Collaborative Care Intervention for Cancer Patients and Their Family Caregivers -LITE - Clinical Trial for Cancer | NCT05601206

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Primary Purpose

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stepped collaborative care intervention

Enhanced Usual Care

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Cancer Depression Fatigue Pain

Eligibility Criteria

21 Years - 100 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

University of Pittsburgh Medical Center Montefiore Liver Cancer CenterRecruiting
University of Pittsburgh's Medical Center Montefiore HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stepped collaborative care intervention

Enhanced Usual Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

Sleep Quality

Pittsburgh Sleep Quality Index (PSQI)

Pain Level

Brief Pain Inventory (BPI)

Functioning

Functional Assessment for Cancer Therapy Hepatobiliary (FACT - Hep)

Depression

Center for Epidemiological Studies -Depression (CESD)

Stress

Perceived Stress Scale (PSS)

Fatigue

Functional Assessment for Cancer Therapy Fatigue (FACT - Fatigue)

Caregiver Quality of Life

Caregiver Quality of Life Questionnaire (CQOL)

Secondary Outcome Measures

Full Information

NCT ID

NCT05601206

First Posted

August 29, 2022

Last Updated

November 21, 2022

Sponsor

University of Pittsburgh

1. Study Identification

Unique Protocol Identification Number

NCT05601206

Brief Title

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

Acronym

CARES-Lite

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2022

Overall Recruitment Status

Recruiting

Study Start Date

November 14, 2022 (Actual)

Primary Completion Date

December 15, 2024 (Anticipated)

Study Completion Date

December 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Pittsburgh

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cancer, Depression, Fatigue, Pain, Sleep

Keywords

Cancer Depression Fatigue Pain

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized controlled trial

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Stepped collaborative care intervention

Arm Type

Experimental

Arm 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.

Arm Title

Enhanced Usual Care

Arm Type

Active Comparator

Arm 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.

Intervention Type

Behavioral

Intervention Name(s)

Stepped collaborative care intervention

Other Intervention Name(s)

Treatment

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

Enhanced Usual Care

Other Intervention Name(s)

Control

Intervention Description

Usual care from health providers

Primary Outcome Measure Information:

Title

Sleep Quality

Description

Pittsburgh Sleep Quality Index (PSQI)

Time Frame