Clinical trial · Interventional
Bilingual Electronic Symptom Management Program Across Multi-site, Comprehensive Cancer Center
Implementation and Evaluation of an Expanded Bilingual Electronic Symptom Management Program Across a Multi-site, Fully-integrated Comprehensive Cancer Center
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient Self-management | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Usual Care
- description
- Patients will receive current standard care of EHR-integrated symptom monitoring.
- type
- EXPERIMENTAL
- label
- Enhanced Care
- description
- Patient will receive current standard care of EHR-integrated symptom monitoring, plus patient self-management intervention.
- interventionNames
- Behavioral: Patient Self-management
Primary outcomes (4)
- measure
- Individual-level change overtime related to cancer and cancer treatment symptoms
- timeFrame
- Change from baseline adverse symptom severity at 12 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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: \-
References
Publications (6)
- DERIVEDNolla 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
- DERIVEDSmith 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;21(1):10. doi: 10.1186/s13012-025-01475-y. PMID 41331816
- DERIVEDKuharic 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
- DERIVEDCella 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
- DERIVEDScholtens DM, Lancki N, Hemming K, Cella D, Smith JD. Statistical analysis plan for the NU IMPACT stepped-wedge cluster randomized trial. Contemp Clin Trials. 2024 Aug;143:107603. doi: 10.1016/j.cct.2024.107603. Epub 2024 Jun 8. PMID 38852769