Web-based Collaborative Care Intervention Study
Condition: Cancer; Depression; Fatigue; Pain
MeSH terms: Fatigue; Depression
Study type: Interventional

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.
    

Intervention name(s): Stepped collaborative care intervention; Enhanced Usual Care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional; usual care from health providers
Other intervention name(s): treatment; control
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Collaborative care intervention; Cancer; Depression; Palliative care; Quality of life; Fatigue; Pain