Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-01-02 @ 5:38 PM
Study NCT ID:
NCT05243056
Status:
RECRUITING
Last Update Posted:
2025-08-01
First Post:
2021-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Quality of Life Intervention for Young African American Breast Cancer Survivors in Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D017410', 'term': 'Practice Guidelines as Topic'}, {'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D018479', 'term': 'Early Intervention, Educational'}, {'id': 'D004522', 'term': 'Educational Status'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D017408', 'term': 'Guidelines as Topic'}, {'id': 'D011785', 'term': 'Quality Assurance, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D002662', 'term': 'Child Health Services'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D011314', 'term': 'Preventive Health Services'}, {'id': 'D012959', 'term': 'Socioeconomic Factors'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2021-11-10', 'studyFirstSubmitQcDate': '2022-02-07', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of screen-eligible patients enrolled by consent', 'timeFrame': 'Up to 2 years', 'description': 'Descriptive statistics will be used to compute the proportion of screen-eligible patients enrolled by consent. Proportions will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate.'}, {'measure': 'Proportion of patients that complete all (seven) study contacts of intervention', 'timeFrame': 'Up to 2 years', 'description': 'Descriptive statistics will be used to compute proportion of patients that complete all (seven) study contacts of the intervention. Proportions will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate.'}, {'measure': 'Acceptability/Relevance of Intervention Sessions', 'timeFrame': 'Up to 2 years', 'description': "Will use qualitative interview to assess participants' perceptions of its acceptability/relevance of each of the six study contacts, using a Likert scale 0 to 10 with 0 being not at all satisfied/useful and 10 being completely satisfied/useful and an open ended question to understand why each score was provided. A composite score will be determined, where higher scores equate to higher acceptability/relevance. Descriptive statistics will be computed, along with 95% confidence intervals, to indicate the precision of the point estimate. Qualitative responses will be analyzed for content."}, {'measure': 'Participation in aspects of protocol', 'timeFrame': 'Up to 2 years', 'description': "Will use qualitative interview to assess participants' engagement by review of task completion to participate in aspects of the protocol (as an indicator of participant burden). There are a total of six sessions to complete and seven videos to review. Descriptive statistics will be used to compute the proportion of participant self-reported effectiveness of each intervention via the logs. Completion of tasks indicates greater willingness to participate."}, {'measure': 'Use of proposed self-management strategies and perceived effectiveness', 'timeFrame': 'Up to 2 years', 'description': "Will use qualitative interview to assess participants' engagement by review of use of proposed self-management strategies and their perceived effect on quality of life concerns using a Likert scale 0 to 10 with 0 being not at all effective and 10 being most effective. Descriptive statistics will be used to compute the proportion of participant self-reported effectiveness of each intervention via the logs. Qualitative responses will be analyzed for content."}, {'measure': 'Medical Outcomes Survey Short-Form (SF-36)', 'timeFrame': 'Baseline up to 1 month post-intervention', 'description': 'The SF-36 is a well-established measure of health status in cancer survivors. SF-36 includes one multi-item scale assessing eight health concepts: limitations in physical activity, social activity, role activity, bodily pain, psychological distress, limitations in social activity due to emotional distress, vitality, and general health perceptions. The scale ranges from 0-100. Higher scores indicate better functioning.\n\nWill use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.'}, {'measure': 'PROMIS Global Health10', 'timeFrame': 'Baseline up to 1 month post-intervention', 'description': 'The PROMIS Global Health 10 is a well-established measure of health status in cancer survivors. It assesses health and functioning including overall physical health, mental health, social health, pain, fatigue, and overall perceived quality of life. Higher scores indicate better functioning.\n\nWill use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.'}, {'measure': '(Functional Assessment of Chronic Illness Therapy Spiritual Well-Being (FACT-Sp 12)', 'timeFrame': 'Baseline up to 1 month post-intervention', 'description': 'The FACIT-SP-12 is the most widely used measure of spiritual well-being among those with cancer. Its subscales measure faith, meaning, and peace. Higher scores reflect higher well-being.\n\nWill use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.'}, {'measure': 'MOS Modified Social Support Survey', 'timeFrame': 'Baseline up to 1 month post-intervention', 'description': 'MOS assesses dimensions of social support with four functional support scales: emotional/informational, tangible, affectionate, and positive social interaction. The scale ranges from 0-100. Higher scores indicate greater social support.\n\nWill use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.'}, {'measure': 'COmprehensive Score for Financial Toxicity [COST]-Functional Assessment of Chronic Illness Therapy [FACIT]', 'timeFrame': 'Baseline up to 1 month post-intervention', 'description': 'COST-FACIT is a measure of financial toxicity and/or concerns related to cost of cancer care. Lower COST scores indicate higher financial toxicity.\n\nWill use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.'}, {'measure': 'PROMIS Applied Cognition - General Concerns short form (8- item)', 'timeFrame': 'Baseline up to 1 month post-intervention', 'description': 'This instrument measures working memory, speed of processing, and executive control of cognitive functioning. Higher scores reflect higher perceived cognitive functionality.