Web-based Collaborative Care Intervention Study
- Conditions
- DepressionPainCancerFatigue
- Interventions
- Behavioral: Enhanced Usual CareBehavioral: Stepped collaborative care intervention
- Registration Number
- NCT02939755
- Lead Sponsor
- University of Pittsburgh
- Brief Summary
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.
- Detailed Description
The investigators will enroll patients at two UPMC sites: Montefiore Hospital, an academic medical center, and Passavant Hospital, a community based hospital. Based on our sample size estimate the investigators will have at least 364 patients and caregivers with complete data at 12 months follow up.
The patient and caregiver will be randomly assigned to one of two arms (intervention versus enhanced usual care) stratified by gender and vessel invasion. Because these factors are the two most robust prognostic factors in this patient population. At 6 and 12 months after enrollment, follow-up questionnaires and blood draws will be performed for patients and caregivers.
The stepped WBCC 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. 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.
Intervention fidelity (e.g., consistency across care coordinators) will be reduced by requiring the care coordinators to follow a 300 page manual and providing standardized training by the PI who is a clinical psychologist. Dr. Steel (PI) has received training and certification from the American Psycho-Oncology Society in the design and analysis of psycho-oncology clinical trials and intervention fidelity. The study investigators will not prescribe any medications but rather make recommendations to the patient's oncologist, PCP, psychiatrist, or pain management specialist who will be free to accept or reject the recommendations by the study team. Medication type, dosage, and adherence to medication (e.g., self-report and pharmacy refills) will be recorded for patients in the WBCC intervention and enhanced usual care arms.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 459
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
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced Usual Care Enhanced Usual Care 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. Stepped collaborative care intervention Stepped collaborative care intervention 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.
- Primary Outcome Measures
Name Time Method Quality of life (QoL) change from baseline at 6 and 12 months Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
- Secondary Outcome Measures
Name Time Method serum Alpha feta protein (u/ml) change from baseline at 6 months and 12 months Blood sample collection and process
Caregivers' stress change from baseline at 6 and 12 months Caregiver Quality of Life Scale- Cancer, Perceived Stress Scale
Caregiver's serum Interleukin-6 change from baseline at 6 and 12 months Blood sample collection and process
serum Interleukin (IL)-6,(mg/L) change from baseline at 6 months and 12 months Blood sample collection and process
Caregiver's blood pressure change from baseline at 6 and 12 months Blood pressure readings
serum Cancer Antigen 19-9 (u/ml) change from baseline at 6 months and 12 months Blood sample collection and process
dyadic adjustment change from baseline at 6 and 12 months Dyadic Adjustment Scale
Caregiver's Body Mass Index change from baseline at 6 and 12 months Caregiver's height and weight calculations in inches and pounds using BMI calculator
serum Interleukin IL-1beta,(mg/L) change from baseline at 6 and 12 months cytokine
serum Tumor necrosis factor-alpha ((mg/L) change from baseline at 6 and 12 months cytokine
serum Inteferon-gamma ((mg/L) change from baseline at 6 and 12 months cytokine
serum carcinoembryonic antigen (u/ml) change from baseline at 6 months and 12 months Blood sample collection and process
Caregivers' depression change from baseline at 6 and 12 months Center for Epidemiological Studies- Depression
Depression change from baseline at 6 and 12 months Center for Epidemiological Studies- Depression
Caregiver's metabolic syndrome change from baseline at 6 and 12 months The caregiver meets or does not meet the American Heart Association criteria for metabolic syndrome
Fatigue change from baseline at 6 and 12 months Functional Assessment of Cancer Therapy -fatigue
Pain level change from baseline at 6 and 12 months Brief Pain Inventory
Trial Locations
- Locations (7)
The University of Pittsburgh's Medical Center Passavant Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC St. Margaret
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC East
🇺🇸Monroeville, Pennsylvania, United States
University of Pittsburgh Medical Center Mercy
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Presbyterian
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh's Medical Center Montefiore Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
UPMC Horizen
🇺🇸Pittsburgh, Pennsylvania, United States