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

NCT05601206 | Not Yet Recruiting DMC

• 1 other identifier: STUDY22050018
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Cancer; Depression; Fatigue; Pain; Sleep

Keywords

Cancer Depression Fatigue Pain

Outcome Measures

Primary Outcomes (7)

• Sleep Quality

  Pittsburgh Sleep Quality Index (PSQI)

  Change from baseline at 6 months

• Pain Level

  Brief Pain Inventory (BPI)

  Change from baseline at 6 months

• Functioning

  Functional Assessment for Cancer Therapy Hepatobiliary (FACT - Hep)

  Change from baseline at 6 months

• Depression

  Center for Epidemiological Studies -Depression (CESD)

  Change from baseline at 6 months

• Stress

  Perceived Stress Scale (PSS)

  Change from baseline at 6 months

• Fatigue

  Functional Assessment for Cancer Therapy Fatigue (FACT - Fatigue)

  Change from baseline at 6 months

• Caregiver Quality of Life

  Caregiver Quality of Life Questionnaire (CQOL)

  Change from baseline at 6 months

Study Arms (2)

Stepped collaborative care intervention

EXPERIMENTAL

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

Enhanced Usual Care

ACTIVE COMPARATOR

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

Interventions

Enhanced Usual Care BEHAVIORAL

Usual care from health providers

Also known as: Control

Enhanced Usual Care

Stepped collaborative care intervention BEHAVIORAL

Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional

Also known as: Treatment

Stepped collaborative care intervention

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (2)

University of Pittsburgh Medical Center Montefiore Liver Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

Location

University of Pittsburgh's Medical Center Montefiore Hospital

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Neoplasms; Depression; Fatigue; Pain

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations

Study Officials

• Jennifer L Steel

  UPMC Department of Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer L Steel, PhD

CONTACT

14126922041; steeljl@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director and Associate Professor

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: November 1, 2022
• Study Start (Estimated): January 14, 2028
• Primary Completion (Estimated): December 15, 2030
• Study Completion (Estimated): June 1, 2032
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available at the end of the study for up to one year.
• Access Criteria: Appropriate investigator credentials (MD, PhD) and request, and for up to one year after study completion

Locations

US (2)