks, and 14 weeks'}, {'measure': 'Perceived Stress Scale (PSS)', 'timeFrame': 'changes in stress during baseline, 7 weeks, and 14 weeks'}, {'measure': 'Additional items to assess improvement in skills/knowledge covered by the intervention program', 'timeFrame': 'changes in responses during baseline, 7 weeks, and 14 weeks', '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.'}]}, 'conditionsModule': {'keywords': ['Breast Cancer', 'Korean Americans', 'Survivorship', 'Quality of Life', 'Coping Skills', 'Perceived Stress'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.togetherprogram.org/', 'label': 'TOGETHER Program website'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Living in Maryland, Northern Virginia, or the Washington D.C. metropolitan area\n* Have been diagnosed with breast cancer\n* Have had surgery, completed treatment within the last two years, or still receiving adjuvant therapies\n\nExclusion Criteria:\n\n* Unable to understand Korean'}, 'identificationModule': {'nctId': 'NCT02770469', 'acronym': 'TOGETHER', 'briefTitle': 'Culturally Tailored Educational and Support Program to Increase Quality of Life Among Korean Breast Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, College Park'}, 'officialTitle': 'Behavioral Intervention to Reduce Breast Cancer Disparity Among Underserved Koreans', 'orgStudyIdInfo': {'id': 'R21CA178471', 'link': 'https://reporter.nih.gov/quickSearch/R21CA178471', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard Intervention', 'description': 'The standard intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship.', 'interventionNames': ['Behavioral: Linguistically and Culturally Tailored Information']}, {'type': 'EXPERIMENTAL', 'label': 'Enhanced Intervention', 'description': 'The enhanced intervention group received linguistically and culturally tailored information regarding breast cancer and survivorship as well as cognitive-behavioral stress management.', 'interventionNames': ['Behavioral: Linguistically and Culturally Tailored Information', 'Behavioral: Cognitive-Behavioral Stress Management']}], 'interventions': [{'name': 'Linguistically and Culturally Tailored Information', 'type': 'BEHAVIORAL', '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.', 'armGroupLabels': ['Enhanced Intervention', 'Standard Intervention']}, {'name': 'Cognitive-Behavioral Stress Management', 'type': 'BEHAVIORAL', 'description': 'Participants learned and practiced skills related to mindfulness, relaxation, stress reduction, rational thinking, improving coping, enhancing social support, anger management, and assertiveness training.', 'armGroupLabels': ['Enhanced Intervention']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Sunmin Lee, ScD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Maryland School of Public Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, College Park', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}