Web-Based Tailored Educational Program in Improving Nurse Communication With Patients About Clinical Trials

NCT ID: NCT02129517

Last Updated: 2020-07-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1262 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-07

Study Completion Date

2017-10-01

Brief Summary

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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

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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.

Conditions

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Healthy, no Evidence of Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

IMPACT intervention

Intervention Type OTHER

Tailored, web-based educational short video clips

survey administration

Intervention Type OTHER

Ancillary studies

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.

Group Type ACTIVE_COMPARATOR

Online education materials

Intervention Type OTHER

Online NCI-based educational materials

survey administration

Intervention Type OTHER

Ancillary studies

Interventions

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IMPACT intervention

Tailored, web-based educational short video clips

Intervention Type OTHER

Online education materials

Online NCI-based educational materials

Intervention Type OTHER

survey administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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intervention, educational educational intervention intervention, educational

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Neal Meropol, MD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Barbara Daly, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Locations

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

Cleveland, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30782111 (View on PubMed)

Other Identifiers

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NCI-2014-00829

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE2Z14

Identifier Type: OTHER

Identifier Source: secondary_id

CASE2Z14

Identifier Type: -

Identifier Source: org_study_id

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