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

NCT07183527 | Recruiting DMC

• 2 other identifiers: STUDY240700651R01CA296402
• Study Type: interventional
• Target: 1,750
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Functional Assessment of Cancer Therapy-General

  Health Related Quality of Life. A total score (0-108) and subscales scores (0-24 or 0-28) with a higher score reflecting a better quality of life

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

• Functional Assessment of Cancer Therapy-General

  Health Related Quality of Life. A total score (0-108) and subscales scores (0-24 or 0-28) with a higher score reflecting a better quality of life

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

Secondary Outcomes (33)

• Patient Health Questionnaire-9

  Screening to baseline and baseline to 12 months. The primary outcome will be at 6-months.

• Brief Pain Inventory.

  Screening to baseline and baseline to 12 months. The primary outcome will be from baseline to 6-months

• Generalized Anxiety Disorder -7

  Screening to baseline and baseline to 12 months. The primary time point is from baseline to 6 months.

• FACIT Fatigue

  Baseline to 12 months. The primary time point will be 6 months.

• PROMIS Depression

  Baseline to 12 months. The primary time point is 6 months. The questionnaire will be used for treatment response 0-24 weeks (every 4 weeks).

Other Outcomes (32)

• Modified Adverse Childhood Events

  The questionnaire will only be administered at baseline

• Sociodemographic factors

  Administered at baseline only.

• Adherence to experimental treatment

  Baseline to 12 months

Study Arms (2)

CARES

EXPERIMENTAL

Integrated Screening and Stepped Collaborative Care Intervention

Behavioral: CARES

Standard of Care (SOC)

ACTIVE COMPARATOR

Integrated screening and referred to treatment in the community and/or at the cancer center

Behavioral: Standard of Care (SOC)

Interventions

CARES BEHAVIORAL

Integrated screening and stepped collaborative care

CARES

Standard of Care (SOC) BEHAVIORAL

Screening and referral of patient to provider in the community or cancer center

Standard of Care (SOC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Cancer
• Age 18 years or older
• Read and write in English

You may not qualify if:

• Evidence of thought disorder
• Evidence of delusions
• Evidence of hallucinations
• Evidence of suicidal ideation with a plan

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Pittsburgh Medical Center (UPMC) Cancer Center

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Jennifer L Steel, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer L Steel, PhD

CONTACT

14126922041; Steejl@upmc.edu

Jennifer L Steel

CONTACT

4126922041; steejl@upmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Cluster Randomized Controlled Trial

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 19, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): January 10, 2030
• Study Completion (Estimated): January 31, 2030
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: After final outcomes are reported in published format
• Access Criteria: Qualified researchers with aims and hypotheses that are approved by the study team

Locations

US (1)