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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02619604
Other study ID # Pro00063975
Secondary ID
Status Completed
Phase N/A
First received November 30, 2015
Last updated February 14, 2017
Start date May 2016
Est. completion date February 2017

Study information

Verified date January 2017
Source Duke University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This project addresses the need to improve physician knowledge and clinical practice patterns related to quality of life (QoL) concerns for patients with chronic lymphocytic leukemia (CLL).


Description:

This multifaceted initiative will include evaluating patient perspectives on their QoL, evaluating provider perspectives on managing QoL, and providing education to the whole CLL care team (hematologists/oncologists, nurse practitioners, physician assistants, and nurses) on contemporary approaches for individualized, patient-centered management of CLL. Providers, including physicians, nurse practitioners, and physician assistants will participate in educational initiatives geared towards enhancing their knowledge and confidence with managing QoL concerns for patients with CLL. Pre and post surveys will be conducted with providers to evaluate change in these areas. The project aims to train this team on how to enhance communication with patients and caregivers as a means to increase patient engagement in care and QoL in this population.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date February 2017
Est. primary completion date February 2017
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: Clinician

- Participant must be a hematologist, oncologist, nurse practitioner, or physician assistant who practices medicine in the Duke Cancer Network

- Participant treats patients with CLL

- Participant is willing to participate in the educational component of this project

Inclusion Criteria: Patient

- Patient has a diagnosis of Chronic Lymphocytic Leukemia

- Patient is over the age of 18

- Patient is being treated at a Duke Cancer Network affiliate site,

- Patient is expected to see their physician or another member of their care team at least 3 times annually.

- Signed informed consent

Exclusion Criteria: Clinician

Exclusion Criteria: Patient

- Patient is Non-English speaking

- Patient diagnosed with CLL < 60 days ago

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Education Intervention
Education interventions will be delivered sporadically within the 6-month window between the time the clinician completes the pre-survey and when he/she completes the post-survey. Interventions consist of e-brief publications, teleconferences with project faculty, and evidence based resources.

Locations

Country Name City State
United States Duke Cancer Network Durham North Carolina

Sponsors (4)

Lead Sponsor Collaborator
Duke University Genentech, Inc., Gilead Sciences, Med-IQ

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in provider knowledge with management of Quality of Life Concerns for CLL patients, as measured by survey Baseline, 6 months
Primary Change in provider confidence with management of Quality of Life Concerns for CLL patients, as measured by survey Baseline, 6 months
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