Colorectal CancerNCT02217865
Patient-Centered Risk Adjusted Surveillance After Curative Resection of Colorectal Cancer
An observational study of Colorectal Cancer, run by M.D. Anderson Cancer Center at 3 sites in United States.
Trial summary
The long-term goal of this research is to develop new tools to guide patients, caregivers, and clinicians in making individualized decisions regarding colorectal cancer (CRC) surveillance. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Interviews - Colorectal Cancer Participants, Questionnaire and Focus Groups
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 16 Jul 2014to 13 Jan 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients of MD Anderson Colorectal Center and their caregivers recruited by study staff.
Who may be able to join
- Age 21 or older
- Able to read and speak English
- Able to undergo a 30 to 60-minute interview or focus group
- For phase 1: MD Anderson patient undergoing follow-up for curative resection of stage I-IV colon or rectal cancer OR caregiver of such a patient
- For phase 2: Colon or rectal cancer patient
Who cannot join
- N/A
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Lyndon B. Johnson General Hospital
Houston, Texas, 77026
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
University of California San Francisco
San Francisco, California, 94143
About this study
The long-term goal of this research is to develop new tools to guide patients, caregivers, and clinicians in making individualized decisions regarding colorectal cancer (CRC) surveillance. As part of a Patient-Centered Outcomes Research Institute-funded contract, investigator will analyze surveillance data to determine the effectiveness of CRC surveillance and recurrence risk taking into account different patient and tumor characteristics; identify key issues about CRC surveillance important to patients, caregivers, and clinicians; and integrate the recurrence risk and patient priorities into a patient-centered, risk stratified surveillance strategy by creating an interactive decision aid for use by patients and clinicians.
This protocol addresses a formative step in the creation of the interactive decision aid where patients' information needs and preferences are assessed regarding decisions about surveillance.
Read more
The specific aims of this protocol are:
Phase 1 - To interview patients and their caregivers to determine their concerns, preferences and key priorities regarding surveillance after curative resection of colorectal cancer, and
Phase 2 - To refine the key priorities identified in phase 1 through focus groups and surveys with patients and caregivers.
Read the detailed description
You are being asked to take part in this research study which is conducted at The University of Texas MD Anderson ("MD Anderson") and the Harris Health System because you (or someone you act as a caregiver for) are undergoing follow-up after curative resection of colorectal cancer.
The goal of this study is to find out the key priorities for patients and their caregivers when it comes to surveillance after curative resection of colorectal cancer. Your responses will help develop decision aids to help future colorectal cancer patients make more informed decisions about surveillance.
If you agree to participate in this study, you will take part in an interview or focus group in person at MD Anderson, the Harris Health System, or the Alliance. The interview or focus group is expected to take between 30 minutes and 1 hour. The interview or focus group will be audiorecorded. Your name or other identifying information will not appear in the transcript. Adept Word Management, a transcription service that has been approved by the institution, may transcribe the interviews.
You will be asked questions about:
- your priorities and concerns about colorectal cancer surveillance
- what you know about colorectal cancer and surveillance,
- your cancer and treatment (or the patients'),
- the impact or inconvenience that surveillance causes,
- who you think should make decisions about surveillance,
- your thoughts about different surveillance scenarios,
- and general questions about your age, race, sex, education, and income level.
Information about you will be collected from the medical records and existing data in a database of colorectal patients that is used to organize existing information about colorectal patients to better understand the disease. Information collected will include things like age, gender, marital status, information about the tumor, type of surgery, and what treatment was done before and after surgery. There are no other plans to share your information with others outside the study.
Your participation will be over when the interview is complete. If you are undergoing follow-up for colorectal cancer, research staff will look at your medical record after the interview for information about your cancer including tumor characteristics.
Your participation is completely voluntary. Whether you say yes or no will not change your medical care.
Up to 220 patients and their caregivers will participate in this multicenter study. Up to 190 patients and their caregivers will be enrolled at MD Anderson. Up to 10 patients and their caregivers will be enrolled at the Harris Health System.
- Conditions
- Colorectal Cancer
- Being tested
- Interviews - Colorectal Cancer Participants, Questionnaire, Focus Groups, Interviews - Caregivers of Colorectal Cancer Participants
- Keywords
- Colorectal Cancer, CRC, Curative resection of colorectal cancer, Caregivers, Interviews, Focus groups, Questionnaires, Surveys
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews - Colorectal Cancer ParticipantsBehavioural
Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.
QuestionnaireBehavioural
Also called Survey
Questionnaire completion asking general health and demographic questions.
