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

NCT03988543 | Completed DMC

• 1 other identifier: 1UM1CA233035-01
• Study Type: interventional
• Target: 4,104
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer

Keywords

Curative Intent; Non-curative Intent; Survivorship Care

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Patient clinical outcome of cancer recurrence (i.e., cancer has come back)

  Cancer recurrance at 12 months

• Patient clinical outcome of cancer progression (i.e., cancer has becomes worse)

  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 at 12 months

• Overall Survival (i.e., the time from study randomization until death due to any cause)

  Overall survival at 12 months (or end of study)

Study Arms (2)

Usual Care

NO INTERVENTION

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

Enhanced Care

EXPERIMENTAL

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

Behavioral: Patient Self-management

Interventions

Patient Self-management 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.

Also known as: Patient Engagement

Enhanced Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead
• Northwestern Medicine: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

• Nolla KM, Kuharic M, Lancki N, Walsh-Bailey CL, Flores AM, Garcia SF, Jensen RE, Wang Y, Mai Q, Mercer AM, Smith JD, Psihogios AM, Webster KA, Kircher SM, Franklin PD, Cella D, Yanez BR. Patient Portal Engagement in Oncology: Results From the NU IMPACT Study in a Large Health Care System. JCO Clin Cancer Inform. 2025 Dec;9:e2500178. doi: 10.1200/CCI-25-00178. Epub 2025 Dec 10.

  PMID: 41370780 DERIVED

• Smith JD, Bedjeti K, Lancki N, Sloss EA, Merle JL, Kircher S, Coughlin A, Metzger S, Webster KA, O'Connor M, Cahue S, Flores AM, Mai Q, Yanez B, Bass M, Jensen RE, Smith AW, Carroll AJ, Barnard C, George CM, Tsarwhas DG, Richardson K, Penedo FJ, Hemming K, Garcia SF, Scholtens DM, Cella D. Implementation outcomes of a symptom management intervention in ambulatory oncology practices evaluated using a cluster randomized stepped-wedge trial design. Implement Sci. 2025 Dec 2. doi: 10.1186/s13012-025-01475-y. Online ahead of print.

  PMID: 41331816 DERIVED

• Kuharic M, Merle JL, Cella D, Mitchell SA, DiMartino L, Ridgeway JL, Dizon DS, Paudel R, Austin JD, Wong SL, Flores AM, Cheville AL, Smith JD; IMPACT Consortium. Psychometric evaluation of the NoMAD instrument in cancer care settings: assessing factorial validity, measurement invariance, and differential item functioning. Implement Sci Commun. 2025 Jun 16;6(1):72. doi: 10.1186/s43058-025-00756-3.

  PMID: 40524282 DERIVED

• Cella D, Lancki N, Kuharic M, Yanez B, Bass M, Garcia MG, Webster KA, Smith JD, O'Connor M, Coughlin A, Cahue S, Kircher S, Flores AM, Penedo FJ, Jensen RE, Wilder Smith A, Richardson K, Barnard C, George CM, Tsarwhas DG, Scholtens D, Garcia SF. Web-Based Cancer Symptom Self-Management System: A Randomized Clinical Trial. JAMA Netw Open. 2025 May 1;8(5):e258353. doi: 10.1001/jamanetworkopen.2025.8353.

  PMID: 40323601 DERIVED

• Cella D, Garcia SF, Cahue S, Smith JD, Yanez B, Scholtens D, Lancki N, Bass M, Kircher S, Flores AM, Jensen RE, Smith AW, Penedo FJ. Implementation and evaluation of an expanded electronic health record-integrated bilingual electronic symptom management program across a multi-site Comprehensive Cancer Center: The NU IMPACT protocol. Contemp Clin Trials. 2023 May;128:107171. doi: 10.1016/j.cct.2023.107171. Epub 2023 Mar 28.

  PMID: 36990275 DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

• David Cella, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Medical Social Sciences

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: June 17, 2019
• Study Start: September 28, 2020
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: November 27, 2024

Record last verified: 2024-11

Locations

US (1)