Patient-Centered Risk Adjusted Surveillance After Curative Resection of Colorectal Cancer

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Interviews - Colorectal Cancer Participants; Behavioral: Questionnaire; Behavioral: Focus Groups; Behavioral: Interviews - Caregivers of Colorectal Cancer Participants

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 Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Francisco
  • Texas
    • Houston, Texas, United States, 77030
      • University of Texas MD Anderson Cancer Center
    • Houston, Texas, United States, 77026
      • Lyndon B. Johnson General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients of MD Anderson Colorectal Center and their caregivers recruited by study staff.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Colorectal Cancer Participants; Colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.	Behavioral: Interviews - Colorectal Cancer Participants; Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.; Behavioral: Questionnaire; Questionnaire completion asking general health and demographic questions.; Other Names: Survey; Behavioral: Focus Groups; 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.
Caregivers of Colorectal Cancer Participants; Caregivers of colorectal cancer participants undergoing follow-up after curative resection of colorectal cancer.	Behavioral: Interviews - Colorectal Cancer Participants; Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.; Behavioral: Focus Groups; 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.; Behavioral: Interviews - Caregivers of Colorectal Cancer Participants; Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: Patient-Centered Outcomes Research Institute; Alliance for Clinical Trials in Oncology
• Investigators: Principal Investigator: Robert Volk, PHD, M.D. Anderson Cancer Center; Study Chair: George J. Chang, MD,MS, M.D. Anderson Cancer Center

Publications and helpful links

General 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.
• 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.

Helpful Links

• University of Texas MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2014
• Primary Completion (Actual): January 13, 2022
• Study Completion (Actual): January 13, 2022

Study Registration Dates

• First Submitted: August 13, 2014
• First Submitted That Met QC Criteria: August 13, 2014
• First Posted (Estimate): August 15, 2014

Study Record Updates

• Last Update Posted (Actual): February 15, 2022
• Last Update Submitted That Met QC Criteria: February 11, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Caregivers; CRC; Questionnaires; Surveys; Interviews; Focus groups; Curative resection of colorectal cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: PA13-1002; CE13-04-6855 (Other Grant/Funding Number: Patient-Centered Outcomes Research Institute)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No