Web-based Collaborative Care Intervention Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Collaborative Care Intervention for Cancer Patients and Their Family Caregivers

Conditions
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Cancer, Depression, Fatigue, Pain

Intervention / Treatment
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* Behavioral: Stepped collaborative care intervention
* Behavioral: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stepped collaborative care intervention<br>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. | Behavioral: Stepped collaborative care intervention<br>* Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional<br>* Other names: treatment;|
| Active Comparator: Enhanced Usual Care<br>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. | Behavioral: Enhanced Usual Care<br>* usual care from health providers<br>* Other names: control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life (QoL) | Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire | change from baseline at 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum Interleukin (IL)-6,(mg/L) | Blood sample collection and process | change from baseline at 6 months and 12 months | 
| serum Cancer Antigen 19-9 (u/ml) | Blood sample collection and process | change from baseline at 6 months and 12 months | 
| serum carcinoembryonic antigen (u/ml) | Blood sample collection and process | change from baseline at 6 months and 12 months | 
| serum Alpha feta protein (u/ml) | Blood sample collection and process | change from baseline at 6 months and 12 months | 
| Caregivers' stress | Caregiver Quality of Life Scale- Cancer, Perceived Stress Scale | change from baseline at 6 and 12 months | 
| Caregivers' depression | Center for Epidemiological Studies- Depression | change from baseline at 6 and 12 months | 
| dyadic adjustment | Dyadic Adjustment Scale | change from baseline at 6 and 12 months | 
| Caregiver's blood pressure | Blood pressure readings | 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 | change from baseline at 6 and 12 months | 
| Caregiver's serum Interleukin-6 | Blood sample collection and process | 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 | change from baseline at 6 and 12 months | 
| Depression | Center for Epidemiological Studies- Depression | change from baseline at 6 and 12 months | 
| Fatigue | Functional Assessment of Cancer Therapy -fatigue | change from baseline at 6 and 12 months | 
| Pain level | Brief Pain Inventory | change from baseline at 6 and 12 months | 
| serum Interleukin IL-1beta,(mg/L) | cytokine | change from baseline at 6 and 12 months | 
| serum Tumor necrosis factor-alpha ((mg/L) | cytokine | change from baseline at 6 and 12 months | 
| serum Inteferon-gamma ((mg/L) | cytokine | change from baseline at 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Collaborative care intervention, Cancer, Depression, Palliative care, Quality of life, Fatigue, Pain