\n\nWill use mixed-effects linear modeling for repeated measures to (a) test the fixed effect of time, intervention group, and their interaction; (b) derive within-group and between-group contrast estimates on the change from baseline at each follow-up.'}, {'measure': 'Perceived Stress', 'timeFrame': 'Baseline up to 1 month post-intervention', 'description': 'This instrument measures the perception of stress.\n\nThe PSS was designed for use in community samples with at least a junior high school education. The items are easy to understand, and the response alternatives are simple to grasp. This study will be using a short scale version of the scale, which uses four of the questions (2,4,5, and 10) of the questionnaire.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anatomic Stage I Breast Cancer AJCC v8', 'Anatomic Stage IA Breast Cancer AJCC v8', 'Anatomic Stage IB Breast Cancer AJCC v8', 'Anatomic Stage II Breast Cancer AJCC v8', 'Anatomic Stage IIA Breast Cancer AJCC v8', 'Anatomic Stage IIB Breast Cancer AJCC v8', 'Anatomic Stage III Breast Cancer AJCC v8', 'Anatomic Stage IIIA Breast Cancer AJCC v8', 'Anatomic Stage IIIB Breast Cancer AJCC v8', 'Anatomic Stage IIIC Breast Cancer AJCC v8', 'Prognostic Stage I Breast Cancer AJCC v8', 'Prognostic Stage IA Breast Cancer AJCC v8', 'Prognostic Stage IB Breast Cancer AJCC v8', 'Prognostic Stage II Breast Cancer AJCC v8', 'Prognostic Stage IIA Breast Cancer AJCC v8', 'Prognostic Stage IIB Breast Cancer AJCC v8', 'Prognostic Stage III Breast Cancer AJCC v8', 'Prognostic Stage IIIA Breast Cancer AJCC v8', 'Prognostic Stage IIIB Breast Cancer AJCC v8', 'Prognostic Stage IIIC Breast Cancer AJCC v8']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'The Jamesline'}]}, 'descriptionModule': {'briefSummary': 'This clinical trial studies the use of a quality of life intervention called Y-AMBIENT to help young African American with stage I-III breast cancer manage daily life. Y-AMBIENT is a four-month, telephone-based intervention that includes three themed education sessions with three follow-up sessions, written materials, and videos. The Y-AMBIENT intervention may improve quality of life and other health-related outcomes in young African American breast cancer survivors.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Evaluate feasibility and acceptability of Y-AMBIENT and enhanced usual care among young African American breast cancer survivors.\n\nII. Explore the degree to which the Y-AMBIENT versus (vs.) enhanced usual care affects preliminary health-related outcomes among young African American (AA survivors).\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM I (Y-AMBIENT): Patients receive three themed education sessions over 1 hour each, written materials, and videos at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss how they are doing and discuss any concerns that they are still managing at months 2, 3, and 4.\n\nARM II (ENHANCED USUAL CARE): Patients receive usual care at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss their chemotherapy regimen at months 2, 3, and 4.\n\nAfter completion of study, patients are followed up at 1 month.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Biologically born women\n* Self-identify as AA\n* Are aged 18 to 44 years on study entry\n* Are diagnosed with breast cancer stage I-III\n* Are in treatment with chemotherapy and/or radiation for stage I-III breast cancer at study entry\n* Are English- speaking\n* Have telephone and internet access\n\nExclusion Criteria:\n\n* Participation in formal survivorship navigation programs because they are associated with improved health- related outcomes, which could be a confounder'}, 'identificationModule': {'nctId': 'NCT05243056', 'briefTitle': 'A Quality of Life Intervention for Young African American Breast Cancer Survivors in Treatment', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Piloting Y-AMBIENT: A Quality of Life Intervention for Young African American Breast Cancer Survivors in Treatment', 'orgStudyIdInfo': {'id': 'IRB-300012132'}, 'secondaryIdInfos': [{'id': 'K08CA245208', 'link': 'https://reporter.nih.gov/quickSearch/K08CA245208', 'type': 'NIH'}, {'id': 'NCI-2021-02286', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (Y-AMBIENT)', 'description': 'Patients receive three themed education sessions over 1 hour each, written materials, and videos at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss how they are doing and discuss any concerns that they are still managing at months 2, 3, and 4.', 'interventionNames': ['Other: Educational Intervention', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm II (enhanced usual care)', 'description': 'Patients receive usual care at month 1. Patients also participate in 3, 20 minutes telephone reinforcement calls to discuss their chemotherapy regimen at months 2, 3, and 4.', 'interventionNames': ['Other: Best Practice', 'Other: Quality-of-Life Assessment', 'Other: Questionnaire Administration']}], 'interventions': [{'name': 'Best Practice', 'type': 'OTHER', 'otherNames': ['standard of care', 'standard therapy'], 'description': 'Receive enhanced usual care', 'armGroupLabels': ['Arm II (enhanced usual care)']}, {'name': 'Educational Intervention', 'type': 'OTHER', 'otherNames': ['Education for Intervention', 'Intervention by Education', 'Intervention through Education', 'Intervention, Educational'], 'description': 'Receive Y-AMBIENT', 'armGroupLabels': ['Arm I (Y-AMBIENT)']}, {'name': 'Quality-of-Life Assessment', 'type': 'OTHER', 'otherNames': ['Quality of Life Assessment'], 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (Y-AMBIENT)', 'Arm II (enhanced usual care)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (Y-AMBIENT)', 'Arm II (enhanced usual care)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Timiya Nolan', 'role': 'CONTACT', 'email': 'Nolan.261@osu.edu', 'phone': '614-292-4482'}, {'name': 'Timiya Nolan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'The Ohio State University Comprehensive Cancer Center', 'role': 'CONTACT', 'email': 'OSUCCCClinicaltrials@osumc.edu', 'phone': '800-293-5066'}], 'overallOfficials': [{'name': 'Timiya Nolan, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Timiya Nolan', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}