Clinical trial NCT05601206: Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE
Official title: Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Cancer
Depression
Fatigue
Pain
Sleep
Keywords: Cancer Depression Fatigue Pain
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sleep Quality
timeFrame: Change from baseline at 6 months
measure: Pain Level
timeFrame: Change from baseline at 6 months
measure: Functioning
timeFrame: Change from baseline at 6 months
measure: Depression
timeFrame: Change from baseline at 6 months
measure: Stress
timeFrame: Change from baseline at 6 months
measure: Fatigue
timeFrame: Change from baseline at 6 months
measure: Caregiver Quality of Life
timeFrame: Change from baseline at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Montefiore Liver Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh's Medical Center Montefiore Hospital
state: Pennsylvania
Study officials:
affiliation: UPMC Department of Surgery
name: Jennifer L Steel
role: PRINCIPAL_INVESTIGATOR
References: