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

Healthy, no Evidence of Disease Clinical Trial

Official title:

Oncology Nurse IMPACT: Improving Communication With Patients About Clinical Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02129517
• Other study ID #: CASE2Z14
• Secondary ID: NCI-2014-00829CA
• Status: Completed
• Phase: N/A
• Start date: November 7, 2014
• Est. completion date: October 1, 2017

Study information

• Verified date: July 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1262
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy, no Evidence of Disease

Intervention

Other:
• IMPACT intervention
Tailored, web-based educational short video clips
• Online education materials
Online NCI-based educational materials
• survey administration
Ancillary studies

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients enrolled in clinical trials		Up to 3 months post-intervention
Primary	Change in nurse's intention to discuss clinical trials with patients	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	Change in knowledge, attitudes, normative beliefs, and perceived behavioral control	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