Longitudinal Study of Symptoms in Colorectal Cancer

Last updated: May 24, 2019
Sponsor: M.D. Anderson Cancer Center
Overall Status: Terminated

Phase

N/A

Condition

Rectal Cancer

Colon Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT00777192
2007-0637
  • Ages > 18
  • All Genders

Study Summary

The goal of this research study is to learn more about the pain and/or other symptoms that patients may experience within five years from CRC diagnosis. Researchers also want to learn how genetic differences may affect the symptoms patients experience from cancer and cancer therapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with colorectal cancer meeting one of the following criteria: 1. naive tooxaliplatin or to any microtubule stabilizing agents (e.g. Taxol, Abraxane,Ixabepilone) but scheduled for combined oxaliplatine chemotherapy (longitudinal studycohort 1); or 2. during first 5 years from colorectal cancer diagnosis (cross-sectional study cohort). This second cohort may include patients withcolorectal cancer from the original 12-month study (the longitudinal cohort), boththose who completed the study and those who dropped out. It may also include newpatients who did not participate in the longitudinal phase of the study.

  2. Patients >= 18 years old.

  3. Patients who speak English or Spanish.

Exclusion

Exclusion Criteria:

  1. Cohort 1 patients with a neuropathy score of 1 or greater on the NCI's CommonTerminology Criteria (CTCv3.0).

  2. Patients who do not understand the intent of the study.

  3. Cohort 1 patients unable to use the interactive voice response (IVR) system due tophysical limitations (e.g., hearing impairment).

  4. Cohort 1 patients with a history of inflammatory bowel disease.

Study Design

Total Participants: 509
Study Start date:
August 01, 2008
Estimated Completion Date:
December 27, 2018

Study Description

If you agree to take part in this study, you will complete 5 questionnaires during a regularly scheduled visit. The questionnaires are designed to measure pain and other symptoms, your mood, and your quality of life.

You will also give a tissue sample by inserting a cotton tipped swab into your mouth and rubbing firmly against the inside of your cheek or underneath your lower or upper lip for about 1 minute at the most.

Completing the 5 questionnaires and the swab sample should take about 30 minutes.

Length of Study:

After you complete the questionnaires and the swab sample collection, your active participation in this study will be over.

This is an investigational study.

Up to 500 patients will take part in this study. All will be enrolled at MD Anderson.

Connect with a study center

  • University of Texas MD Anderson Cancer Center

    Houston, Texas 77030
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.