Chronic Lymphocytic Leukemia Electronic Patient Reported Outcomes Study

NCT03231579 | Completed

• 1 other identifier: G411
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

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

CLL

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Year 1

• Longitudinal symptom experience of patients with CLL

  Data collected on the Carevive CPS using the PRO-CTCAE and ESASr tools will be analyzed in order to describe the longitudinal symptom experience

  Year 1

Secondary Outcomes (2)

• ER utilization and hospitalization in elderly patients with CLL

  Year 1

• Patterns of change in provider decision making over time for patients with CLL

  Year 1

Interventions

Carevive CPS BEHAVIORAL

This intervention will focus on the use of the Carevive CPS, enabling providers to deliver evidence-based and personalized treatment care plans to their CLL patients on/starting treatment. The Carevive CPS collects electronic patient reported outcomes (ePROs) and clinical data, reported and generated by clinical staff and/or peer-reviewed evidence, and includes patient education, resources, and referrals developed by cancer clinicians and researchers.

Eligibility Criteria

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

Study Population

Patients with a diagnosis of CLL

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Carevive Systems, Inc.: lead

Study Sites (1)

Moffitt Cancer Institute

Tampa, Florida, 33612, United States

Location

Related Publications (5)

• Brown 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 BACKGROUND

• Cramer 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 BACKGROUND

• Kolodziej 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 BACKGROUND

• Tucci 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 BACKGROUND

• Bellera 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 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2017
• First Posted: July 27, 2017
• Study Start: July 21, 2017
• Primary Completion: November 1, 2018
• Study Completion: March 31, 2019
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)