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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
459
Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional
usual care from health providers
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
Quality of life (QoL)
Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
Time frame: change from baseline at 6 and 12 months
serum Interleukin (IL)-6,(mg/L)
Blood sample collection and process
Time frame: change from baseline at 6 months and 12 months
serum Cancer Antigen 19-9 (u/ml)
Blood sample collection and process
Time frame: change from baseline at 6 months and 12 months
serum carcinoembryonic antigen (u/ml)
Blood sample collection and process
Time frame: change from baseline at 6 months and 12 months
serum Alpha feta protein (u/ml)
Blood sample collection and process
Time frame: change from baseline at 6 months and 12 months
Caregivers' stress
Caregiver Quality of Life Scale- Cancer, Perceived Stress Scale
Time frame: change from baseline at 6 and 12 months
Caregivers' depression
Center for Epidemiological Studies- Depression
Time frame: change from baseline at 6 and 12 months
dyadic adjustment
Dyadic Adjustment Scale
Time frame: change from baseline at 6 and 12 months
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UPMC Presbyterian
Pittsburgh, Pennsylvania, United States
UPMC St. Margaret
Pittsburgh, Pennsylvania, United States
UPMC Horizen
Pittsburgh, Pennsylvania, United States
Caregiver's blood pressure
Blood pressure readings
Time frame: change from baseline at 6 and 12 months
Caregiver's Body Mass Index
Caregiver's height and weight calculations in inches and pounds using BMI calculator
Time frame: change from baseline at 6 and 12 months
Caregiver's serum Interleukin-6
Blood sample collection and process
Time frame: change from baseline at 6 and 12 months
Caregiver's metabolic syndrome
The caregiver meets or does not meet the American Heart Association criteria for metabolic syndrome
Time frame: change from baseline at 6 and 12 months
Depression
Center for Epidemiological Studies- Depression
Time frame: change from baseline at 6 and 12 months
Fatigue
Functional Assessment of Cancer Therapy -fatigue
Time frame: change from baseline at 6 and 12 months
Pain level
Brief Pain Inventory
Time frame: change from baseline at 6 and 12 months
serum Interleukin IL-1beta,(mg/L)
cytokine
Time frame: change from baseline at 6 and 12 months
serum Tumor necrosis factor-alpha ((mg/L)
cytokine
Time frame: change from baseline at 6 and 12 months
serum Inteferon-gamma ((mg/L)
cytokine
Time frame: change from baseline at 6 and 12 months