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

University of Pittsburgh

Status: Enrolling

Conditions: CARES; Standard of Care

Treatments: Behavioral: CARES; Behavioral: Standard of Care (SOC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07183527

1R01CA296402 (U.S. NIH Grant/Contract)

STUDY24070065

Details and patient eligibility

About

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

Full description

Over 18 million Americans are living with cancer. Half of them report clinically significant levels of depression, pain, and/or fatigue. According to the NIH consensus statement, these are the three most common and distressing cancer-related symptoms. These symptoms lead to poorer health-related quality of life (HRQoL) and cancer-related treatment adherence, higher unplanned health care utilization and costs, and reduced life expectancy.

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.

Enrollment: 1,750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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1,750 participants in 2 patient groups

CARES

Experimental group

Description:

Integrated Screening and Stepped Collaborative Care Intervention

Treatment:

Behavioral: CARES

Standard of Care (SOC)

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard of Care (SOC)