Longitudinal Study of Symptoms in Colorectal Cancer

M.D. Anderson Cancer Center

Status: Terminated

Conditions: Colorectal Cancer

Treatments: Behavioral: Questionnaires

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT00777192

2007-0637

Details and patient eligibility

About

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.

Full 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.

Enrollment: 509 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with colorectal cancer meeting one of the following criteria: 1. naive to oxaliplatin or to any microtubule stabilizing agents (e.g. Taxol, Abraxane, Ixabepilone) but scheduled for combined oxaliplatine chemotherapy (longitudinal study cohort 1); or 2. during first 5 years from colorectal cancer diagnosis (cross-sectional study cohort). This second cohort may include patients with colorectal cancer from the original 12-month study (the longitudinal cohort), both those who completed the study and those who dropped out. It may also include new patients who did not participate in the longitudinal phase of the study.
2. Patients >= 18 years old.
3. Patients who speak English or Spanish.

Exclusion criteria

1. Cohort 1 patients with a neuropathy score of 1 or greater on the NCI's Common Terminology 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 to physical limitations (e.g., hearing impairment).
4. Cohort 1 patients with a history of inflammatory bowel disease.

Trial design

509 participants in 1 patient group

Symptoms in Colorectal Cancer

Description:

Colorectal Cancer Patients Receiving Oxaliplatin Chemotherapy

Treatment:

Behavioral: Questionnaires