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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA296402 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The trial will examine the effectiveness and facilitators and barriers of implementation of CARES, an integrated screening and stepped collaborative care intervention
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CARES | Experimental | Integrated Screening and Stepped Collaborative Care Intervention |
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| Standard of Care (SOC) | Active Comparator | Integrated screening and referred to treatment in the community and/or at the cancer center |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CARES | Behavioral | Integrated screening and stepped collaborative care |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Enrollment to the end of study for participant (12 months). The 12 months outcome will be a measure of maintenance of benefits. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 | Depressive Symptoms. A higher score reflecting more severe depressive symptoms (range of scores 0-27) | Screening to baseline and baseline to 12 months. The primary outcome will be at 6-months. |
| Brief Pain Inventory. |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Adverse Childhood Events | Adverse events in childhood. The total score ranges from 0-16. A higher score reflects a greater number of early adverse events. | The questionnaire will only be administered at baseline |
| Sociodemographic factors |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jennifer L Steel, PhD | Contact | 14126922041 | Steejl@upmc.edu | |
| Jennifer L Steel | Contact | 4126922041 | steejl@upmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jennifer L Steel, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center (UPMC) Cancer Center | Recruiting | Pittsburgh | Pennsylvania | 15213 | United States |
The data will be placed in data repository
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After final outcomes are reported in published format
Qualified researchers with aims and hypotheses that are approved by the study team
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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Cluster Randomized Controlled Trial
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| Standard of Care (SOC) |
| Behavioral |
Screening and referral of patient to provider in the community or cancer center |
|
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.
| Screening to baseline and baseline to 12 months. The primary outcome will be from baseline to 6-months |
| Generalized Anxiety Disorder -7 | Anxiety. The total score ranges from 0-21. A higher score indicates higher levels of anxiety. | Screening to baseline and baseline to 12 months. The primary time point is from baseline to 6 months. |
| FACIT Fatigue | Fatigue. A total score ranges from 0-52. A higher score indicates less fatigue. | Baseline to 12 months. The primary time point will be 6 months. |
| PROMIS Depression | Depressive symptoms. The range is from a T scores of 0-100 with a higher score reflecting higher levels of depressive symptoms. | 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 | 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. | Baseline to 12 months. |
| Fatigue Assessment Scale | Fatigue. The total score ranges from 10 to 50. A higher score reflects more severe fatigue. | 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 | Pain Severity. Total score ranges from 0-100. A higher score reflects higher levels of pain. | 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 | 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. | Enrollment to the end of study for participant (12 months). The primary time point is 6-months. |
| Interpersonal Support Evaluation List | 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). | Enrollment to the end of study for participant (12 months). The primary time point is 6-months. |
| Patient Health Questionnaire-9 | Depressive Symptoms. Scores range from 0-27 with a higher score reflecting higher levels of depressive symptoms | Screening to baseline and baseline to 12 months. The 12 months outcome will be a measure of maintenance of benefits. |
| Brief Pain Inventory. | 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. | Screening to baseline and baseline to 12 months. The 12 month PEG score will reflect maintenance of treatment. |
| Generalized Anxiety Disorder -7 | Anxiety. The total score ranges from 0-21. A higher score indicates higher levels of anxiety. | Screening to baseline and baseline to 12 months. The 12 months time point will assess maintenance of change. |
| FACIT Fatigue | Fatigue. A total score ranges from 0-52. A higher score indicates less fatigue. | Enrollment to the end of study for participant (12 months). The 12 months time point will reflect maintenance of change in fatigue. |
| COST | Financial toxicity. The range of scores is from 0-44 and a higher scores reflects a better financial well being. | Enrollment to the end of study for participant (12 months). The primary time point will be at 12 months. |
| Cost Coping | 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. | 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) | 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. | Enrollment to the end of study for participant (12 months). The primary time point is 12 months. |
| Cost Assessment | Health Care Utilization. There is no total score for this questionnaire as it will be used to estimate costs. | Enrollment to the end of study for participant (12 months). The primary time point is 12 months. |
| PROMIS Depression | Depressive symptoms. The range is from 0-100 with a higher score reflecting higher levels of depressive symptoms. | 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 | Anxiety. Scores range from 0-100 and a higher score reflects worse anxiety. | Enrollment to the end of study for participant (12 months). The 12 months time point is to assess maintenace of change. |
| Fatigue Assessment Scale | Fatigue. The total score ranges from 10 to 50. A higher score reflects more severe fatigue. | Enrollment to the end of study for participant (12 months). The 12 months time point will assess maintenance of change. |
| Pain Visual Analog Scale | Pain Severity. Total score ranges from 0-100. A higher score reflects higher levels of pain. | 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 | 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. | 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 | 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). | Enrollment to the end of study for participant (12 months). The 12-month time point will assess maintenance of change |
| Activity Based Costs | Health care costs. Range could be 0 to 10 million dollars | Enrollment to the end of study for participant (12 months). The primary time point is 12 months. |
| Adherence to outpatient appointment | Adherence to outpatient appointments. Percent of appointments missed out of total appointment in 12 months. | Enrollment to the end of study for participant (12 months). The primary time point is 12 months. |
| Complications | Number of complications from procedures or surgeries during 12 months post randomization. The primary time point is 12 months. | Baseline to 12 months |
| Length of Stay in the Hospital | Number of days patient was in the hospital. The primary end point is 12 months | Baseline to 12 months |
| Emergency Room Visits | Number of emergency room visits in 12 months post-randomization. The primary end point is 12 months | 12 months |
| 30-day readmissions | Unplanned readmission to the hospital after a procedure or surgery within 30 days. Primary end point 12 months | Baseline to 12 months |
| 90-day readmission | Unplanned readmission to the hospital after a procedure or surgery within 90 days. The primary endpoint is 12 months | Baseline to 12 months |
| PROMIS Fatigue | 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 | Screening to baseline and baseline to 12 months |
| PROMIS Fatigue | Assesses fatigue in cancer patients. Higher score reflects greater fatigue. Score range from a T score 0-100. Secondary endpoint 12 months | Screening to baseline and baseline to 12 months |
Sociodemographic characteristics of patient (e.g., age, sex, race, ethnicity, etc). No total score.
