Enhanced, EHR-facilitated Cancer Symptom Control Pragmatic Clinical Trial

Study Overview
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Brief Summary
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This early phase I trial investigates enhanced, electronic health record (EHR)-facilitated cancer system control. Cancer and its treatment are often associated with severe, disabling symptoms that have been causally linked to diminished survival, increased healthcare utilization, degraded quality of life, unemployment, and non-adherence to recommended cancer treatments. Collaborative case management for control of moderate or worse sleep disturbance, pain, anxiety, depression, fatigue (SPADE symptoms), and physical dysfunction among cancer survivors and patients with cancer may improve quality of life, symptom severity, and adherence to cancer treatment, and may also reduce need for acute care.

Detailed Description
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PRIMARY OBJECTIVES: I. Conduct a cluster randomized pragmatic trial with a stepped wedge design to test the hypothesis that a symptom control-focused enhanced, electronic health record (EHR)-facilitated cancer symptom control (E2C2) intervention will significantly reduce sleep disturbance, pain, anxiety, depression, fatigue (SPADE) symptom and physical dysfunction scores, reduce unplanned hospitalizations and emergency department visits, improve adherence to cancer therapies, and improve self-reported quality of life. II. Evaluate the hypothesis that use of a multifaceted, evidence-based implementation strategy to support adoption and use of the E2C2 system will result in improvements in implementation and clinical outcomes. III. Conduct a mixed methods evaluation to detect, understand and reduce disparities in the adoption and implementation of the E2C2 intervention among elderly and rural-dwelling patients with cancer. OUTLINE: Patients randomized to E2C2 intervention participate in an interview over 30-45 minutes. Providers and stakeholders also participate in an interview over 15-30 minutes.

Official Title
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Enhanced, EHR-Facilitated Cancer Symptom Control (E2C2) Trial

Conditions
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Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

Intervention / Treatment
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* Other: Interview
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being seen for a solid or liquid cancer at a Midwest Mayo Clinic Midwest Mayo Clinic Health Systems (MCHS) site or for a solid tumor at Mayo Clinic Rochester Exclusion Criteria: No Minors (under age 18) will receive the questionnaires but no further exclusions can be made based on the standard of care for questionnaire assignment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (interview)<br>Patients randomized to E2C2 intervention participate in an interview over 30-45 minutes. Providers and stakeholders also participate in an interview over 15-30 minutes. | Other: Interview<br>* Participate in interview<br>Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep disturbance, pain, anxiety, depression, fatigue (SPADE) symptom scores | Measured by 11-point Numeric Rating Scale (NRS) every 30 days, up to 12 Months after last assessment | Up to 12 Months after last assessment | 
| Physical function numerical rating scale (NRS) scores | Measured by 11-point Numeric Rating Scale (NRS) every 30 days, up to 12 Months after last assessment | Up to 12 Months after last assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Measured PROMIS-CAT up to every four months, depending on visit frequency, for 12 months after last assessment | Up to 12 Months after last assessment | 
| Depression | Measured PROMIS-CAT up to every four months, depending on visit frequency, for 12 months after last assessment | Up to 12 Months after last assessment | 
| Average Pain Interference over the past week | Measured PROMIS-CAT up to every four months, depending on visit frequency, for 12 months after last assessment | Up to 12 Months after last assessment | 
| Physical function | Measured PROMIS-CAT up to every four months, depending on visit frequency, for 12 months after last assessment | Up to 12 Months after last assessment | 
| Health care utilization | ER visits & hospitalizations | Up to 12 Months after last assessment | 
| Adherence to cancer treatment | Examine frequency of missed imaging, medical oncology clinic visits, and chemotherapy appointments and capture any unplanned hiatuses in cancer treatment or dose reductions | Up to 12 Months after last assessment | 
| Vital Status | Vital status as determined by Accurint record search across multiple sources, including the Social Security Death Index | Up to 12 Months after last assessment/until 4 months after completion of intervention delivery |