Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE
- Conditions
- DepressionPainCancerFatigueSleep
- Interventions
- Behavioral: Stepped collaborative care interventionBehavioral: Enhanced Usual Care
- Registration Number
- NCT05601206
- 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 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.
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 40
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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. 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.
- Primary Outcome Measures
Name Time Method Caregiver Quality of Life Change from baseline at 6 months Caregiver Quality of Life Questionnaire (CQOL)
Sleep Quality Change from baseline at 6 months Pittsburgh Sleep Quality Index (PSQI)
Depression Change from baseline at 6 months Center for Epidemiological Studies -Depression (CESD)
Fatigue Change from baseline at 6 months Functional Assessment for Cancer Therapy Fatigue (FACT - Fatigue)
Pain Level Change from baseline at 6 months Brief Pain Inventory (BPI)
Functioning Change from baseline at 6 months Functional Assessment for Cancer Therapy Hepatobiliary (FACT - Hep)
Stress Change from baseline at 6 months Perceived Stress Scale (PSS)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
University of Pittsburgh Medical Center Montefiore Liver Cancer Center
🇺🇸Pittsburgh, Pennsylvania, United States
University of Pittsburgh's Medical Center Montefiore Hospital
🇺🇸Pittsburgh, Pennsylvania, United States