Web-Based Tailored Educational Program in Improving Nurse Communication With Patients About Clinical Trials

July 20, 2020 updated by: Case Comprehensive Cancer Center

Oncology Nurse IMPACT: Improving Communication With Patients About Clinical Trials

This pilot, randomized clinical trial studies a web-based tailored educational program in improving nurse communication with patients about clinical trial treatment options. A web-based tailored educational program may empower and prepare nurses to discuss clinical trial treatment options with patients and may also increase patient participation in clinical trials.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To develop and pilot test a theory-driven, web-based, tailored, interactive educational program (Oncology Nurse IMPACT: Improving Communication with Patients about Clinical Trials) for oncology nurses to address barriers to discussing clinical trials with patients.

II. To implement Oncology Nurse IMPACT on a national level and conduct a formal program evaluation.

III. To evaluate the mediators and moderators of education program effect on intentions to discuss clinical trials with patients.

OUTLINE: Participants are assigned to 1 of 2 intervention arms.

ARM I: Oncology nurses watch web-based informational video clips addressing knowledge, attitudes, subjective norms, and perceived behavioral control (barriers of discussing clinical trials with patients). They also watch role-play video clips to help improve perceived behavioral control and address attitudinal barriers.

ARM II: Oncology nurses view online clinical trials educational materials developed based upon National Cancer Institute (NCI) clinical trials educational materials for health care providers. The educational materials contain text and tables as presented on the NCI Website.

After completion of study intervention, participants are followed for 3 months.

Study Type

Interventional

Enrollment (Actual)

1262

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106-5065
        • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Currently practicing nurse
  • Involved in direct patient care
  • Self-identify in one of the following primary practice roles--case managers, clinical nurse specialists, nurse practitioners, managers/coordinators, nurse navigators, patient educators, and staff nurses
  • Available email address

Exclusion Criteria:

  • Research nurses, nurses without direct patient care, and nurse managers/directors (i.e. not involved in direct patient care)
  • Lack of email address

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (IMPACT Intervention)
Oncology nurses watch tailored, web-based informational video clips addressing knowledge, attitudes, subjective norms, and perceived behavioral control (barriers of discussing clinical trials with patients). They also watch role-play video clips to help improve perceived behavioral control and address attitudinal barriers.
Other: IMPACT intervention
Tailored, web-based educational short video clips
Other Names:
  • intervention, educational
  • educational intervention
Other: survey administration
Ancillary studies
Active Comparator: Arm II (online educational materials)
Oncology nurses view online clinical trials educational materials developed based upon NCI clinical trials educational materials for health care providers. The educational materials contain text and tables as presented on the NCI Website.
Other: survey administration
Ancillary studies
Other: Online education materials
Online NCI-based educational materials
Other Names:
  • intervention, educational

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in nurse's intention to discuss clinical trials with patients
Time Frame: Baseline to 3 months post-intervention
Behavioral intention will be assessed using 4 items (3 with 7 point scales, strongly agree/strongly disagree and 1 which asks for an estimated number of patients). An analysis of covariance (ANCOVA) will be used to compare intention scores, adjusting for the pre-intervention intention score as well as age, ethnicity, education, access to clinical trials, and years spent in nursing as well as other key factors found to be significantly imbalanced between groups.
Baseline to 3 months post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in knowledge, attitudes, normative beliefs, and perceived behavioral control
Time Frame: Baseline to 3 months post-intervention
Actual behavior will be measured using a 3-item scale asking participants to provide an estimate of how many patients they spoke with about cancer clinical trials in the past three months (3-month follow-up) and over the past week (subset of nurses completing the biweekly ecological momentary assessment surveys). An ANCOVA approach will be used to examine effects of the intervention on knowledge, attitudes, behavioral control and normative beliefs.
Baseline to 3 months post-intervention

Other Outcome Measures

Outcome Measure
Time Frame
Number of patients enrolled in clinical trials
Time Frame: Up to 3 months post-intervention
Up to 3 months post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Comprehensive Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Neal Meropol, MD, Case Comprehensive Cancer Center
  • Principal Investigator: Barbara Daly, PhD, Case Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2014

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

April 30, 2014

First Submitted That Met QC Criteria

April 30, 2014

First Posted (Estimate)

May 2, 2014

Study Record Updates

Last Update Posted (Actual)

July 21, 2020

Last Update Submitted That Met QC Criteria

July 20, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • CASE2Z14 (Other Identifier: Case Comprehensive Cancer Center)
  • NCI-2014-00829 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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