NCT03180411

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2017

Longer than P75 for all trials

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

February 14, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2017

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

December 14, 2022

Status Verified

July 1, 2022

Enrollment Period

5.8 years

First QC Date

June 2, 2017

Last Update Submit

December 12, 2022

Conditions

Keywords

Colorectal CancerCRCColorectal cancer surveillanceDecision support toolInterviewsQuestionnaireSurvey

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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

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: InterviewBehavioral: Questionnaire

Interventions

InterviewBEHAVIORAL

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.

Cognitive Testing Phase GroupPilot Testing Phase Group
QuestionnaireBEHAVIORAL

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.

Also known as: Survey
Pilot Testing Phase Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Colorectal surgery clinics at UT MD Anderson Cancer Center in Houston, Texas

You may qualify if:

  • Age 18 or older
  • Able to read and speak English
  • Patient undergoing follow-up for curative resection of stage I-IV colon or rectal cancer

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Interviews as TopicSurveys and Questionnaires

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • George Chang, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2017

First Posted

June 8, 2017

Study Start

February 14, 2017

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

December 14, 2022

Record last verified: 2022-07

Locations