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

Depression Clinical Trial

— CARES-Lite  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05601206
• Other study ID #: STUDY22050018
• Status: Suspended
• Phase: N/A
• Start date: November 14, 2023
• Est. completion date: June 1, 2027

Study information

• Verified date: March 2024
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 40
• Est. completion date: June 1, 2027
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Depression
• Fatigue
• Pain
• Sleep

Intervention

Behavioral:
• Stepped collaborative care intervention
Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional
• Enhanced Usual Care
Usual care from health providers

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center Montefiore Liver Cancer Center	Pittsburgh	Pennsylvania
United States	University of Pittsburgh's Medical Center Montefiore Hospital	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

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