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

Status:	Recruiting
Conditions:	Colorectal Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	21 - Any
Updated:	6/1/2017
Start Date:	July 2014
End Date:	July 2019
Contact:	George J. Chang, MD,MS
Phone:	713-563-1875

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.

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.

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:

We found this trial at

sites

University of California at San Francisco

San Francisco, California 94143

from

San Francisco, CA