NCT03988543: NU IMPACT

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

Completed NA Last updated 27 November 2024

What this trial tests

NA trial testing Patient Self-management in Cancer in 4,104 participants. Completed in 15 May 2024.

Timeline

28 September 2020

Primary endpoint
15 May 2024

15 May 2024

Quick facts

Lead sponsor	Northwestern University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	4,104
Start date	28 September 2020
Primary completion	15 May 2024
Estimated completion	15 May 2024
Sites	1 location across United States

Drugs / interventions tested

• Patient Self-management

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

Northwestern University

Who can join

18 and older, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. 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.
   Cella D, Garcia SF, Cahue S, Smith JD, et al · · 2023 · cited 21× · PMID 36990275 · DOI 10.1016/j.cct.2023.107171
2. Systematic symptom management in the IMPACT Consortium: rationale and design for 3 effectiveness-implementation trials.
   Smith AW, DiMartino L, Garcia SF, Mitchell SA, et al · · 2023 · cited 15× · PMID 37930033 · DOI 10.1093/jncics/pkad073
3. Web-Based Cancer Symptom Self-Management System: A Randomized Clinical Trial.
   Cella D, Lancki N, Kuharic M, Yanez B, et al · · 2025 · cited 7× · PMID 40323601 · DOI 10.1001/jamanetworkopen.2025.8353
4. Psychometric evaluation of the NoMAD instrument in cancer care settings: assessing factorial validity, measurement invariance, and differential item functioning.
   Kuharic M, Merle JL, Cella D, Mitchell SA, et al · · 2025 · cited 3× · PMID 40524282 · DOI 10.1186/s43058-025-00756-3
5. Statistical analysis plan for the NU IMPACT stepped-wedge cluster randomized trial.
   Scholtens DM, Lancki N, Hemming K, Cella D, et al · · 2024 · cited 3× · PMID 38852769 · DOI 10.1016/j.cct.2024.107603
6. Patient Portal Engagement in Oncology: Results From the NU IMPACT Study in a Large Health Care System.
   Nolla KM, Kuharic M, Lancki N, Walsh-Bailey CL, et al · · 2025 · PMID 41370780 · DOI 10.1200/cci-25-00178
7. Implementation outcomes of a symptom management intervention in ambulatory oncology practices evaluated using a cluster randomized stepped-wedge trial design.
   Smith JD, Bedjeti K, Lancki N, Sloss EA, et al · · 2025 · PMID 41331816 · DOI 10.1186/s13012-025-01475-y