Clinical trial NCT03988543: Bilingual Electronic Symptom Management Program Across Multi-site, Comprehensive Cancer Center
Official title: Implementation and Evaluation of an Expanded Bilingual Electronic Symptom Management Program Across a Multi-site, Fully-integrated Comprehensive Cancer Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Curative Intent
Non-curative Intent
Survivorship Care
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Northwestern Medicine
name: National Cancer Institute (NCI)
First posted: 2019-06-17
Enrollment: 4104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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:

-

Primary outcomes:
measure: Individual-level change overtime related to cancer and cancer treatment symptoms
timeFrame: Change from baseline adverse symptom severity at 12 months
measure: Adverse symptom severity related to cancer and cancer treatment
timeFrame: Change from baseline PRO-CTCAE adverse event severity at 12 month
measure: Healthcare utilization by participant related to managing their cancer and cancer treatment
timeFrame: Change from baseline healthcare utilization at 12 months
measure: Patient Treatment Delivery Satisfaction
timeFrame: Change from baseline treatment delivery satisfaction at 12 months
Secondary outcomes:
measure: Patient clinical outcome of cancer recurrence (i.e., cancer has come back)
timeFrame: Cancer recurrance at 12 months
measure: Patient clinical outcome of cancer progression (i.e., cancer has becomes worse)
timeFrame: Cancer progression at 12 months
measure: Patient clinical outcome of second cancer (i.e., completely new and a different type of cancer than the first one)
timeFrame: Second cancer at 12 months
measure: Overall Survival (i.e., the time from study randomization until death due to any cause)
timeFrame: Overall survival at 12 months (or end of study)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
Study officials:
affiliation: Northwestern University
name: David Cella, PhD
role: PRINCIPAL_INVESTIGATOR
References: