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NCT Number: NCT05601206

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

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.

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Key information

Conditions

Cancer Behavior Behavioral Symptoms Depression Fatigue Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center Montefiore Liver Cancer Center, Pittsburgh, Pennsylvania, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stepped collaborative care intervention

Behavioral

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

Other names: Treatment

Enhanced Usual Care

Behavioral

Usual care from health providers

Other names: Control

Primary outcomes

  1. Sleep Quality

    Time frame: Change from baseline at 6 months

    Pittsburgh Sleep Quality Index (PSQI)

  2. Pain Level

    Time frame: Change from baseline at 6 months

    Brief Pain Inventory (BPI)

  3. Functioning

    Time frame: Change from baseline at 6 months

    Functional Assessment for Cancer Therapy Hepatobiliary (FACT - Hep)

  4. Depression

    Time frame: Change from baseline at 6 months

    Center for Epidemiological Studies -Depression (CESD)

  5. Stress

    Time frame: Change from baseline at 6 months

    Perceived Stress Scale (PSS)

  6. Fatigue

    Time frame: Change from baseline at 6 months

    Functional Assessment for Cancer Therapy Fatigue (FACT - Fatigue)

  7. Caregiver Quality of Life

    Time frame: Change from baseline at 6 months

    Caregiver Quality of Life Questionnaire (CQOL)

Study contacts

Contact information is provided by the study sponsor or research team.

Jennifer L Steel, PhD

CONTACT

[email protected]

14126922041

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Acronym: CARES-Lite

Important dates

Study start
2028
Primary completion
2030
Study completion
2032
First posted
Nov 1, 2022
Registry last updated
Apr 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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