Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT05601206
Status:
SUSPENDED
Last Update Posted:
2025-04-03
First Post:
2022-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'whyStopped': 'Care coordinators graduated', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2025-11-14', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-31', 'studyFirstSubmitDate': '2022-08-29', 'studyFirstSubmitQcDate': '2022-10-26', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sleep Quality', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Pittsburgh Sleep Quality Index (PSQI)'}, {'measure': 'Pain Level', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Brief Pain Inventory (BPI)'}, {'measure': 'Functioning', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Functional Assessment for Cancer Therapy Hepatobiliary (FACT - Hep)'}, {'measure': 'Depression', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Center for Epidemiological Studies -Depression (CESD)'}, {'measure': 'Stress', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Perceived Stress Scale (PSS)'}, {'measure': 'Fatigue', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Functional Assessment for Cancer Therapy Fatigue (FACT - Fatigue)'}, {'measure': 'Caregiver Quality of Life', 'timeFrame': 'Change from baseline at 6 months', 'description': 'Caregiver Quality of Life Questionnaire (CQOL)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cancer Depression Fatigue Pain'], 'conditions': ['Cancer', 'Depression', 'Fatigue', 'Pain', 'Sleep']}, 'descriptionModule': {'briefSummary': 'To test the efficacy of a web-based stepped collaborative care intervention to reduce symptoms of depression, pain, and fatigue and improve health-related quality of life (HRQL) in advanced cancer patients and to reduce stress and depression, and fewer CVD risk factors in caregivers.', 'detailedDescription': "The intervention is designed to maintain quality of life for those in greatest need and least access to resources. This innovative and scalable web-based collaborative care intervention is expected not only to improve patients' quality of life, at the end of life, but also reduce caregiver stress and depression, and potentially health morbidity and mortality of patients and spousal and intimate partner caregivers from socioeconomically disadvantaged backgrounds. Study findings are expected to lead to research examining the dissemination and implementation of the intervention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients:\n\nBiopsy and/or radiograph proven diagnosis of hepatocellular carcinoma, cholangiocarcinoma, gallbladder carcinoma or breast, ovarian, or colorectal cancer with liver metastases with a life expectancy of at least one year; age \\>21 years; no evidence of thought disorder, delusions, or active suicidal ideation is observed or reported.\n\n* Caregivers:\n\nA spouse or cohabitating intimate partner of an advanced cancer patient being evaluated the UPMC's Liver Cancer Center and age \\>21 years\n\nExclusion Criteria:\n\n* Patients:\n\nAge \\< 21 years, Lack of fluency in English, Evidence of thought disorder, delusions, hallucinations, or suicidal ideation.\n\n* Caregivers:\n\nAge \\< 21 years, Lack of fluency in English, Evidence of thought disorder, delusions, hallucinations, or suicidal ideation."}, 'identificationModule': {'nctId': 'NCT05601206', 'acronym': 'CARES-Lite', 'briefTitle': 'Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE', 'orgStudyIdInfo': {'id': 'STUDY22050018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stepped collaborative care intervention', 'description': "The 'Stepped Collaborative Care Intervention' includes at least biweekly contact from a care coordinator by phone and face to face visits occurring approximately every 2 months, and 24 hour 7 day a week access to a website that was specifically designed during the pilot study for advanced cancer patients from socioeconomically disadvantaged backgrounds.", 'interventionNames': ['Behavioral: Stepped collaborative care intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Enhanced Usual Care', 'description': "Patients randomized to the 'Enhanced Usual Care' arm receive their usual care from their medical team. However, if the patient scores in the clinical range on one or more of the three symptoms s/he will receive education about the symptom and be referred to the appropriate health care provider for further treatment in their community. The care coordinator will follow up with the patient after 3 weeks to assess barriers to treatment and assist further with accessing treatment if needed.", 'interventionNames': ['Behavioral: Enhanced Usual Care']}], 'interventions': [{'name': 'Stepped collaborative care intervention', 'type': 'BEHAVIORAL', 'otherNames': ['Treatment'], 'description': 'Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional', 'armGroupLabels': ['Stepped collaborative care intervention']}, {'name': 'Enhanced Usual Care', 'type': 'BEHAVIORAL', 'otherNames': ['Control'], 'description': 'Usual care from health providers', 'armGroupLabels': ['Enhanced Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center Montefiore Liver Cancer Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "University of Pittsburgh's Medical Center Montefiore Hospital", 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Jennifer L Steel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UPMC Department of Surgery'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Data will be available at the end of the study for up to one year.', 'ipdSharing': 'YES', 'description': 'De-Identified Data may be shared with investigators who request data from the Primary Investigator', 'accessCriteria': 'Appropriate investigator credentials (MD, PhD) and request, and for up to one year after study completion'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director and Associate Professor', 'investigatorFullName': 'Jennifer Steel', 'investigatorAffiliation': 'University of Pittsburgh'}}}}