Hybrid Type I Effectiveness-implementation Cluster Randomized Controlled Trial of CARES

Not Applicable

Recruiting

• Conditions: CARES; Standard of Care

• Registration Number: NCT07183527
• Lead Sponsor: University of Pittsburgh

Brief Summary

The trial will examine the effectiveness and facilitators and barriers of implementation of CARES, an integrated screening and stepped collaborative care intervention

Detailed Description

Over 18 million Americans are living with cancer. Half of them report clinically significant levels of depression, pain, and/or fatigue. According to the NIH consensus statement, these are the three most common and distressing cancer-related symptoms. These symptoms lead to poorer health-related quality of life (HRQoL) and cancer-related treatment adherence, higher unplanned health care utilization and costs, and reduced life expectancy.

Investigators observed in a trial of CARES, an integrated screening and stepped collaborative care intervention, that 75% versus 4% of participants initiated treatment when compared to standard of care. Improvements in HRQoL and reductions in pain, depression, fatigue, emergency room visits, readmissions to the hospital, and length of stay in the hospital were observed. The cost savings to the health care system was $17,085 per patient per year when compared to standard of care.

The overarching objective of the proposed study is to move CARES from research to routine clinical care. Investigators plans to test the effectiveness of CARES in a pragmatic trial or "real world" setting. An implementation-focused process evaluation of participant and clinician engagement with CARES guided by the RE-AIM framework will also be performed. Finally, to prepare to disseminate the intervention, a full cost-effectiveness analysis of CARES will be conducted.

Study Timeline

• Study Start: 2025-08-08
• Study First Submitted: 2025-08-22
• Status Verified: 2025-09
• Study First Submitted QC: 2025-09-16
• Last Update Submitted: 2025-09-16
• Study First Posted: 2025-09-19
• Last Update Posted: 2025-09-19
• Primary Completion: 2030-01-10
• Study Completion: 2030-01-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1750

Inclusion Criteria

• Diagnosis of Cancer
• Age 18 years or older
• Read and write in English

Exclusion Criteria

• Evidence of thought disorder
• Evidence of delusions
• Evidence of hallucinations
• Evidence of suicidal ideation with a plan

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional Assessment of Cancer Therapy-General	Enrollment to the end of study for participant (12 months). The 12 months outcome will be a measure of maintenance of benefits.	Health Related Quality of Life. A total score (0-108) and subscales scores (0-24 or 0-28) with a higher score reflecting a better quality of life

Secondary Outcome Measures

Name	Time	Method
EQ 5D 5L (this is the title of the instrument there is no non abbreviated title)	Enrollment to the end of study for participant (12 months). The primary time point is 12 months.	Health related quality of life. Total score ranges from 0-25 for part 1 and 0 to 100 for part 2. A higher score reflects a better quality of life.
Cost Assessment	Enrollment to the end of study for participant (12 months). The primary time point is 12 months.	Health Care Utilization. There is no total score for this questionnaire as it will be used to estimate costs.
Activity Based Costs	Enrollment to the end of study for participant (12 months). The primary time point is 12 months.	Health care costs. Range could be 0 to 10 million dollars
Patient Health Questionnaire-9	Screening to baseline and baseline to 12 months. The 12 months outcome will be a measure of maintenance of benefits.	Depressive Symptoms. Scores range from 0-27 with a higher score reflecting higher levels of depressive symptoms
Brief Pain Inventory.	Screening to baseline and baseline to 12 months. The 12 month PEG score will reflect maintenance of treatment.	Pain intensity and interference. The Pain, Enjoyment, and General Activity score (0-10) will be used as the secondary outcome. A higher score reflects greater pain interference.
Generalized Anxiety Disorder -7	Screening to baseline and baseline to 12 months. The 12 months time point will assess maintenance of change.	Anxiety. The total score ranges from 0-21. A higher score indicates higher levels of anxiety.
FACIT Fatigue	Enrollment to the end of study for participant (12 months). The 12 months time point will reflect maintenance of change in fatigue.	Fatigue. A total score ranges from 0-52. A higher score indicates less fatigue.
PROMIS Depression	Enrollment to the end of study for participant (12 months). The 12 month time point will be used to assess maintenance of change.	Depressive symptoms. The range is from 0-100 with a higher score reflecting higher levels of depressive symptoms.
PROMIS Anxiety	Enrollment to the end of study for participant (12 months). The 12 months time point is to assess maintenace of change.	Anxiety. Scores range from 0-100 and a higher score reflects worse anxiety.
Fatigue Assessment Scale	Enrollment to the end of study for participant (12 months). The 12 months time point will assess maintenance of change.	Fatigue. The total score ranges from 10 to 50. A higher score reflects more severe fatigue.
Pain Visual Analog Scale	Enrollment to the end of study for participant (12 months). The 12 months time point is to assess maintenance of change.	Pain Severity. Total score ranges from 0-100. A higher score reflects higher levels of pain.
Pittsburgh Sleep Quality Index	Enrollment to the end of study for participant (12 months). The 12 months time point is to assess maintenance of change.	Sleep problems. The total sleep quality (0-21) and subscales including the sleep duration (0-24), sleep disturbance (0-3), sleep latency (0-3), days of dysfunction (0-3), efficiency (0-3), overall sleep quality (0-3), medications to sleep (0-3). A higher score means more sleep problems.
Interpersonal Support Evaluation List	Enrollment to the end of study for participant (12 months). The 12-month time point will assess maintenance of change	Social support. A higher score reflects better social support. The range of scores 0-48 with subscales including appraisal (0-16), belonging (0-16), and tangible (0-16).
COST	Enrollment to the end of study for participant (12 months). The primary time point will be at 12 months.	Financial toxicity. The range of scores is from 0-44 and a higher scores reflects a better financial well being.
Cost Coping	Enrollment to the end of study for participant (12 months). The primary time point will be 12 months.	Cost coping strategies. The total score is the number of cost coping strategies a patient uses to manage their financial costs associated with their medical care. The total number of cost coping strategies is 0-26.
Adherence to outpatient appointment	Enrollment to the end of study for participant (12 months). The primary time point is 12 months.	Adherence to outpatient appointments. Percent of appointments missed out of total appointment in 12 months.
Complications	Baseline to 12 months	Number of complications from procedures or surgeries during 12 months post randomization. The primary time point is 12 months.
Length of Stay in the Hospital	Baseline to 12 months	Number of days patient was in the hospital. The primary end point is 12 months
Emergency Room Visits	12 months	Number of emergency room visits in 12 months post-randomization. The primary end point is 12 months
30-day readmissions	Baseline to 12 months	Unplanned readmission to the hospital after a procedure or surgery within 30 days. Primary end point 12 months
90-day readmission	Baseline to 12 months	Unplanned readmission to the hospital after a procedure or surgery within 90 days. The primary endpoint is 12 months
PROMIS Fatigue	Screening to baseline and baseline to 12 months	Assesses fatigue in cancer patients. Higher score reflects greater fatigue. Score range from a T score 0-100. Secondary endpoint 12 months

Trial Locations

Locations (1)

University of Pittsburgh Medical Center (UPMC) Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States