Focus GroupsBehavioural
Focus groups conducted with participants and caregivers. Up to 4 focus groups conducted with up to 30 participants each. Focus groups expected to take 30 to 60 minutes.
Interviews - Caregivers of Colorectal Cancer ParticipantsBehavioural
Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.
| Study group | Role | What they receive |
|---|---|---|
| Colorectal Cancer Participants | Colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer. Receives: Behavioral: Interviews - Colorectal Cancer Participants; Behavioral: Questionnaire; Behavioral: Focus Groups | |
| Caregivers of Colorectal Cancer Participants | Caregivers of colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer. Receives: Behavioral: Interviews - Colorectal Cancer Participants; Behavioral: Focus Groups; Behavioral: Interviews - Caregivers of Colorectal Cancer Participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of Colorectal Cancer (CRC) Surveillance
Semi-structured interviews and focus groups reviewed to identify themes related to participants' and caregiver's priorities regarding surveillance of colorectal cancer.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study start16 Jul 2014
- Primary completion13 Jan 2022
- Study completion13 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Alliance for Clinical Trials in Oncology
- Responsible party
- Sponsor
- Investigators
- George J. Chang, MD,MS, Study chair, M.D. Anderson Cancer CenterRobert Volk, PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217865
- Sponsor's protocol ID
- PA13-1002
- Other IDs
- CE13-04-6855
- Status last verified
- Feb 2022
- First submitted
- 13 Aug 2014
- Last updated
- 15 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Publications
Zafar SN, Hu CY, Snyder RA, Cuddy A, You YN, Lowenstein LM, Volk RJ, Chang GJ. Predicting Risk of Recurrence After Colorectal Cancer Surgery in the United States: An Analysis of a Special Commission on Cancer National Study. Ann Surg Oncol. 2020 Aug;27(8):2740-2749. doi: 10.1245/s10434-020-08238-7. Epub 2020 Feb 20.
PubMed 32080809Snyder RA, Hu CY, Cuddy A, Francescatti AB, Schumacher JR, Van Loon K, You YN, Kozower BD, Greenberg CC, Schrag D, Venook A, McKellar D, Winchester DP, Chang GJ; Alliance for Clinical Trials in Oncology Network Cancer Surveillance Optimization Working Group. Association Between Intensity of Posttreatment Surveillance Testing and Detection of Recurrence in Patients With Colorectal Cancer. JAMA. 2018 May 22;319(20):2104-2115. doi: 10.1001/jama.2018.5816.
PubMed 29800181
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Risk Adjusted Surveillance After Curative Resection of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT02217865
- Acronym / sponsor ID
- PA13-1002
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal Cancer, CRC, Curative resection of colorectal cancer, Caregivers, Interviews, Focus groups, Questionnaires, Surveys
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute, Alliance for Clinical Trials in Oncology
- Study start
- 16 Jul 2014 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 15 Aug 2014 (estimated)
- 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 long-term goal of this research is to develop new tools to guide patients, caregivers, and clinicians in making individualized decisions regarding colorectal cancer (CRC) surveillance. As part of a Patient-Centered Outcomes Research Institute-funded contract, investigator will analyze surveillance data to determine the effectiveness of CRC surveillance and recurrence risk taking into account different patient and tumor characteristics; identify key issues about CRC surveillance important to patients, caregivers, and clinicians; and integrate the recurrence risk and patient priorities into a patient-centered, risk stratified surveillance strategy by creating an interactive decision aid for use by patients and clinicians.
This protocol addresses a formative step in the creation of the interactive decision aid where patients' information needs and preferences are assessed regarding decisions about surveillance.
The specific aims of this protocol are:
Phase 1 - To interview patients and their caregivers to determine their concerns, preferences and key priorities regarding surveillance after curative resection of colorectal cancer, and
Phase 2 - To refine the key priorities identified in phase 1 through focus groups and surveys with patients and caregivers.
Detailed description
You are being asked to take part in this research study which is conducted at The University of Texas MD Anderson ("MD Anderson") and the Harris Health System because you (or someone you act as a caregiver for) are undergoing follow-up after curative resection of colorectal cancer.
The goal of this study is to find out the key priorities for patients and their caregivers when it comes to surveillance after curative resection of colorectal cancer. Your responses will help develop decision aids to help future colorectal cancer patients make more informed decisions about surveillance.
If you agree to participate in this study, you will take part in an interview or focus group in person at MD Anderson, the Harris Health System, or the Alliance. The interview or focus group is expected to take between 30 minutes and 1 hour. The interview or focus group will be audiorecorded. Your name or other identifying information will not appear in the transcript. Adept Word Management, a transcription service that has been approved by the institution, may transcribe the interviews.
