NCT02619604

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

February 15, 2017

Status Verified

January 1, 2017

Enrollment Period

9 months

First QC Date

November 30, 2015

Last Update Submit

February 14, 2017

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in provider knowledge with management of Quality of Life Concerns for CLL patients, as measured by survey

    Baseline, 6 months

  • Change in provider confidence with management of Quality of Life Concerns for CLL patients, as measured by survey

    Baseline, 6 months

Study Arms (1)

Clinician education

OTHER
Other: Education Intervention

Interventions

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.

Clinician education

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • None
  • Patient is Non-English speaking
  • Patient diagnosed with CLL \< 60 days ago

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke Cancer Network

Durham, North Carolina, United States

Location

MeSH Terms

Conditions

Leukemia, Lymphocytic, Chronic, B-Cell

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Leukemia, B-CellLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Child Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Linda Sutton, MD

    Duke University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 2, 2015

Study Start

May 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 1, 2017

Last Updated

February 15, 2017

Record last verified: 2017-01

Locations