Chronic Lymphocytic Leukemia Electronic Patient Reported Outcomes Study

Completed

Conditions studied: CLL

In brief

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.

Key facts

Study ID

NCT03231579

Run by

Carevive Systems, Inc.

People needed

85

Starts

2017-07-21

Expected to finish

2019-03-31

Last updated by the study team

2019-08-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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).
• The inclusion and exclusion criteria above will be used to screen for eligibility of all patients.

Where it is running

• Moffitt Cancer Institute — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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