Hybrid Type I Effectiveness-implementation Cluster Randomized Controlled Trial of CARES
NCT ID: NCT07183527
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1750 participants
INTERVENTIONAL
2025-08-08
2030-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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CARES
Integrated Screening and Stepped Collaborative Care Intervention
CARES
Integrated screening and stepped collaborative care
Standard of Care (SOC)
Integrated screening and referred to treatment in the community and/or at the cancer center
Standard of Care (SOC)
Screening and referral of patient to provider in the community or cancer center
Interventions
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CARES
Integrated screening and stepped collaborative care
Standard of Care (SOC)
Screening and referral of patient to provider in the community or cancer center
Eligibility Criteria
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Inclusion Criteria
* Age 18 years or older
* Read and write in English
Exclusion Criteria
* Evidence of delusions
* Evidence of hallucinations
* Evidence of suicidal ideation with a plan
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Pittsburgh
OTHER
Responsible Party
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Jennifer Steel
Professor
Principal Investigators
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Jennifer L Steel, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh
Locations
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University of Pittsburgh Medical Center (UPMC) Cancer Center
Pittsburgh, Pennsylvania, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STUDY24070065
Identifier Type: -
Identifier Source: org_study_id
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