Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE (CARES-Lite)

April 4, 2026 updated by: Jennifer Steel, University of Pittsburgh
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh's Medical Center Montefiore Hospital
        • Contact:
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center Montefiore Liver Cancer Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Behavioral: Stepped collaborative care intervention
Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional
Other Names:
  • Treatment
Active Comparator: 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.
Behavioral: Enhanced Usual Care
Usual care from health providers
Other Names:
  • Control

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Jennifer L Steel, UPMC Department of Surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 14, 2028

Primary Completion (Estimated)

December 15, 2030

Study Completion (Estimated)

June 1, 2032

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

October 26, 2022

First Posted (Actual)

November 1, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2026

Last Update Submitted That Met QC Criteria

April 4, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY22050018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-Identified Data may be shared with investigators who request data from the Primary Investigator

IPD Sharing Time Frame

Data will be available at the end of the study for up to one year.

IPD Sharing Access Criteria

Appropriate investigator credentials (MD, PhD) and request, and for up to one year after study completion

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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