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Impact of Protect Your Colon™ on CRC Screening

Primary Purpose

Colorectal Cancer Screening

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Protect Your Colon™
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer Screening focused on measuring Decision aid, Stool test, Colonoscopy, CT scan

Eligibility Criteria

45 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Individuals 45 to 75 years old No prior CRC screening Not at high risk for CRC (e.g., inflammatory bowel disease, colon polyposis syndromes, family history of CRC) Exclusion Criteria: Does not speak English Does not have internet access Any records flagged "break the glass" or "research opt out."

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Protect Your Colon™ (Intervention)

Usual Care (Control)

Arm Description

Patients randomized to Protect Your Colon™ will be directed to go through the website at least 2 days before their clinic appointment. Those who finish the decision aid will then review their personalized report which details their priorities in selecting a screening test as well as the test that best matches their values. Patients will also be encouraged to bring their personalized report with them to the visit to discuss with their doctor. All intervention participants will also receive a reminder via email one day before their scheduled clinic visit. They will be reminded to go through the Protect Your Colon™ website before the clinic visit and to bring their personalized report with them to the visit.

The usual care group will be managed according to the providers' customary practices: CRC screening discussions, if any, are at the discretion of the provider as Cedars-Sinai does not employ a standardized approach. Patients randomized to the control arm will not be sent any materials before their clinic appointment.

Outcomes

Primary Outcome Measures

Rate of completion of a CRC screening test
Uptake of CRC screening within 6 months of patients' initial visit

Secondary Outcome Measures

Qualitative feedback on details of CRC screening test
Completion of questionnaire that looks at: Whether CRC screening discussions took place during the visit What specific CRC screening tests were discussed during the visit Patient's intent to complete CRC screening Patient's perceptions on feeling informed about the alternatives, benefits, and risks of the different screening options as well as their clarity on their personal values Patient's assessment of shared decision making on CRC screening Intervention patients' assessment of the usefulness of Protect Your Colon™

Full Information

First Posted
May 18, 2023
Last Updated
July 11, 2023
Sponsor
Cedars-Sinai Medical Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05929820
Brief Title
Impact of Protect Your Colon™ on CRC Screening
Official Title
Pilot Randomized Controlled Trial Assessing the Impact of Protect Your Colon™ on Colorectal Cancer Screening Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the research is to assess the impact of Protect Your Colon™, a colorectal cancer (CRC) screening decision aid, on patients' CRC screening behaviors. The Investigators hypothesize that Protect Your Colon™, through optimizing shared decision making, will lead to selection of a test that accurately matches patients' values and increase CRC screening uptake. To test this hypothesis, the investigators will conduct a pilot randomized controlled trial (RCT) to assess if provision of Protect Your Colon™ improves communication on CRC screening, intent to complete screening, and ultimately uptake of screening vs. usual care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer Screening
Keywords
Decision aid, Stool test, Colonoscopy, CT scan

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
184 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Protect Your Colon™ (Intervention)
Arm Type
Experimental
Arm Description
Patients randomized to Protect Your Colon™ will be directed to go through the website at least 2 days before their clinic appointment. Those who finish the decision aid will then review their personalized report which details their priorities in selecting a screening test as well as the test that best matches their values. Patients will also be encouraged to bring their personalized report with them to the visit to discuss with their doctor. All intervention participants will also receive a reminder via email one day before their scheduled clinic visit. They will be reminded to go through the Protect Your Colon™ website before the clinic visit and to bring their personalized report with them to the visit.
Arm Title
Usual Care (Control)
Arm Type
No Intervention
Arm Description
The usual care group will be managed according to the providers' customary practices: CRC screening discussions, if any, are at the discretion of the provider as Cedars-Sinai does not employ a standardized approach. Patients randomized to the control arm will not be sent any materials before their clinic appointment.
Intervention Type
Behavioral
Intervention Name(s)
Protect Your Colon™
Intervention Description
Protect Your Colon™ is an online decision aid focused on CRC screening. The site will first educate patients on the importance of CRC screening and offer information on the advantages and disadvantages of the available test options. Protect Your Colon™ will then present an interactive conjoint analysis-a quantitative survey technique that elucidates how individuals make complex decisions-to precisely determine individuals' latent preferences regarding CRC screening options. Afterwards, the app will generate a personalized report that rank orders the importance of each test attribute (e.g., accuracy, invasiveness, test frequency) in patients' decision making and identifies the screening modality that best matches their preferences. The report will also be shareable with physicians, enabling patients and providers to engage in shared decision making surrounding CRC screening in the clinic.
Primary Outcome Measure Information:
Title
Rate of completion of a CRC screening test
Description
Uptake of CRC screening within 6 months of patients' initial visit
Time Frame
6 months post visit
Secondary Outcome Measure Information:
Title
Qualitative feedback on details of CRC screening test
Description
Completion of questionnaire that looks at: Whether CRC screening discussions took place during the visit What specific CRC screening tests were discussed during the visit Patient's intent to complete CRC screening Patient's perceptions on feeling informed about the alternatives, benefits, and risks of the different screening options as well as their clarity on their personal values Patient's assessment of shared decision making on CRC screening Intervention patients' assessment of the usefulness of Protect Your Colon™
Time Frame
1 day post visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Individuals 45 to 75 years old No prior CRC screening Not at high risk for CRC (e.g., inflammatory bowel disease, colon polyposis syndromes, family history of CRC) Exclusion Criteria: Does not speak English Does not have internet access Any records flagged "break the glass" or "research opt out."
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christopher V Almario, MD, MSHPM
Phone
310.423.4462
Email
Christopher.Almario@csmc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Antwon Chaplin, BA
Phone
310.248.6790
Email
Antwon.Chaplin@cshs.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher V Almario, MD, MSHPM
Organizational Affiliation
Cedars-Sinai Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antwon Chaplin, BA
Phone
310-248-6790
Email
Antwon.Chaplin@cshs.org
First Name & Middle Initial & Last Name & Degree
Christopher V Almario, MD, MSHPM

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data that support the findings of this study will be available from the principal investigator (Christopher V. Almario) upon reasonable request.
IPD Sharing Time Frame
Data will become available after study completion and for up to 3 years after study completion.
IPD Sharing Access Criteria
The data that support the findings of this study will be available from the principal investigator (Christopher V. Almario) upon reasonable request.

Learn more about this trial

Impact of Protect Your Colon™ on CRC Screening

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