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

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
University of Pittsburgh
Study ID
NCT07183527
Status
Recruiting
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Conditions

  • CARES
  • Standard of Care

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Aug 8, 2025
Status verified
Sep 2025
Primary completion
Jan 10, 2030
Completion
Jan 31, 2030

Study Design

Enrollment
1,750 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: CARES
    Integrated Screening and Stepped Collaborative Care Intervention
  • Active Comparator: Standard of Care (SOC)
    Integrated screening and referred to treatment in the community and/or at the cancer center

Primary Outcome Measure

Functional Assessment of Cancer Therapy-General [ Time Frame: Enrollment to the end of study for participant (12 months). The primary time point is 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Medical Center (UPMC) Cancer CenterPittsburghPennsylvania15213
Jennifer L Steel, PhD
[email protected]
4126922041

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University of Pittsburgh Medical Center (UPMC) Cancer Center· Pittsburgh, PA