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

NCT ID: NCT05601206

Last Updated: 2026-01-07

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-14
• Study Completion Date: 2028-06-01

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.

Conditions

Cancer; Depression; Fatigue; Pain; Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Stepped collaborative care intervention

Intervention Type: BEHAVIORAL

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

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.

Group Type: ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type: BEHAVIORAL

Usual care from health providers

Interventions

Stepped collaborative care intervention

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

Intervention Type: BEHAVIORAL

Enhanced Usual Care

Usual care from health providers

Intervention Type: BEHAVIORAL

Other Intervention Names

Treatment; Control

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Steel

Director and Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer L Steel

Role: PRINCIPAL_INVESTIGATOR

UPMC Department of Surgery

Locations

University of Pittsburgh Medical Center Montefiore Liver Cancer Center

Pittsburgh, Pennsylvania, United States

University of Pittsburgh's Medical Center Montefiore Hospital

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY22050018

Identifier Type: -

Identifier Source: org_study_id