Cancer, Depression, Fatigue, Pain, Sleep
Conditions
Keywords
Cancer Depression Fatigue Pain
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.
Interventions
BEHAVIORALStepped collaborative care intervention
Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional
BEHAVIORALEnhanced Usual Care
Usual care from health providers
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
21 Years to 100 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep Quality | Change from baseline at 6 months | Pittsburgh Sleep Quality Index (PSQI) |
| 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) |
| Depression | Change from baseline at 6 months | Center for Epidemiological Studies -Depression (CESD) |
| Stress | Change from baseline at 6 months | Perceived Stress Scale (PSS) |
| Fatigue | Change from baseline at 6 months | Functional Assessment for Cancer Therapy Fatigue (FACT - Fatigue) |
| Caregiver Quality of Life | Change from baseline at 6 months | Caregiver Quality of Life Questionnaire (CQOL) |
Countries
United States
Contacts
CONTACTJennifer L Steel, PhD
PRINCIPAL_INVESTIGATORJennifer L Steel
UPMC Department of Surgery
Outcome results
None listed