Bilingual Electronic Symptom Management Program Across Multi-site, Comprehensive Cancer Center

Study Overview
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Brief Summary
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Cancer, and cancer treatment, cause many symptoms that can negatively affect quality of life. Despite the development of improved symptom management interventions and several evidence- and consensus-based guidelines, their timely delivery remains uneven in the health care system. Our research center, Northwestern University IMPACT (NU IMPACT), builds upon an electronic health record (EHR)-integrated cancer symptom monitoring and management system, currently deployed by our health care system. We are testing the effectiveness of a system-wide symptom management intervention and the EHR-integrated enhanced care approach, which offers a more personalized symptom monitoring and management experience based on a person's unique needs and language (i.e., English or Spanish).

Detailed Description
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Using a clinic-level randomized roll-out implementation trial design, we will test the effectiveness of an enhanced care (EC) approach aimed to engage participants actively, and to increase self-efficacy, in the monitoring and managing of their symptoms. The existing EHR-integrated symptom monitoring system will constitute usual care (UC), and added patient engagement and activation features will comprise the EC condition. Project aims target both patient- and system-level outcomes. Aim 1: Implement a fully-integrated oncology symptom assessment and management program across six clinical units that are part of the NMHC healthcare delivery system; Aim 2: Evaluate the impact of the program by conducting a hybrid Type I effectiveness-implementation trial to evaluate the enhanced care program (EC: symptom monitoring & self-management intervention), relative to usual care (UC) on patient- and system-level outcomes; Aim 3: Identify facilitators and barriers to implementation and disseminate to other health systems. We will enroll an estimated 12,671 participants. To address possible contamination effects within each clinical unit, and allow for unit-level data collection for pre- and post-implementation comparison within and across clinical units, 50% will be enrolled and followed prior to program implementation. The other half will be enrolled post-implementation and will be randomly assigned at a 1:1 ratio (stratified by sex and cancer phase; curative intent, non-curative intent & survivorship) to UC versus EC. Fatigue, pain, anxiety, and depression will be assessed using Patient Reported Outcome Measurement Information System (PROMIS®) computerized adaptive tests (CATs). In addition, we will assess patient clinical outcomes, including healthcare utilization, and cancer treatment delivery outcomes.

Official Title
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Implementation and Evaluation of an Expanded Bilingual Electronic Symptom Management Program Across a Multi-site, Fully-integrated Comprehensive Cancer Center

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Patient Self-management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Curative Intent Group: ≥ 18 years of age; medical chart confirmed diagnosis of a solid or hematological malignancy; willingness to be randomized (post-implementation only); have initiated primary treatment with curative intent within the past 3 months (i.e., as patients receive surgery, standard- or high-dose chemotherapy, biological therapy, and/or radiotherapy); provider confirmed planned treatment and follow-up within the Northwestern Medicine HealthCare (NMHC) hospital and clinics; able to read English or Spanish; and no evidence of dementia; severe psychopathology (i.e., inpatient psychiatric treatment within past 3-months) or visual or motor impairment that would prevent completion of study procedures. Non-Curative/Palliative Intent Group: ≥ 18 years of age; medical chart confirmed diagnosis of advanced or metastatic solid or hematological malignancy; willingness to be randomized (post-implementation only); undergoing cancer treatment with non-curative/palliative intent (e.g., patients with advanced or metastatic disease who receive chemotherapy, biological therapy, and/or radiotherapy to control or slow advance of their disease); provider confirmed planned treatment and follow-up within the NMHC hospital and clinics; able to read English or Spanish; and no evidence of dementia; severe psychopathology (i.e., inpatient psychiatric treatment within past 3-months) or visual or motor impairment that would prevent completion of study procedures. Cancer Survivorship Group: ≥ 18 years of age; medical chart confirmed diagnosis of solid or hematological malignancy within the past 2 years; willingness to be randomized (post-implementation only); completed active cancer treatment with curative intent, including those who may be receiving maintenance or prophylactic cancer treatment; provider confirmed planned follow-up (with or without treatment) within the NMHC e hospital and clinics; able to read English or Spanish; and no evidence of dementia; severe psychopathology (i.e., inpatient psychiatric treatment within past 3-months) or visual or motor impairment that would prevent completion of study procedures. Exclusion Criteria: -

