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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02129517
Other study ID # CASE2Z14
Secondary ID NCI-2014-00829CA
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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