Web-Based Tailored Educational Program in Improving Nurse Communication With Patients About Clinical Trials
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|ClinicalTrials.gov Identifier: NCT02129517|
Recruitment Status : Completed
First Posted : May 2, 2014
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Healthy, no Evidence of Disease||Other: IMPACT intervention Other: Online education materials Other: survey administration||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||1262 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Oncology Nurse IMPACT: Improving Communication With Patients About Clinical Trials|
|Actual Study Start Date :||November 7, 2014|
|Actual Primary Completion Date :||October 1, 2017|
|Actual Study Completion Date :||October 1, 2017|
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: survey administration
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: Online education materials
Online NCI-based educational materials
Other Name: intervention, educational
Other: survey administration
- 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.
- 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.
- Number of patients enrolled in clinical trials [ Time Frame: Up to 3 months post-intervention ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129517
|United States, Ohio|
|University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44106-5065|
|Principal Investigator:||Neal Meropol, MD||Case Comprehensive Cancer Center|
|Principal Investigator:||Barbara Daly, PhD||Case Comprehensive Cancer Center|