Ignite Creation Date:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-27 @ 6:28 AM
Study NCT ID:
NCT02690766
Status:
COMPLETED
Last Update Posted:
2023-05-16
First Post:
2016-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Translating Healthy Lifestyle Interventions for Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-12', 'studyFirstSubmitDate': '2016-02-18', 'studyFirstSubmitQcDate': '2016-02-18', 'lastUpdatePostDateStruct': {'date': '2023-05-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Body Weight', 'timeFrame': 'Week 0 and 16', 'description': 'Body weight in pounds will be measured on a digital scale to assess change in body weight over the 16-week intervention period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cancer', 'Breast Cancer', 'Endometrial cancer,', 'Type 2 Diabetes'], 'conditions': ['Diabetes Mellitus, Non-Insulin-Dependent', 'Breast Cancer', 'Endometrial Cancer']}, 'descriptionModule': {'briefSummary': 'Investigators proposed to refine and test the feasibility and acceptability of a 4-month multi-modal lifestyle intervention in African American female breast or endometrial cancer survivors diagnosed with type 2 diabetes.', 'detailedDescription': "Recent systematic reviews and meta-analyses of cohort studies show that physical activity can reduce mortality and morbidity in diabetes and obesity-related cancers. Yet, there have been few efforts to promote physical activity within the context of female cancer survivorship, particularly among women with diabetes. In response, investigators proposed to refine and test the feasibility and acceptability of a 4-month multi-modal lifestyle intervention in African Americans (AA) with diabetes and who are breast or endometrial cancer survivors. This web-based, lifestyle intervention, coupled with coaching calls and in-person exercise sessions, may be an effective way to promote physical activity and healthy survivorship. The primary goal is for participants to participate in 30 minutes of moderate-to-vigorous physical activity five times a week. The investigators' aims : i) refine a theory-driven healthy lifestyle intervention, that is delivered via computer technologies and periodic in-person group exercise sessions with appropriate content, literacy demand and graphics, ii) assess the preliminary effects of the intervention on the primary outcome of level of moderate to vigorous physical activity (MVPA), as measured by accelerometry; weight, glycosylated hemaglobin and evaluate the effect of eating behaviors, wellbeing/functioning (quality of life, depressive symptoms, self-efficacy), compliance/adherence to protocol and acceptability on response to the intervention."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* African American women, ages 30\n* No evidence of pregnancy, as evidenced by negative urine pregnancy test.\n* Diagnosed with type 2 diabetes by their provider\n* Diagnosed with Stage I-III breast or endometrial cancer\n* Completed treatment for breast or endometrial cancer at least 4 months and no more 5 years ago English-speaking\n* Agree to participate in all aspects of the semi-structured interview (Aim 1)\n* Agree to participate in all aspects of the feasibility study, including group sessions (Aim 2)\n* Access to the internet via phone or computer\n* Access to a working phone for personal use\n\nExclusion Criteria:\n\n* Non-English speaking\n* Recent epilepsy, cardiac event or stroke in last 6 months,special nutritional needs (e.g. current evidence of malignancy; HIV)\n* History of epilepsy, cardiac event or stroke within the last year\n* Known diagnosis of HIV\n* Known new malignancy\n* Less than 4 months or more than 2 years post treatment of Stage I-III breast or endometrial cancer.\n* No diagnosis of type 2 diabetes\n* No self-report of African American race/ethnicity\n* No access to a phone for personal use\n* No access to the internet via computer or mobile phone'}, 'identificationModule': {'nctId': 'NCT02690766', 'briefTitle': 'Translating Healthy Lifestyle Interventions for Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Translating Healthy Lifestyle Interventions for Breast and Endometrial Cancer Survivors With Diabetes', 'orgStudyIdInfo': {'id': '15-0162'}, 'secondaryIdInfos': [{'id': 'P30DK093002', 'link': 'https://reporter.nih.gov/quickSearch/P30DK093002', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Physical Activity Group', 'description': "The Success Study's Standard Behavioral Weight Change Intervention consists of 75 minute group sessions held monthly which include 30 minutes of physical activity with a licensed Physical Activity Instructor. Web Lessons that include information on Physical Activity, Nutrition and Healthy Behaviors will also be provided to participants on the study's website.", 'interventionNames': ['Behavioral: Standard Behavioral Weight Change Intervention']}], 'interventions': [{'name': 'Standard Behavioral Weight Change Intervention', 'type': 'BEHAVIORAL', 'description': "Participants enrolled in Phase 2 of the study will meet once a month for 75 minutes over the course of 4 months. Within this 75 minutes, they will complete 25 minutes of physical activity with a licensed physical activity instructor that is very experienced with working with this population, review and discuss various topics/lessons that relate to diabetes, nutrition, survivorship and physical activity with the study's interventionist and Group Leader", 'armGroupLabels': ['Physical Activity Group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Wanda Nicholson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}