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This trial design, in conjunction with our aims and measurement strategy, is consistent with a hybrid Type I effectiveness-implementation trial, which primarily tests the clinical effectiveness of an evidence-based intervention while secondarily documenting and evaluating its implementation. The randomized roll-out implementation trial design is in the same class as the commonly-used stepped wedge trial, but is more practical for real-world application due to lower measurement burden on clinics due to using incomplete wedges. To assess implementation at the level of the clinic, and control for patient-level outcome prior to implementation, we use a pragmatic randomized roll-out implementation trial design with an embedded patient-level randomized group-based comparison.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>Patients will receive current standard care of EHR-integrated symptom monitoring. | |
| Experimental: Enhanced Care<br>Patient will receive current standard care of EHR-integrated symptom monitoring, plus patient self-management intervention. | Behavioral: Patient Self-management<br>* Enhanced care (EC) approach aimed to engage participants actively, and to increase self-efficacy, in the monitoring and managing of their symptoms. After patients complete the current EHR-integrated symptom monitoring, they will receive web-based, patient-centered information to gain knowledge on cancer-related outcomes, improve self-management skills, improve communication skills, and empower them to improve motivation and self-management.<br>* Other names: Patient Engagement;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual-level change overtime related to cancer and cancer treatment symptoms | Symptom severity will be assessed using Patient-Reported Outcomes Measurement Information System (PROMIS) computer adaptive tests (CATs) related to symptoms of pain, fatigue, depression, anxiety, and physical function. CAT question items are dynamically selected for administration from an item bank based upon the respondent's previous answers. Patient usually completes 4-12 items with a high level of measurement precision for each domain. | Change from baseline adverse symptom severity at 12 months | 
| Adverse symptom severity related to cancer and cancer treatment | Adverse symptom severity will be assessed using Patient-Reported Outcomes- Common Terminology for Adverse Events (PRO-CTCAE™) assessment. The PRO-CTCAE questionnaire will ask about nausea, constipation, insomnia, vomiting, shortness of breath, and diarrhea. | Change from baseline PRO-CTCAE adverse event severity at 12 month | 
| Healthcare utilization by participant related to managing their cancer and cancer treatment | Participant utilization of healthcare services, such as number of emergency room visits, oncology urgent care visits, unscheduled doctor visits, doctor visits, hospital admissions and length of stay, and supportive care needs to manage their cancer and cancer treatment, will be assessed by electronic health records. | Change from baseline healthcare utilization at 12 months | 
| Patient Treatment Delivery Satisfaction | Patient satisfaction of their cancer-related care will be assessed using Consumer Assessment of Healthcare Providers and Systems (CAHPS) Cancer Care survey composite measures. | Change from baseline treatment delivery satisfaction at 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient clinical outcome of cancer recurrence (i.e., cancer has come back) | Cancer recurrence will be assessed by electronic health record diagnosis codes in patients in curative intent and survivorship groups. | Cancer recurrance at 12 months | 
| Patient clinical outcome of cancer progression (i.e., cancer has becomes worse) | Cancer progression will be assessed by electronic health records diagnosis codes in curative intent and non-curative intent groups. | Cancer progression at 12 months | 
| Patient clinical outcome of second cancer (i.e., completely new and a different type of cancer than the first one) | Second cancer will be assessed by patient medical record diagnosis codes in curative intent, non-curative intent, and survivorship groups. | Second cancer at 12 months | 
| Overall Survival (i.e., the time from study randomization until death due to any cause) | Overall survival will be assessed by electronic health records in the curative intent and non-curative intent groups. | Overall survival at 12 months (or end of study) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Curative Intent, Non-curative Intent, Survivorship Care