Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT07183527

Conditions

CARES

Standard of Care

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CARES

Standard of Care (SOC)

Study Details

Brief summary:

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

Conditions

CARES

Standard of Care

Study ID

NCT07183527

Start date

Aug 8, 2025

Status verified date

Aug, 2026

Completion date

Jan 31, 2030

Anticipated

Primary completion date

Jan 10, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1750 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

Interventions

CARES

Integrated screening and stepped collaborative care

Standard of Care (SOC)

Screening and referral of patient to provider in the community or 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 ]
  • Functional Assessment of Cancer Therapy-General [ Time Frame: Enrollment to the end of study for participant (12 months). The 12 months outcome will be a measure of maintenance of benefits. ]

Central Contacts and Locations

Central contacts

Jennifer L Steel, PhD

14126922041Steejl@upmc.edu

Jennifer L Steel

4126922041steejl@upmc.edu

Locations

University of Pittsburgh Medical Center (UPMC) Cancer Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Jennifer L Steel, PhD

412-692-2041steejl@upmc.edu

More Information

Sponsor

University of Pittsburgh

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • implementation
  • stepped collaborative care
  • integrated screening and treatment
  • cluster randomized controlled trial
  • cancer
  • screening

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-08-10.