RecruitingNot Applicable

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

United States1,750 participantsStarted 2025-08-08

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Functional Assessment of Cancer Therapy-General

Timeframe: Enrollment to the end of study for participant (12 months). The primary time point is 6 months

Functional Assessment of Cancer Therapy-General

Timeframe: Enrollment to the end of study for participant (12 months). The 12 months outcome will be a measure of maintenance of benefits.

Trial details

NCT IDNCT07183527

SponsorUniversity of Pittsburgh

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-01-10

Contact for this trial

Jennifer L Steel, PhD

14126922041 Steejl@upmc.edu

View on ClinicalTrials.gov More CARES trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Functional Assessment of Cancer Therapy-General

Timeframe: Enrollment to the end of study for participant (12 months). The primary time point is 6 months

Functional Assessment of Cancer Therapy-General

Timeframe: Enrollment to the end of study for participant (12 months). The 12 months outcome will be a measure of maintenance of benefits.