Hybrid Type I Effectiveness-implementation Cluster Randomized Controlled Trial of CARES
Purpose
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
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Cluster Randomized Controlled Trial
- Primary Purpose
- Supportive Care
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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 |
|
Recruiting Locations
Pittsburgh, Pennsylvania 15213
More Details
- Status
- Recruiting
- Sponsor
- University of Pittsburgh
Detailed 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.