CARES, Standard of Care
Conditions
Keywords
implementation, stepped collaborative care, integrated screening and treatment, cluster randomized controlled trial, cancer, screening
Brief 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.
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
Sponsors
University of Pittsburgh
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Cluster Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional Assessment of Cancer Therapy-General | Enrollment to the end of study for participant (12 months). The primary time point is 6 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-9 | Screening to baseline and baseline to 12 months. The primary outcome will be at 6-months. | Depressive Symptoms. A higher score reflecting more severe depressive symptoms (range of scores 0-27) |
| Brief Pain Inventory. | Screening to baseline and baseline to 12 months. The primary outcome will be from baseline to 6-months | Pain intensity and interference. The Pain, Enjoyment, and General Activity score (0-10) will be used as the secondary outcome. A higher score reflects greater pain interference. |
| Generalized Anxiety Disorder -7 | Screening to baseline and baseline to 12 months. The primary time point is from baseline to 6 months. | Anxiety. The total score ranges from 0-21. A higher score indicates higher levels of anxiety. |
| FACIT Fatigue | Baseline to 12 months. The primary time point will be 6 months. | Fatigue. A total score ranges from 0-52. A higher score indicates less fatigue. |
| 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). | Depressive symptoms. The range is from a T scores of 0-100 with a higher score reflecting higher levels of depressive symptoms. |
| PROMIS Anxiety | Baseline to 12 months. | Anxiety. Scores range from a T score of 0-100 and a higher score reflects worse anxiety. Used for treatment response and primary endpoint 6 months. |
| Fatigue Assessment Scale | 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). | Fatigue. The total score ranges from 10 to 50. A higher score reflects more severe fatigue. |
| Pain Visual Analog Scale | 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. | Pain Severity. Total score ranges from 0-100. A higher score reflects higher levels of pain. |
| Pittsburgh Sleep Quality Index | Enrollment to the end of study for participant (12 months). The primary time point is 6-months. | Sleep problems. The total sleep quality (0-21) and subscales including the sleep duration (0-24), sleep disturbance (0-3), sleep latency (0-3), days of dysfunction (0-3), efficiency (0-3), overall sleep quality (0-3), medications to sleep (0-3). A higher score means more sleep problems. |
| Interpersonal Support Evaluation List | Enrollment to the end of study for participant (12 months). The primary time point is 6-months. | Social support. A higher score reflects better social support. The range of scores 0-48 with subscales including appraisal (0-16), belonging (0-16), and tangible (0-16). |
| COST | Enrollment to the end of study for participant (12 months). The primary time point will be at 12 months. | Financial toxicity. The range of scores is from 0-44 and a higher scores reflects a better financial well being. |
| Cost Coping | Enrollment to the end of study for participant (12 months). The primary time point will be 12 months. | Cost coping strategies. The total score is the number of cost coping strategies a patient uses to manage their financial costs associated with their medical care. The total number of cost coping strategies is 0-26. |
| EQ 5D 5L (this is the title of the instrument there is no non abbreviated title) | Enrollment to the end of study for participant (12 months). The primary time point is 12 months. | Health related quality of life. Total score ranges from 0-25 for part 1 and 0 to 100 for part 2. A higher score reflects a better quality of life. |
| Cost Assessment | Enrollment to the end of study for participant (12 months). The primary time point is 12 months. | Health Care Utilization. There is no total score for this questionnaire as it will be used to estimate costs. |
| Activity Based Costs | Enrollment to the end of study for participant (12 months). The primary time point is 12 months. | Health care costs. Range could be 0 to 10 million dollars |
| Adherence to outpatient appointment | Enrollment to the end of study for participant (12 months). The primary time point is 12 months. | Adherence to outpatient appointments. Percent of appointments missed out of total appointment in 12 months. |
| Complications | Baseline to 12 months | Number of complications from procedures or surgeries during 12 months post randomization. The primary time point is 12 months. |
| Length of Stay in the Hospital | Baseline to 12 months | Number of days patient was in the hospital. The primary end point is 12 months |
| Emergency Room Visits | 12 months | Number of emergency room visits in 12 months post-randomization. The primary end point is 12 months |
| 30-day readmissions | Baseline to 12 months | Unplanned readmission to the hospital after a procedure or surgery within 30 days. Primary end point 12 months |
| 90-day readmission | Baseline to 12 months | Unplanned readmission to the hospital after a procedure or surgery within 90 days. The primary endpoint is 12 months |
| PROMIS Fatigue | Screening to baseline and baseline to 12 months | Assesses fatigue in cancer patients. Higher score reflects greater fatigue. Score range from a T score 0-100. Primary end point baseline to 6 months |
Countries
United States
Contacts
CONTACTJennifer L Steel, PhD
CONTACTJennifer L Steel
PRINCIPAL_INVESTIGATORJennifer L Steel, PhD
University of Pittsburgh
Outcome results
None listed