Clinical trial · Observational
Chronic Lymphocytic Leukemia Electronic Patient Reported Outcomes Study
The Roles of Education and Patient Engagement to Improve Symptom Management and the Quality of Life for Patients With Chronic Lymphocytic Leukemia
- 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)
This multi-site study will enroll approximately 100 CLL patients across 5 cancer institutions. The aim of the project is to ensure hematology care teams that are participating in new value-based reimbursement models have an accurate understanding of the evidence and roles of new therapies for CLL and best practice supportive care protocols to proactively assess, monitor, and manage symptoms to promote successful clinical outcomes. Hematology teams at seven health systems across the U.S. will be given online clinical training on the latest evidence for treatment planning in CLL along with best supportive care practices for patients on novel CLL treatments, prior to using Carevive's patient engagement software. Once training is complete, the Carevive software will be employed in the clinic whereby CLL patients will use the Carevive patient portal to report any symptoms at and in between clinic visits. Patients will be given a user name and password to a web-based portal for 24/7 reporting of symptoms experienced. Patient-reported and clinical data will be processed by the Carevive rules engine technology to generate evidence-based supportive care plans providing patients with direction regarding self-management strategies, care coordination for relevant cancer center services, and direction on when to go to the emergency department (ED) or call their hematologist based on their institution's protocol. For patients who require ongoing and routine monitoring, such supportive care recommendations will be included in supportive care plans generated at the clinic visit. On the visits subsequent to the delivery of the care plan, patients will report on the perceived effectiveness of the intervention (or barriers to non-adherence to the intervention). Patients and clinicians will assess symptom severity at each visit for a 16-week period and both data sets will be stored and analyzed for research purposes.
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 |
|---|---|---|---|
| CLL | Chronic Lymphocytic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Carevive CPS | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Patient perception of the overall effectiveness, acceptability, and usability of bi-directional web-based technology to self-report symptom prevalence and severity and receive management recommendations
- timeFrame
- Year 1
- description
- Patients will be asked to rate how acceptable, effective, and usable the web-based technology was using a 5-item system usability measure. The data will then be analyzed in order to describe the patient perceptions of the intervention
- measure
- Longitudinal symptom experience of patients with CLL
- timeFrame
- Year 1
- description
- Data collected on the Carevive CPS using the PRO-CTCAE and ESASr tools will be analyzed in order to describe the longitudinal symptom experience
Secondary outcomes (2)
- measure
- ER utilization and hospitalization in elderly patients with CLL
- timeFrame
- Year 1
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * All participants must be 18 years of age or older. * Patient participants must have a diagnosis of CLL, and either be on active treatment or need first-line treatment. * Patient participants must be able to access a web-based portal. * All participants must be able to understand English. Exclusion Criteria * Any patient who cannot understand written or spoken English. * Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C, and D). The inclusion and exclusion criteria above will be used to screen for eligibility of all patients.
References
Publications (5)
- BACKGROUNDBrown JR, Hallek MJ, Pagel JM. Chemoimmunotherapy Versus Targeted Treatment in Chronic Lymphocytic Leukemia: When, How Long, How Much, and in Which Combination? Am Soc Clin Oncol Educ Book. 2016;35:e387-98. doi: 10.1200/EDBK_159018. PMID 27249745
- BACKGROUNDCramer P, Hallek M, Eichhorst B. State-of-the-Art Treatment and Novel Agents in Chronic Lymphocytic Leukemia. Oncol Res Treat. 2016;39(1-2):25-32. doi: 10.1159/000443903. Epub 2016 Jan 22. PMID 26890007
- BACKGROUNDKolodziej M, Hoverman JR, Garey JS, Espirito J, Sheth S, Ginsburg A, Neubauer MA, Patt D, Brooks B, White C, Sitarik M, Anderson R, Beveridge R. Benchmarks for value in cancer care: an analysis of a large commercial population. J Oncol Pract. 2011 Sep;7(5):301-6. doi: 10.1200/JOP.2011.000394. PMID 22211126
- BACKGROUNDTucci A, Ferrari S, Bottelli C, Borlenghi E, Drera M, Rossi G. A comprehensive geriatric assessment is more effective than clinical judgment to identify elderly diffuse large cell lymphoma patients who benefit from aggressive therapy. Cancer. 2009 Oct 1;115(19):4547-53. doi: 10.1002/cncr.24490. PMID 19562776
- BACKGROUNDBellera C, Praud D, Petit-Moneger A, McKelvie-Sebileau P, Soubeyran P, Mathoulin-Pelissier S. Barriers to inclusion of older adults in randomised controlled clinical trials on Non-Hodgkin's lymphoma: a systematic review. Cancer Treat Rev. 2013 Nov;39(7):812-7. doi: 10.1016/j.ctrv.2013.01.007. Epub 2013 Mar 6. PMID 23473865