You will be asked questions about:
- your priorities and concerns about colorectal cancer surveillance
- what you know about colorectal cancer and surveillance,
- your cancer and treatment (or the patients'),
- the impact or inconvenience that surveillance causes,
- who you think should make decisions about surveillance,
- your thoughts about different surveillance scenarios,
- and general questions about your age, race, sex, education, and income level.
Information about you will be collected from the medical records and existing data in a database of colorectal patients that is used to organize existing information about colorectal patients to better understand the disease. Information collected will include things like age, gender, marital status, information about the tumor, type of surgery, and what treatment was done before and after surgery. There are no other plans to share your information with others outside the study.
Your participation will be over when the interview is complete. If you are undergoing follow-up for colorectal cancer, research staff will look at your medical record after the interview for information about your cancer including tumor characteristics.
Your participation is completely voluntary. Whether you say yes or no will not change your medical care.
Up to 220 patients and their caregivers will participate in this multicenter study. Up to 190 patients and their caregivers will be enrolled at MD Anderson. Up to 10 patients and their caregivers will be enrolled at the Harris Health System.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer Participants | – | Behavioral: Interviews - Colorectal Cancer Participants, Behavioral: Questionnaire, Behavioral: Focus GroupsColorectal cancer participants undergoing follow-up after curative resection of colorectal cancer. |
| Caregivers of Colorectal Cancer Participants | – | Behavioral: Interviews - Colorectal Cancer Participants, Behavioral: Focus Groups, Behavioral: Interviews - Caregivers of Colorectal Cancer ParticipantsCaregivers of colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of MD Anderson Colorectal Center and their caregivers recruited by study staff.
Key inclusion criteria (5 listed)
- Age 21 or older
- Able to read and speak English
- Able to undergo a 30 to 60-minute interview or focus group
- For phase 1: MD Anderson patient undergoing follow-up for curative resection of stage I-IV colon or rectal cancer OR caregiver of such a patient
- For phase 2: Colon or rectal cancer patient
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 |
|---|---|---|
| Interviews - Colorectal Cancer ParticipantsSemi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour. | Behavioural | Caregivers of Colorectal Cancer Participants, Colorectal Cancer Participants |
| QuestionnaireAlso: SurveyQuestionnaire completion asking general health and demographic questions. | Behavioural | Colorectal Cancer Participants |
| Focus GroupsFocus groups conducted with participants and caregivers. Up to 4 focus groups conducted with up to 30 participants each. Focus groups expected to take 30 to 60 minutes. | Behavioural | Caregivers of Colorectal Cancer Participants, Colorectal Cancer Participants |
| Interviews - Caregivers of Colorectal Cancer ParticipantsSemi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour. | Behavioural | Caregivers of Colorectal Cancer Participants |
Primary outcome
Effectiveness of Colorectal Cancer (CRC) Surveillance
Time frame: 1 day
Semi-structured interviews and focus groups reviewed to identify themes related to participants' and caregiver's priorities regarding surveillance of colorectal cancer.
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 15 Feb 2022.
- Derived from this study: PubMed 32080809Zafar SN, Hu CY, Snyder RA, Cuddy A, You YN, Lowenstein LM, Volk RJ, Chang GJ. Predicting Risk of Recurrence After Colorectal Cancer Surgery in the United States: An Analysis of a Special Commission on Cancer National Study. Ann Surg Oncol. 2020 Aug;27(8):2740-2749. doi: 10.1245/s10434-020-08238-7. Epub 2020 Feb 20.
- Derived from this study: PubMed 29800181Snyder RA, Hu CY, Cuddy A, Francescatti AB, Schumacher JR, Van Loon K, You YN, Kozower BD, Greenberg CC, Schrag D, Venook A, McKellar D, Winchester DP, Chang GJ; Alliance for Clinical Trials in Oncology Network Cancer Surveillance Optimization Working Group. Association Between Intensity of Posttreatment Surveillance Testing and Detection of Recurrence in Patients With Colorectal Cancer. JAMA. 2018 May 22;319(20):2104-2115. doi: 10.1001/jama.2018.5816.
- University of Texas MD Anderson Cancer Center WebsiteLink 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 J. Chang, MD,MS study chair
M.D. Anderson Cancer Center
Robert Volk, PHD principal investigator
M.D. Anderson Cancer Center
3 sites 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 3 sites 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 5 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 15 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Effectiveness of Colorectal Cancer (CRC) Surveillance (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02217865, which also lists 2 linked publications.
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 15 Feb 2022.