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Colorectal Health Research Champions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04812743
Recruitment Status : Recruiting
First Posted : March 24, 2021
Last Update Posted : March 30, 2021
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
The purpose of the Colorectal Health Research Champions program is to provide accurate and reliable colorectal health cancer information that they can share within their communities to encourage cancer prevention, screening, and early detection, as well as the importance of participating in research.

Condition or disease Intervention/treatment Phase
Cancer of Colon Cancer of Rectum Behavioral: Colorectal Health Research Champions Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Colorectal Health Research Champions
Actual Study Start Date : January 10, 2020
Estimated Primary Completion Date : April 30, 2023
Estimated Study Completion Date : April 30, 2023

Arm Intervention/treatment
Experimental: Colorectal Health Research Champion trainees
Colorectal Health Research Champion (CHRC) trainees receive 5 education sessions on colorectal cancer, clinical research, biospecimen donation, ethics, and presentation skills. The CHRCs will invite others in their social networks to present to them this educational information, following the train the trainer model of health education.
Behavioral: Colorectal Health Research Champions

20 Colorectal Health Research Champions will be recruited from Danville, Emporia, Lawrenceville, Richmond, and Petersburg.

The Colorectal Health Research Champions will receive training in four specific areas during group educational sessions.

Colorectal Health Research Champions will be asked to disseminate the four defined messages on at least two occasions to small groups in their social network in a venue of their choice (house chats, faith-based, social gatherings, family gatherings, etc.). We ask that each CHRC participant host 2 chats with 5-10 people in attendance at each chat. We expect that at least 200 participants will be invited to chats through 10 CHRCs.





Primary Outcome Measures :
  1. Increase in participants knowledge and intentions related to colorectal cancer screening. [ Time Frame: 4 months ]
    Participant knowledge will be measured using pre/post questionnaires, with each correct answer being worth one point (14 total points) Higher summary scores indicate a greater change in knowledge. Intentions are measured on a 5 -point likert scale.

  2. Increase in knowledge and intentions related to biospecimen donation and clinical trial participation. [ Time Frame: 4 months ]
    Participant knowledge and intentions related to biospecimen donation and clinical trial participation will be measured using pre/post questionnaires, with each correct answer being worth one point (20 total points). Higher summary scores indicate a greater change in knowledge. Intentions are measured on a 5 -point likert scale.



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

the individual is > 30 years of age

  • They are literate
  • They are/were directly or indirectly impacted by colorectal cancer and interested in becoming a champion for colorectal cancer research.

To participate in a chat hosted by the CHRC the inclusion criteria is:

  • adult of any gender
  • over 30 years of age.

Exclusion Criteria for chat hosted by the CHRC:

-Those < 30 years of age


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04812743


Contacts
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Contact: Katelyn Schifano, MS 804-827-0000 schifanokr@vcu.edu

Locations
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United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact: Katelyn Schifano, MS    804-827-0000    schifanokr@vcu.edu   
Principal Investigator: Vanessa Sheppard, PhD         
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Vanessa B Sheppard, PhD Virginia Commonwealth University
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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT04812743    
Other Study ID Numbers: MCC-19-15899
HM20017398 ( Other Identifier: Virginia Commonwealth University IRB )
NCI-2019-08595 ( Other Identifier: NCI )
First Posted: March 24, 2021    Key Record Dates
Last Update Posted: March 30, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Virginia Commonwealth University:
Prevention
Additional relevant MeSH terms:
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Colonic Neoplasms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases