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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

4104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-28

Study Completion Date

2024-05-15

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).

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual Care

Patients will receive current standard care of EHR-integrated symptom monitoring.

Group Type NO_INTERVENTION

No interventions assigned to this group

Enhanced Care

Patient will receive current standard care of EHR-integrated symptom monitoring, plus patient self-management intervention.

Group Type EXPERIMENTAL

Patient Self-management

Intervention Type BEHAVIORAL

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.

Interventions

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Patient Self-management

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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Patient Engagement

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.