NCT02129517

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,262

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

November 7, 2014

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

July 21, 2020

Status Verified

July 1, 2020

Enrollment Period

2.9 years

First QC Date

April 30, 2014

Last Update Submit

July 20, 2020

Conditions

Healthy, no Evidence of Disease

Outcome Measures

Primary Outcomes (1)

  • Change in nurse's intention to discuss clinical trials with patients

    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.

    Baseline to 3 months post-intervention

Secondary Outcomes (1)

  • Change in knowledge, attitudes, normative beliefs, and perceived behavioral control

    Baseline to 3 months post-intervention

Other Outcomes (1)

  • Number of patients enrolled in clinical trials

    Up to 3 months post-intervention

Study Arms (2)

Arm I (IMPACT Intervention)

EXPERIMENTAL

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 interventionOther: survey administration

Arm II (online educational materials)

ACTIVE COMPARATOR

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 materialsOther: survey administration

Interventions

IMPACT interventionOTHER

Tailored, web-based educational short video clips

Also known as: intervention, educational, educational intervention
Arm I (IMPACT Intervention)
Online education materialsOTHER

Online NCI-based educational materials

Also known as: intervention, educational
Arm II (online educational materials)
survey administrationOTHER

Ancillary studies

Arm I (IMPACT Intervention)Arm II (online educational materials)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Research nurses, nurses without direct patient care, and nurse managers/directors (i.e. not involved in direct patient care)
  • Lack of email address

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cleveland, Ohio, 44106-5065, United States

Location

Related Publications (1)

  • 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.

    PMID: 30782111DERIVED

MeSH Terms

Interventions

MethodsEarly Intervention, Educational

Intervention Hierarchy (Ancestors)

Investigative TechniquesChild Health ServicesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesPreventive Health Services

Study Officials

  • Neal Meropol, MD

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

  • Barbara Daly, PhD

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 30, 2014

First Posted

May 2, 2014

Study Start

November 7, 2014

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

July 21, 2020

Record last verified: 2020-07

Locations

US(1)