| Administered at baseline only. |
| Adherence to experimental treatment | Patient adherence to intervention. Reported as percent completed out of prescribed number of sessions (6-24). | Baseline to 12 months |
| Adherence to Boosters | Number of booster sessions completed. | Baseline to 12 months |
| Adherence to home practice | Patient adherence to intervention. Reported as percent completed. | Enrollment to end of study (12 months). |
| Height | Height in inches | Baseline through 12 months |
| Weight | Weight in pounds | Baseline to 12 months |
| Body Mass Index | 703 x weight x height x 2 | Baseline to 12 months |
| Psychiatric diagnoses | The measure will provide information that is self-reported by the patient about any new diagnoses (e.g., depression, anxiety). No total score. Frequency of psychiatric diagnoses | Baseline to 12 months |
| Psychiatric or Psychological Treatments | The treatments the person may have sought (e.g., counseling, medication, support group, pain clinic, palliative care). No total score. Frequency of treatments patients sought for symptoms | Baseline to 12 months |
| Patient cancer diagnosis | Patient cancer diagnoses | Baseline to 12 months |
| Cancer treatments | Past cancer treatments (e.g., surgery, chemotherapy, immunotherapy). No total score. Frequency of treatments. | Prior treatments before baseline and baseline to 12 months |
| Stage of Cancer | Stage of cancer | at diagnosis and changes from baseline to 12 months |
| Routine laboratory values | Routine laboratory values (e.g., CEA, WBC, RBC) | Baseline 12 months |
| Medical comorbities | Medical comorbidities (e.g., hypertension, diabetes). Total number and Charlson Comorbidly Index | Prior to baseline and baseline to 12 months |
| Medications | Medications (e.g., antihypertensives, antidepressants). Number of medications, dose of medication, type of medication, and prescriber | Prior to baseline and baseline to 12 months |
| Disease progression | Disease progression. Measured by Complete response, partial response, disease progression, or stable disease | Baseline to 12 months |
| Residential Segregation | Segregation as measured by publicly available resources and mapped based on the United States Census geographic identifiers | Baseline to 12 months |
| Gini Index | Income inequality measured using publicly available resources and mapped based on the United States Census geographic identifiers | Baseline to 12 months |
| National Walkability | Walkability of neighborhood based on publicly available resources and mapped based on the United States Census geographic identifiers | Baseline to 12 months |
| Area Deprivation Index | Socioeconomic disadvantage as measured by publicly available resources and mapped based on the United States Census geographic identifiers | Baseline to 12 months |
| Rural Urban Continuum Code | Measure of the rural versus urban residence. Measured using publicly available resources and mapped based on the United States Census geographic identifiers | Baseline to 12 months |
| Intervention Delivery | How the intervention was delivered (e.g., phone, videoconference, face to face) | Baseline to 12 months |
| Patient location at time of intervention | Where the patient was located when receiving the intervention | Baseline to 12 months |
| Session Content | What session content the patient received (e.g., monitoring automatic thoughts, sleep hygiene, energy conservation strategies). | Baseline to 12 months |
| Homework completion | Where and what homework was completed. Number of homework assignments and location of completion (e.g., home or in session) | Baseline to 12 months |
| Patient engagement with intervention content | Therapists' ratings of patient engagement with the session material. 7 point Likert scale | Baseline to 12 months |
| Patient engagement with homework | Therapist reported patient engagement with homework. Likert scale 1-7 | Baseline to 12 months |
| Patient-Therapist Rapport | Therapist rating of patient-therapist rapport. 1-7 Likert Scale | Baseline to 12 months |
| Crisis intervention | Number of patients reporting suicidal ideation and plan during screening and treatment. Number of patients requiring crisis intervention. | Screening to 12 months |
| Change in Medication for Symptoms | Initiation or change in medication dose, frequency, type, and health care provider who changed or initiated medication as reported by the patient and verified by medical record. | Baseline to 12 months |
| Symptoms at Screening | The number of patients who screened negative and positive for anxiety, depressive symptoms, fatigue, and pain | Screening to 12 months |