Ignite Creation Date:
2025-12-24 @ 11:47 PM
Ignite Modification Date:
2026-02-20 @ 6:34 PM
Study NCT ID:
NCT04685551
Status:
WITHDRAWN
Last Update Posted:
2022-07-26
First Post:
2020-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Survivorship Among Minority Cancer Dyads
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D000084802', 'term': 'Caregiver Burden'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'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': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006295', 'term': 'Health Resources'}], 'ancestors': [{'id': 'D006285', 'term': 'Health Planning'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study not funded', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-22', 'studyFirstSubmitDate': '2020-12-22', 'studyFirstSubmitQcDate': '2020-12-22', 'lastUpdatePostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in psychosocial well-being using the Quality of Life: Short Form Health Survey and the Center for Epidemiologic Studies Depression Scale', 'timeFrame': '3 months', 'description': 'By comparison from baseline to post-intervention, there will be a 25% increase in the psychosocial well-being among study participants.'}, {'measure': 'Reduction of barriers to symptom management Using the Symptom Distress Scale survey', 'timeFrame': '3 months', 'description': 'By comparison from baseline to post-intervention, there will be a 25% decrease in the barriers to symptom management among study participants.'}, {'measure': '3. Decrease in unmet needs Using the Barriers to Follow-Up Care Survey and Cancer Survivors Unmet Needs instrument', 'timeFrame': '3 months', 'description': 'By comparison from baseline to post-intervention, there will be a 25% decrease in the unmet needs among study participants.'}, {'measure': 'Reduction in caregiver burden using the Caregiver reaction assessment (CRA) survey', 'timeFrame': '3 months', 'description': 'By comparison from baseline to post-intervention, there will be a 25% decrease in the caregiver burden among study participants.'}, {'measure': '5. Increase knowledge and utilization of supportive services using the Medical Outcomes Study Social Support Survey', 'timeFrame': '3 months', 'description': 'By comparison from baseline to post-intervention, there will be a 25% increase in the knowledge and utilization of supportive services among study participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer', 'Breast Cancer', 'Colon Cancer', 'Caregiver Burnout', 'Lung Cancer']}, 'descriptionModule': {'briefSummary': 'This proposed intervention centers on improving survivorship outcomes among African American and Latinx cancer survivor and caregiver dyads. As a result, there will be four major outcomes. First, as a result of partnership with minority social institutions (e.g. faith leaders), we will develop an in-depth culturally sensitive curriculum and survivorship care plan for Cancer Survivorship and Caregiver Leaders Aimed for Minority Populations (CSC LAMPs). Second, we will increase knowledge and skills by evaluating a comprehensive cancer survivorship training program designed for underserved health professional students. Third, the implementation of this program will improve survivorship outcomes among African American and Latinx cancer survivors with advanced stage cancer and their caregivers. Lastly, this study will build sustainability for underserved minorities with the training of 30 future healthcare providers as a valuable community resource for improving cancer survivorship outcomes. The long-term outcomes of the CSC LAMPs program will generate workforce capacity and diversity in cancer-based clinical practice, research, and community advocacy for underserved minority cancer survivors and caregivers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Aim 1 Focus Group for Cancer Survivors and Caregivers:\n\nInclusion Criteria\n\n* Individuals ages 18 and older\n* identify as African American or Latinx\n* identify as a cancer survivor and/or caregiver\n* speak and/or understand English\n\nExclusion Criteria\n\n* individuals ages 17 years or younger\n* does not identify as African American or Latinx\n* unable to speak or understand English\n* does not identify as a cancer survivor or caregiver\n\nAim 1 Focus Group for Oncology Healthcare Providers:\n\nInclusion Criteria\n\n* Individuals ages 18 and older\n* identify as a healthcare provider\n* provide care to cancer patients in current provider role\n* speak and/or understand English\n\nExclusion Criteria\n\n* individuals ages 17 years or younger\n* unable to speak or understand English\n* does not provide care to cancer patients\n* does not identify as a healthcare provider\n\nAim 2:\n\nInclusion Criteria\n\n* Individuals ages 18 and older\n* registered as a CDU student\n* speak and/or understand English\n* considered to be underserved, which include a) identifying as an underrepresented minority: Asian, Pacific Islander, African American, Hispanic, and Native American/Alaskan Native and/or b) from a medically underserved population (i.e. faced economic, cultural or linguistic barriers to health care)\n\nExclusion Criteria\n\n* individuals ages 17 years or younger\n* not registered as a CDU student\n* unable to speak or understand English\n* not considered to be underserved\n\nFor Aim 3:\n\nInclusion Criteria\n\n* cancer survivor with a participating caregiver\n* stage III or stage IV cancer diagnosis\n* breast, lung, or colorectal cancer diagnosis\n* identify as African American or Latinx\n* speak and/or understand English\n\nExclusion Criteria\n\n* individuals ages 17 years or younger\n* does not identify as African American or Latinx\n* unable to speak or understand English\n* does not identify as a cancer survivor\n* cancer survivor does not identify a caregiver\n* does not have a breast, lung, or colorectal cancer diagnosis\n* not diagnosed with a stage III or stage IV cancer diagnosis'}, 'identificationModule': {'nctId': 'NCT04685551', 'briefTitle': 'Improving Survivorship Among Minority Cancer Dyads', 'organization': {'class': 'OTHER', 'fullName': 'Charles Drew University of Medicine and Science'}, 'officialTitle': 'Improving Survivorship Outcomes for African American and Latinx Cancer Survivors and Caregiver Dyads Through A Culturally Based Training Program for Underserved Health Professional Students', 'orgStudyIdInfo': {'id': 'CancerDyads'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Survivorship Management among African American and Latinx Cancer Dyads', 'description': 'This arm will implement a "one group pre-test and posttest" design to improve health outcomes of African American and Latinx cancer survivors and caregivers in collaboration with health professional students trained as Cancer Survivorship and Caregiver Leaders Aimed for Minority Populations (CSC LAMPs).', 'interventionNames': ['Behavioral: Change in knowledge, motivation, skills, and resources']}], 'interventions': [{'name': 'Change in knowledge, motivation, skills, and resources', 'type': 'BEHAVIORAL', 'description': 'Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to improve survivorship outcomes.', 'armGroupLabels': ['Survivorship Management among African American and Latinx Cancer Dyads']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90059', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Charles R. Drew University of Medicine & Science', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Sharon Cobb', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charles R. Drew University of Medicine & Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Charles Drew University of Medicine and Science', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}