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Completed

NCT Number: NCT02129517

Web-Based Tailored Educational Program in Improving Nurse 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.

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Key information

Conditions

Healthy, no Evidence of Disease

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IMPACT intervention

Other

Tailored, web-based educational short video clips

Other names: intervention, educational, educational intervention

Online education materials

Other

Online NCI-based educational materials

Other names: intervention, educational

Survey Administration

Other

Ancillary studies

Primary outcomes

  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 outcomes

  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 outcomes

  1. Number of patients enrolled in clinical trials

    Time frame: Up to 3 months post-intervention

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Oncology Nurse IMPACT: Improving Communication With Patients About Clinical Trials

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
May 2, 2014
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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