Clinical trial NCT02217865: Patient-Centered Risk Adjusted Surveillance After Curative Resection of Colorectal Cancer
Official title: Patient-Centered Risk Adjusted Surveillance After Curative Resection of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
CRC
Curative resection of colorectal cancer
Caregivers
Interviews
Focus groups
Questionnaires
Surveys
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: Alliance for Clinical Trials in Oncology
First posted: 2014-08-15
Enrollment: 32
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of MD Anderson Colorectal Center and their caregivers recruited by study staff.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Age 21 or older
2. Able to read and speak English
3. Able to undergo a 30 to 60-minute interview or focus group
4. 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
5. For phase 2: Colon or rectal cancer patient

Exclusion Criteria:

N/A

Primary outcomes:
measure: Effectiveness of Colorectal Cancer (CRC) Surveillance
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Houston
country: United States
facility: Lyndon B. Johnson General Hospital
state: Texas
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: George J. Chang, MD,MS
role: STUDY_CHAIR
affiliation: M.D. Anderson Cancer Center
name: Robert Volk, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Snyder 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.