Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Testing CARES, an integrated screening and stepped-care program, versus standard care in cancer clinics

Official title: Hybrid Type I Effectiveness-Implementation Cluster Randomized Trial of CARES

Run by University of Pittsburgh · NCT07183527 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment1750 (estimated)
SponsorUniversity of Pittsburgh
Academic / other
Locations1 site (Pittsburgh, Pennsylvania)
StatusRecruiting
StartedAugust 8, 2025
Main results expectedJanuary 10, 2030
Study endsJanuary 31, 2030
Registry record updatedAugust 10, 2026
Trial IDNCT07183527 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.