Colorectal Cancer (CRC) Surveillance Tool: Cognitive and Pilot Testing

Colorectal Cancer Clinical Trial

Official title:

Colorectal Cancer Surveillance Decision Support Tool: Cognitive and Pilot Testing

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03180411
• Other study ID #: PA16-0825
• Secondary ID: CE-1304-6855NCI-
• Status: Completed
• Start date: February 14, 2017
• Est. completion date: November 30, 2022

Study information

• Verified date: July 2022
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this research study to help develop a tool to assist patients in making decisions about care during treatment for colorectal cancer. Information collected during this study will be saved to help develop future studies about patient decision making in cancer treatment.

Description:

Cognitive Testing Phase:

If participant agrees to take part in this study, participant will take part in a one-on-one interview where participant will be asked questions about participant's health and the disease. This is called the cognitive testing phase. Notes about the interviews may be kept so that the responses can be reviewed later by the study doctor and research staff.The interview may take from 45-60 minutes to complete.

Pilot Testing Phase:

Participant may be asked to take part in the next phase of the study called the pilot testing phase. If participant takes part in this phase, participant will have a second one-on-one interview. The interview will last from 45-60 minutes.

Participant may also be asked to complete a questionnaire about the disease, what participant understands about it, and the treatment plan recommended for participant. Participant will also be asked to give participant's opinion about colorectal cancer follow-up materials. If participant is asked to complete it, the questionnaire will be completed during the interview, in person. The questionnaire will take 35-45 minutes.

Collection of Information:

Information may be collected from participant's medical record about participant's health, participant's treatment, basic information like participant's age and participant's gender, and the disease. Information will not be collected from all participants.

Length of Study Participation:

If participant takes part in the cognitive testing phase only, participation in this study will end when participant has completed the interview.

If participant takes part in the pilot testing phase, participation in this study will end when participant has completed the second interview and questionnaire if participant was asked to complete it.

This is an investigational study.

Up to 100 participants will be enrolled in this study. All will take part at MD Anderson.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 or older

2. Able to read and speak English

3. Patient undergoing follow-up for curative resection of stage I-IV colon or rectal cancer

4. There will be no exclusion on the basis of gender or race.

Exclusion Criteria:

N/A

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Interview
Cognitive Testing Phase Group: Participants take part in one-on-one interview with research staff and asked questions about participant's health and the disease. The interview may take from 45-60 minutes to complete. Pilot Testing Phase Group: After Cognitive Testing Phase interview, participants have a second one-on-one interview. The interview will last from 45-60 minutes.
• Questionnaire
Participant completes a questionnaire about the disease, what participant understands about it, and the treatment plan recommended. Participant asked to give participant's opinion about colorectal cancer follow-up materials. The questionnaire will take 35-45 minutes.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of Decision Tool to Guide Participants in Making Individualized Decisions Regarding Colorectal Cancer (CRC) Surveillance Through the Use of Cognitive Testing Interviews		2 years

External Links

•   MD Anderson Cancer Center