Clinical trial NCT02129517: Web-Based Tailored Educational Program in Improving Nurse Communication With Patients About Clinical Trials
Official title: Oncology Nurse IMPACT: Improving Communication With Patients About Clinical Trials
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy, no Evidence of Disease
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-05-02
Enrollment: 1262
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in nurse's intention to discuss clinical trials with patients
timeFrame: Baseline to 3 months post-intervention
Secondary outcomes:
measure: Change in knowledge, attitudes, normative beliefs, and perceived behavioral control
timeFrame: Baseline to 3 months post-intervention
Other outcomes:
measure: Number of patients enrolled in clinical trials
timeFrame: Up to 3 months post-intervention
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Neal Meropol, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Comprehensive Cancer Center
name: Barbara Daly, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flocke SA, Nock NL, Fulton S, Margevicius S, Manne S, Meropol NJ, Daly BJ. A National Study of Oncology Nurses Discussing Cancer Clinical Trials With Patients. West J Nurs Res. 2019 Dec;41(12):1747-1760. doi: 10.1177/0193945919829145. Epub 2019 Feb 19.