NCT07183527

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

Hybrid Type I Effectiveness-Implementation Cluster Randomized Trial of CARES

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,750 (estimated)
• Sponsor: University of Pittsburgh · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CARES
• Standard of Care

Interventions

Type	Name	Description
BEHAVIORAL	CARES	Integrated screening and stepped collaborative care
BEHAVIORAL	Standard of Care (SOC)	Screening and referral of patient to provider in the community or cancer center

Timeline

• Start date: 2025-08-08
• Primary completion: 2030-01-10
• Completion: 2030-01-31
• First posted: 2025-09-19
• Last updated: 2025-09-19

Locations

1 site across 1 country: United States