Longitudinal Study of Symptoms in Colorectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

509 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-08-31

Study Completion Date

2018-12-27

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Symptoms in Colorectal Cancer

Colorectal Cancer Patients Receiving Oxaliplatin Chemotherapy

Questionnaires

Intervention Type BEHAVIORAL

20 Minute Questionnaires beginning Visit 1, to measure pain/other symptoms, mood, and quality of life

Interventions

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Questionnaires

20 Minute Questionnaires beginning Visit 1, to measure pain/other symptoms, mood, and quality of life

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No