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

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

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

Depressive Symptoms. A higher score reflecting more severe depressive symptoms (range of scores 0-27)

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.

Anxiety. The total score ranges from 0-21. A higher score indicates higher levels of anxiety.

Fatigue. A total score ranges from 0-52. A higher score indicates less fatigue.

Depressive symptoms. The range is from a T scores of 0-100 with a higher score reflecting higher levels of depressive symptoms.

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. The total score ranges from 10 to 50. A higher score reflects more severe fatigue.

Pain Severity. Total score ranges from 0-100. A higher score reflects higher levels of pain.

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.

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).

Depressive Symptoms. Scores range from 0-27 with a higher score reflecting higher levels of depressive symptoms

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.

Anxiety. The total score ranges from 0-21. A higher score indicates higher levels of anxiety.

Fatigue. A total score ranges from 0-52. A higher score indicates less fatigue.

Financial toxicity. The range of scores is from 0-44 and a higher scores reflects a better financial well being.

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.

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.

Health Care Utilization. There is no total score for this questionnaire as it will be used to estimate costs.

Depressive symptoms. The range is from 0-100 with a higher score reflecting higher levels of depressive symptoms.

Anxiety. Scores range from 0-100 and a higher score reflects worse anxiety.

Fatigue. The total score ranges from 10 to 50. A higher score reflects more severe fatigue.

Pain Severity. Total score ranges from 0-100. A higher score reflects higher levels of pain.

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.

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).

Health care costs. Range could be 0 to 10 million dollars

Adherence to outpatient appointments. Percent of appointments missed out of total appointment in 12 months.

Number of complications from procedures or surgeries during 12 months post randomization. The primary time point is 12 months.

Number of days patient was in the hospital. The primary end point is 12 months

Number of emergency room visits in 12 months post-randomization. The primary end point is 12 months

Unplanned readmission to the hospital after a procedure or surgery within 30 days. Primary end point 12 months

Unplanned readmission to the hospital after a procedure or surgery within 90 days. The primary endpoint is 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

Assesses fatigue in cancer patients. Higher score reflects greater fatigue. Score range from a T score 0-100. Secondary endpoint 12 months

Adverse events in childhood. The total score ranges from 0-16. A higher score reflects a greater number of early adverse events.

Sociodemographic characteristics of patient (e.g., age, sex, race, ethnicity, etc). No total score.

Patient adherence to intervention. Reported as percent completed out of prescribed number of sessions (6-24).

Number of booster sessions completed.

Patient adherence to intervention. Reported as percent completed.

Height in inches

Weight in pounds

703 x weight x height x 2

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

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

Patient cancer diagnoses

Past cancer treatments (e.g., surgery, chemotherapy, immunotherapy). No total score. Frequency of treatments.

Stage of cancer

Routine laboratory values (e.g., CEA, WBC, RBC)

Medical comorbidities (e.g., hypertension, diabetes). Total number and Charlson Comorbidly Index

Medications (e.g., antihypertensives, antidepressants). Number of medications, dose of medication, type of medication, and prescriber

Disease progression. Measured by Complete response, partial response, disease progression, or stable disease

Segregation as measured by publicly available resources and mapped based on the United States Census geographic identifiers

Income inequality measured using publicly available resources and mapped based on the United States Census geographic identifiers

Walkability of neighborhood based on publicly available resources and mapped based on the United States Census geographic identifiers

Socioeconomic disadvantage as measured by publicly available resources and mapped based on the United States Census geographic identifiers

Measure of the rural versus urban residence. Measured using publicly available resources and mapped based on the United States Census geographic identifiers

How the intervention was delivered (e.g., phone, videoconference, face to face)

Where the patient was located when receiving the intervention

What session content the patient received (e.g., monitoring automatic thoughts, sleep hygiene, energy conservation strategies).

Where and what homework was completed. Number of homework assignments and location of completion (e.g., home or in session)

Therapists' ratings of patient engagement with the session material. 7 point Likert scale

Therapist reported patient engagement with homework. Likert scale 1-7

Therapist rating of patient-therapist rapport. 1-7 Likert Scale

Number of patients reporting suicidal ideation and plan during screening and treatment. Number of patients requiring crisis intervention.

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.

The number of patients who screened negative and positive for anxiety, depressive symptoms, fatigue, and pain