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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
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Healthy, no Evidence of Disease Other: IMPACT intervention Other: Online education materials Other: survey administration Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1262 participants
Allocation: Randomized
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

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: Online education materials
Online NCI-based educational materials
Other Name: intervention, educational

Other: survey administration
Ancillary studies




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Number of patients enrolled in clinical trials [ Time Frame: Up to 3 months post-intervention ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

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


Locations
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United States, Ohio
University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Neal Meropol, MD Case Comprehensive Cancer Center
Principal Investigator: Barbara Daly, PhD Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02129517     History of Changes
Other Study ID Numbers: CASE2Z14
NCI-2014-00829 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE2Z14 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: May 2, 2014    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017