Hybrid Type I Effectiveness-Implementation Cluster Randomized Trial of CARES
Summary
The trial will examine the effectiveness and facilitators and barriers of implementation of CARES, an integrated screening and stepped collaborative care intervention
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.
Arms & interventions
- BehavioralCARES
Integrated screening and stepped collaborative care
- BehavioralStandard of Care (SOC)
Screening and referral of patient to provider in the community or cancer center
Outcome measures
Primary
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
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
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
Time frame: Enrollment to the end of study for participant (12 months). The 12 months outcome will be a measure of maintenance of benefits.
Secondary
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.
Generalized Anxiety Disorder -7
Time frame: Screening to baseline and baseline to 12 months. The 12 months time point will assess maintenance of change.
FACIT Fatigue
Time frame: Enrollment to the end of study for participant (12 months). The 12 months time point will reflect maintenance of change in fatigue.
COST
Time frame: Enrollment to the end of study for participant (12 months). The primary time point will be at 12 months.
Cost Coping
Time frame: Enrollment to the end of study for participant (12 months). The primary time point will be 12 months.
EQ 5D 5L (this is the title of the instrument there is no non abbreviated title)
Time frame: Enrollment to the end of study for participant (12 months). The primary time point is 12 months.
Cost Assessment
Time frame: Enrollment to the end of study for participant (12 months). The primary time point is 12 months.
PROMIS Depression
Time frame: Enrollment to the end of study for participant (12 months). The 12 month time point will be used to assess maintenance of change.
PROMIS Anxiety
Time frame: Enrollment to the end of study for participant (12 months). The 12 months time point is to assess maintenace of change.
Fatigue Assessment Scale
Time frame: Enrollment to the end of study for participant (12 months). The 12 months time point will assess maintenance of change.
Pain Visual Analog Scale
Time frame: Enrollment to the end of study for participant (12 months). The 12 months time point is to assess maintenance of change.
Pittsburgh Sleep Quality Index
Time frame: Enrollment to the end of study for participant (12 months). The 12 months time point is to assess maintenance of change.
Interpersonal Support Evaluation List
Time frame: Enrollment to the end of study for participant (12 months). The 12-month time point will assess maintenance of change
Activity Based Costs
Time frame: Enrollment to the end of study for participant (12 months). The primary time point is 12 months.
Adherence to outpatient appointment
Time frame: Enrollment to the end of study for participant (12 months). The primary time point is 12 months.
Complications
Time frame: Baseline to 12 months
Length of Stay in the Hospital
Time frame: Baseline to 12 months
Emergency Room Visits
Time frame: 12 months
30-day readmissions
Time frame: Baseline to 12 months
90-day readmission
Time frame: Baseline to 12 months
PROMIS Fatigue
Time frame: Screening to baseline and baseline to 12 months
PROMIS Fatigue
Time frame: Screening to baseline and baseline to 12 months
Eligibility criteria
Study locations (1)
University of Pittsburgh Medical Center (UPMC) Cancer Center
Pittsburgh, Pennsylvania, 15213