Testing CARES, an integrated screening and stepped-care program, versus standard care in cancer clinics
Hybrid Type I Effectiveness-Implementation Cluster Randomized Trial of CARES
This trial will test whether CARES helps adults with cancer reduce pain, fatigue, and depression and start treatment more often than standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07183527 on ClinicalTrials.gov |
What this trial studies
CARES is an integrated screening and stepped collaborative care intervention designed to identify and treat depression, pain, and fatigue in people with cancer. In a pragmatic, cluster-randomized, hybrid type I effectiveness-implementation design, cancer clinics are randomized to offer CARES or continue standard care while investigators measure patient outcomes, implementation barriers and facilitators, and costs. Eligible participants are adults (≥18) with a cancer diagnosis who can read and write English, with exclusions for active psychosis or suicidal ideation with a plan. The trial includes a RE-AIM–guided implementation process evaluation and a full cost-effectiveness analysis to prepare for broader dissemination.
Who should consider this trial
Good fit: Adults aged 18 or older with a cancer diagnosis who can read and write English and who do not have active psychosis or suicidal ideation are the ideal candidates for this trial.
Not a fit: Patients with evidence of thought disorder, delusions, hallucinations, active suicidal ideation with a plan, children, or those who cannot read/write English may not be eligible or likely to benefit from this intervention.
Why it matters
Potential benefit: If successful, CARES could increase treatment initiation, improve quality of life and symptom burden, reduce emergency care and hospital use, and lower overall healthcare costs.
How similar studies have performed: Prior research of CARES found 75% versus 4% treatment initiation compared with standard care, plus improvements in quality of life, symptoms, and substantial healthcare cost savings, supporting real-world testing.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh Medical Center (UPMC) Cancer Center — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Jennifer L Steel, PhD — University of Pittsburgh
- Study coordinator: Jennifer L Steel, PhD
- Email: Steejl@upmc.edu
- Phone: 14126922041
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.