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

University of Pittsburgh

Status: Suspended

Conditions: Depression; Cancer; Fatigue; Pain; Sleep

Treatments: Behavioral: Enhanced Usual Care; Behavioral: Stepped collaborative care intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05601206

STUDY22050018

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 21 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Stepped collaborative care intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Stepped collaborative care intervention

Enhanced Usual Care

Active Comparator group

Description:

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.

Treatment:

Behavioral: Enhanced Usual Care