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

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.

• Patient Health Questionnaire-9 [Time frame: Screening to baseline and baseline to 12 months. The primary outcome will be at 6-months.]
• Brief Pain Inventory. [Time frame: Screening to baseline and baseline to 12 months. The primary outcome will be from baseline to 6-months]
• Generalized Anxiety Disorder -7 [Time frame: Screening to baseline and baseline to 12 months. The primary time point is from baseline to 6 months.]
• FACIT Fatigue [Time frame: Baseline to 12 months. The primary time point will be 6 months.]
• PROMIS Depression [Time frame: 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).]
• PROMIS Anxiety [Time frame: Baseline to 12 months.]
• Fatigue Assessment Scale [Time frame: Enrollment to the end of study for participant (12 months). The primary time point is 6 months. The questionnaire will also be used for treatment response 0-24 weeks (every 4 weeks).]
• Pain Visual Analog Scale [Time frame: Baseline to 12 months. The 6 month time point is primary. The questionnaire will also be used for treatment response 0-24 weeks (every 4 weeks) and then for the booster session at the end of treatment up until 12 months.]
• Pittsburgh Sleep Quality Index [Time frame: Enrollment to the end of study for participant (12 months). The primary time point is 6-months.]
• Interpersonal Support Evaluation List [Time frame: Enrollment to the end of study for participant (12 months). The primary time point is 6-months.]
• Patient Health Questionnaire-9 [Time frame: Screening to baseline and baseline to 12 months. The 12 months outcome will be a measure of maintenance of benefits.]
• Brief Pain Inventory. [Time frame: Screening to baseline and baseline to 12 months. The 12 month PEG score will reflect maintenance of treatment.]