Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE

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 intervention is designed to maintain quality of life for those in greatest need and least access to resources. This innovative and scalable web-based collaborative care intervention is expected not only to improve patients' quality of life, at the end of life, but also reduce caregiver stress and depression, and potentially health morbidity and mortality of patients and spousal and intimate partner caregivers from socioeconomically disadvantaged backgrounds. Study findings are expected to lead to research examining the dissemination and implementation of the intervention.

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

Conditions
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Cancer, Depression, Fatigue, Pain, Sleep

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 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: Age < 21 years, Lack of fluency in English, 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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Accepts Healthy Volunteers

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
Interventional Model Description: Randomized controlled trial
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 |
| --- | --- | --- |
| Sleep Quality | Pittsburgh Sleep Quality Index (PSQI) | Change from baseline at 6 months | 
| Pain Level | Brief Pain Inventory (BPI) | Change from baseline at 6 months | 
| Functioning | Functional Assessment for Cancer Therapy Hepatobiliary (FACT - Hep) | Change from baseline at 6 months | 
| Depression | Center for Epidemiological Studies -Depression (CESD) | Change from baseline at 6 months | 
| Stress | Perceived Stress Scale (PSS) | Change from baseline at 6 months | 
| Fatigue | Functional Assessment for Cancer Therapy Fatigue (FACT - Fatigue) | Change from baseline at 6 months | 
| Caregiver Quality of Life | Caregiver Quality of Life Questionnaire (CQOL) | Change from baseline at 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cancer Depression Fatigue Pain