Colorectal CancerNCT03180411
Colorectal Cancer (CRC) Surveillance Tool: Cognitive and Pilot Testing
An observational study of Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Interview and Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2017to 30 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Colorectal surgery clinics at UT MD Anderson Cancer Center in Houston, Texas
Who may be able to join
- 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
- There will be no exclusion on the basis of gender or race.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Colorectal Cancer Surveillance Decision Support Tool: Cognitive and Pilot Testing
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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Interview, Questionnaire
- Keywords
- Colorectal Cancer, CRC, Colorectal cancer surveillance, Decision support tool, Interviews, Questionnaire, Survey
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewBehavioural
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.
QuestionnaireBehavioural
Also called Survey
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Interview; Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Development of Decision Tool to Guide Participants in Making Individualized Decisions Regarding Colorectal Cancer (CRC) Surveillance Through the Use of Cognitive Testing Interviews
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start14 Feb 2017
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- George Chang, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180411
- Sponsor's protocol ID
- PA16-0825
- Other IDs
- CE-1304-6855, NCI-2021-09747
- Status last verified
- Jul 2022
- First submitted
- 2 Jun 2017
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Surveillance Decision Support Tool: Cognitive and Pilot Testing
- ClinicalTrials.gov ID
- NCT03180411
- Acronym / sponsor ID
- PA16-0825
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, CRC, Colorectal cancer surveillance, Decision support tool, Interviews, Questionnaire, Survey
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 14 Feb 2017 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 8 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Testing Phase Group | – | Behavioral: InterviewParticipants take part in one-on-one interview with research staff and asked questions about participant's health and the disease. |
| Pilot Testing Phase Group | – | Behavioral: Interview, Behavioral: QuestionnaireAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Colorectal surgery clinics at UT MD Anderson Cancer Center in Houston, Texas
Key inclusion criteria (4 listed)
- 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
- There will be no exclusion on the basis of gender or race.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewCognitive 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. | Behavioural | Cognitive Testing Phase Group, Pilot Testing Phase Group |
| QuestionnaireAlso: SurveyParticipant 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. | Behavioural | Pilot Testing Phase Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George Chang, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.