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Patient navigation and clinical trial participation: A randomized controlled trial design.


ABSTRACT:

Background

To our knowledge, no published studies utilizing a randomized controlled design have examined the efficacy of patient navigation for improving clinical trial enrollment.

Methods

This patient navigation and clinical trial participation study is a randomized controlled trial to assess the effect of a patient navigator on enrollment into therapeutic cancer clinical trials. Participants are randomly assigned to high intensity, patient navigator-delivered patient educational materials (PEM) and needs assessment vs. low intensity patient navigation (patient navigator-delivered patient educational materials [PEM] alone). Discussion: Effective enrollment strategies may include utilization of patient navigators as away to meet individual needs, barriers, and concerns of participants enrolled in clinical trials.

SUBMITTER: Uveges MK 

PROVIDER: S-EPMC6197623 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Publications

Patient navigation and clinical trial participation: A randomized controlled trial design.

Uveges Melissa Kurtz MK   Lansey Dina George DG   Mbah Olive O   Gray Tamryn T   Sherden Lisa L   Wenzel Jennifer J  

Contemporary clinical trials communications 20180922


<h4>Background</h4>To our knowledge, no published studies utilizing a randomized controlled design have examined the efficacy of patient navigation for improving clinical trial enrollment.<h4>Methods</h4>This patient navigation and clinical trial participation study is a randomized controlled trial to assess the effect of a patient navigator on enrollment into therapeutic cancer clinical trials. Participants are randomly assigned to high intensity, patient navigator-delivered patient educational  ...[more]

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