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

University of Pittsburgh2 sites in 1 country40 target enrollmentJanuary 14, 2028

ConditionsCancer Depression Fatigue Pain Sleep

InterventionsStepped collaborative care intervention Enhanced Usual Care

Overview

Phase: N/A
Intervention: Stepped collaborative care intervention
Conditions: Cancer
Sponsor: University of Pittsburgh
Enrollment: 40
Locations: 2
Primary Endpoint: Caregiver Quality of Life
Status: Not Yet Recruiting
Last Updated: 23 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 14, 2028

End Date

June 1, 2032

Last Updated

23 days ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

University of Pittsburgh

Responsible Party

Principal Investigator

Jennifer Steel

Director and Associate Professor

University of Pittsburgh

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.

Arms & Interventions

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.

Intervention: Stepped collaborative care intervention

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.

Intervention: Enhanced Usual Care