Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT05379933
Status:
COMPLETED
Last Update Posted:
2023-01-20
First Post:
2022-05-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-19', 'studyFirstSubmitDate': '2022-05-13', 'studyFirstSubmitQcDate': '2022-05-13', 'lastUpdatePostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Who Agree to Participate (Acceptability)', 'timeFrame': '12 Months', 'description': 'The study will be deemed acceptable if at least 50% of eligible family caregivers agree to participate'}, {'measure': 'Percentage of Participants Who Provide Data (Feasibility)', 'timeFrame': '12 Months', 'description': 'The study will be deemed feasible if at least 75% of family caregivers who participate provide data for at least 50% of study days'}], 'secondaryOutcomes': [{'measure': 'Self Care Behaviors - Primary Efficacy', 'timeFrame': '8 Weeks', 'description': "Participant's self care behaviors will be measured using the Health-Promoting Lifestyle Profile-II. This is a 52-item questionnaire that assesses use of behaviors likely to promote a healthy lifestyle and indicate greater selfcare. Responses are categorized into an overall health-promoting lifestyle score as well as subscales assessing health responsibility, physical activity, nutrition, spiritual growth, interpersonal relations, and stress management."}, {'measure': 'Quality of Life -Secondary Efficacy', 'timeFrame': '8 Weeks', 'description': "Participants' quality of life will be assessed using the EORT QLQ-C30, a 30-item measure that assesses quality of life in various domains of functioning and symptoms."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Family Caregiver', 'Well-being'], 'conditions': ['Stress', 'Quality of Life', 'Sleep Disturbance']}, 'referencesModule': {'references': [{'pmid': '38416143', 'type': 'DERIVED', 'citation': 'Gudenkauf LM, Li X, Hoogland AI, Oswald LB, Lmanirad I, Permuth JB, Small BJ, Jim HSL, Rodriguez Y, Bryant CA, Zambrano KN, Walters KO, Reblin M, Gonzalez BD. Feasibility and acceptability of C-PRIME: A health promotion intervention for family caregivers of patients with colorectal cancer. Support Care Cancer. 2024 Feb 28;32(3):198. doi: 10.1007/s00520-024-08395-5.'}], 'seeAlsoLinks': [{'url': 'https://moffitt.org/clinicaltrialssearch?DiseaseSite=&q=21751', 'label': 'Moffitt Cancer Center Clinical Trial Search'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test an intervention to improve health promoting behaviors in family caregivers of patients receiving cancer therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible family caregivers will be:\n* An unpaid family member or friend who provides assistance and support with healthcare of a non-institutionalized patient receiving some form of treatment for stage III or IV colorectal cancer at Moffitt Cancer Center\n* Age 18+ years\n* English or Spanish speaking\n* Able to complete questionnaires and engage in short discussions with coaches\n* Able to identify a primary care medical provider\n* Willing/able to use a mobile device provided by the study team or their own their device.\n\nExclusion Criteria:\n\n* Participants who do not meet the study inclusion criteria'}, 'identificationModule': {'nctId': 'NCT05379933', 'acronym': 'C-PRIME', 'briefTitle': 'Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'C-PRIME: Caregiver Protocol for Remotely Improving, Monitoring, and Extending Quality of Life', 'orgStudyIdInfo': {'id': 'MCC-21751'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C-PRIME', 'description': 'Participants will wear an activity tracker for 8 weeks. During the 8 weeks of the study, participants will complete weekly survey questions about health and well-being and engage in weekly, 15-20 minute telephone/videoconference coaching sessions with a health coach.', 'interventionNames': ['Other: Remote health coaching to improve self-care behaviors']}], 'interventions': [{'name': 'Remote health coaching to improve self-care behaviors', 'type': 'OTHER', 'description': 'Participants will be asked to wear an activity tracker, complete brief surveys, and participate in weekly health coaching sessions remotely for 8 weeks', 'armGroupLabels': ['C-PRIME']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Moffitt Cancer Center', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Brian Gonzalez, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Moffitt Cancer Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}