Depression Clinical Trial
— WBCCIOfficial title:
Collaborative Care Intervention for Cancer Patients and Their Family Caregivers
Verified date | September 2023 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 459 |
Est. completion date | July 1, 2023 |
Est. primary completion date | July 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 100 Years |
Eligibility | Inclusion Criteria: Patients: - biopsy 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. Caregivers: - a spouse or cohabitating intimate partner of an advanced cancer patient being evaluated at the UPMC's Liver Cancer Center and - age >21 years Exclusion Criteria: Patients: - age < 21 years, - lack of fluency in English, - evidence of thought disorder, delusions, hallucinations, or suicidal ideation. Caregivers: - lack of fluency in English; and - evidence of thought disorder, delusions, hallucinations, or suicidal ideation. |
Country | Name | City | State |
---|---|---|---|
United States | UPMC East | Monroeville | Pennsylvania |
United States | The University of Pittsburgh's Medical Center Passavant Hospital | Pittsburgh | Pennsylvania |
United States | University of Pittsburgh Medical Center Mercy | Pittsburgh | Pennsylvania |
United States | University of Pittsburgh's Medical Center Montefiore Hospital | Pittsburgh | Pennsylvania |
United States | UPMC Horizen | Pittsburgh | Pennsylvania |
United States | UPMC Presbyterian | Pittsburgh | Pennsylvania |
United States | UPMC St. Margaret | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Health care utilization | Emergency Room visits, 30- and 90-day readmissions, length of stay in the hospital. | 1 year | |
Other | Health care costs | activity based costs | 12 months | |
Primary | Quality of life (QoL) | Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire | change from baseline at 6 and 12 months | |
Secondary | serum Interleukin (IL)-6,(mg/L) | Blood sample collection and process | change from baseline at 6 months and 12 months | |
Secondary | serum Cancer Antigen 19-9 (u/ml) | Blood sample collection and process | change from baseline at 6 months and 12 months | |
Secondary | serum carcinoembryonic antigen (u/ml) | Blood sample collection and process | change from baseline at 6 months and 12 months | |
Secondary | serum Alpha feta protein (u/ml) | Blood sample collection and process | change from baseline at 6 months and 12 months | |
Secondary | Caregivers' stress | Caregiver Quality of Life Scale- Cancer, Perceived Stress Scale | change from baseline at 6 and 12 months | |
Secondary | Caregivers' depression | Center for Epidemiological Studies- Depression | change from baseline at 6 and 12 months | |
Secondary | dyadic adjustment | Dyadic Adjustment Scale | change from baseline at 6 and 12 months | |
Secondary | Caregiver's blood pressure | Blood pressure readings | change from baseline at 6 and 12 months | |
Secondary | Caregiver's Body Mass Index | Caregiver's height and weight calculations in inches and pounds using BMI calculator | change from baseline at 6 and 12 months | |
Secondary | Caregiver's serum Interleukin-6 | Blood sample collection and process | change from baseline at 6 and 12 months | |
Secondary | Caregiver's metabolic syndrome | The caregiver meets or does not meet the American Heart Association criteria for metabolic syndrome | change from baseline at 6 and 12 months | |
Secondary | Depression | Center for Epidemiological Studies- Depression | change from baseline at 6 and 12 months | |
Secondary | Fatigue | Functional Assessment of Cancer Therapy -fatigue | change from baseline at 6 and 12 months | |
Secondary | Pain level | Brief Pain Inventory | change from baseline at 6 and 12 months | |
Secondary | serum Interleukin IL-1beta,(mg/L) | cytokine | change from baseline at 6 and 12 months | |
Secondary | serum Tumor necrosis factor-alpha ((mg/L) | cytokine | change from baseline at 6 and 12 months | |
Secondary | serum Inteferon-gamma ((mg/L) | cytokine | change from baseline at 6 and 12 months |
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