NCT03907579

Brief Summary

The purpose of this research is to understand if an educational program about colorectal cancer helps improve people's knowledge of colorectal cancer prevention and screening and their intention to get screened for colorectal cancer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Mar 2017

Shorter than P25 for not_applicable colorectal-cancer

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

Study Start

First participant enrolled

March 11, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 17, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 17, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 9, 2019

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

September 4, 2020

Completed
Last Updated

September 4, 2020

Status Verified

August 1, 2020

Enrollment Period

3 months

First QC Date

April 6, 2019

Results QC Date

July 8, 2020

Last Update Submit

August 19, 2020

Conditions

Keywords

Knowledge

Outcome Measures

Primary Outcomes (2)

  • Change in Knowledge Related to Colorectal Cancer Risk, Prevention, and Screening

    A pre-test and post-test is conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via 14 questions before and after learning).

    Baseline and immediately following intervention

  • Number of Participants With Varying Levels of Behavioral Intentions Related to Colorectal Cancer Screening and Prevention

    Post-test conducted to assess behavioral intention related to five prevention and screening behaviors (assessed via 5 questions on a 4-point Likert scale, where a higher score indicates stronger behavioral intention). The scale for all behavioral intention measures started with, "As a result of the colorectal cancer screening information I received during the Screen to Save educational session, I am more likely to…"

    Immediately following intervention

Study Arms (1)

Inflatable colon educational module

EXPERIMENTAL

Participants attend a brief educational presentation in an inflatable colon, focused on colorectal cancer prevention and screening. Participants also receive a copy of the study information sheet and may receive written educational materials to take home. Participants complete a pre-test and a post-test to assess changes in knowledge and intention to get screened for colorectal cancer.

Behavioral: Inflatable colon educational module

Interventions

Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening.

Inflatable colon educational module

Eligibility Criteria

Age50 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 50-74 years old
  • Attendee at event where educational module is offered

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norris Cotton Cancer Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Results Point of Contact

Title
Director of Community Education and Prevention
Organization
Dartmouth-Hitchcock Norris Cotton Cancer Center

Study Officials

  • Tracy Onega, PhD, MA, MS

    Dartmouth College

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Director of Community Outreach and Education, Norris Cotton Cancer Center; Associate Professor, Dartmouth Geisel School of Medicine

Study Record Dates

First Submitted

April 6, 2019

First Posted

April 9, 2019

Study Start

March 11, 2017

Primary Completion

June 17, 2017

Study Completion

June 17, 2017

Last Updated

September 4, 2020

Results First Posted

September 4, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

All of the individual de-identified data collected during the trial will be shared with the National Cancer Institute, Geographic Management of Cancer Health Disparities Program (GMaP) contacts, and NCI's designated contractor for the Screen to Save Initiative

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Immediately following data collection events
Access Criteria
For meta-analyses

Locations