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Trial record 4 of 406 for:    colorectal | Recruiting Studies | United States

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

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ClinicalTrials.gov Identifier: NCT03180411
Recruitment Status : Recruiting
First Posted : June 8, 2017
Last Update Posted : June 8, 2017
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief 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.

Condition or disease Intervention/treatment
Colorectal Cancer Behavioral: Interview Behavioral: Questionnaire

Detailed 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.


Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Colorectal Cancer Surveillance Decision Support Tool: Cognitive and Pilot Testing
Actual Study Start Date : February 14, 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.
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.

Pilot Testing Phase Group

After Cognitive Testing Phase interview, participants may be asked to have a second one-on-one interview with research staff.

Participants may also be asked to complete a questionnaire about the disease, what participant understands about it, and the treatment plan recommended. Participant also asked to give participant's opinion about colorectal cancer follow-up materials.

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.

Behavioral: 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.
Other Name: Survey



Primary Outcome Measures :
  1. Development of Decision Tool to Guide Participants in Making Individualized Decisions Regarding Colorectal Cancer (CRC) Surveillance Through the Use of Cognitive Testing Interviews [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Colorectal surgery clinics at UT MD Anderson Cancer Center in Houston, Texas
Criteria

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:


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): NCT03180411


Contacts
Contact: George Chang, MD, MS 713-792-6940 CR_Study_Registration@mdanderson.org

Locations
United States, Texas
University of Texas MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinical Research Operations       CR_Study_Registration@mdanderson.org   
Sponsors and Collaborators
M.D. Anderson Cancer Center
Patient-Centered Outcomes Research Institute

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT03180411     History of Changes
Other Study ID Numbers: PA16-0825
CE-1304-6855 ( Other Grant/Funding Number: PCORI )
First Posted: June 8, 2017    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Colorectal Cancer
CRC
Colorectal cancer surveillance
Decision support tool
Interviews
Questionnaire
Survey

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases