Cancer, and cancer treatment, cause many symptoms that can adversely 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 integrated cancer symptom monitoring and management
system (NMPRO), currently deployed by our health care delivery system. We will test the effectiveness of a
system-wide symptom management intervention when implemented across the Northwestern Memorial
HealthCare Corporation (NMHC) outpatient oncology clinics. Using a clinic-level randomized roll-out
implementation trial design, we will further test, using an embedded patient-level randomized controlled clinical
trial, 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 NMPRO will constitute
usual care (UC), and added patient engagement and activation features will comprise the EC condition. This
innovative hybrid trial design allows for a within- and between-site evaluation of implementation along with a
sufficiently powered group-based comparison to demonstrate effectiveness on individual patient outcomes.
We propose three specific aims that 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
PROMIS® computerized adaptive tests (CATs). In addition, we will assess patient clinical outcomes, including
healthcare utilization, and cancer treatment delivery outcomes. The NU IMPACT study design allows joint
evaluation of system-level implementation and patient-level effectiveness metrics. An extensive array of
longitudinal EHR data will be integrated using custom informatics tools and deployed for statistical analysis
using plans that blend psychometric and biostatistical outcome evaluation models. Successful elements of this
intervention approach will then be extended to widespread adoption.
