Chemoradiation-Induced Nausea and Emesis: Quality of Life
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00394602|
Recruitment Status : Recruiting
First Posted : November 1, 2006
Last Update Posted : January 16, 2018
The primary objectives of this study are:
To assess the preferences of cancer patients scheduled to receive chemoradiation and caregiver controls for side-effects of chemoradiation.
- To compare preferences of cancer patients to those of healthy individuals.
- To compare how patients' preferences for side-effects of chemoradiation change over time.
- To longitudinally assess the quality of life of cancer patients scheduled to receive chemoradiation.
- To determine the impact of nausea and vomiting associated with chemoradiation on patients' quality of life and evaluate potential change throughout the duration of chemoradiation treatment.
|Condition or disease||Intervention/treatment|
|Gastric Cancer Pancreatic Cancer Cervical Cancer Vulvar Cancer Endometrial Cancer Anal Cancer||Behavioral: Interview Other: Questionnaire|
You will be interviewed about your perceptions of side effects that are related to your chemoradiation treatment. The interview will take about 20 minutes. You will be interviewed at the beginning of your chemoradiation treatment, 3 weeks after treatment starts, and at the first follow-up appointment after chemoradiation treatment ends.
Chemoradiation is a type of cancer treatment that involves both chemotherapy and radiation therapy.
You will also receive a packet of 3 questionnaires to complete at different times during and after treatment. The questionnaires include a quality of life survey that asks about physical, social, and emotional well-being, a self-report symptom evaluation that will ask whether you are experiencing any particular side effects and if so how much it bothers you, and a brief survey to asks questions about anxiety and distress.
The questionnaires should take about 20 minutes each to complete. The questionnaire packet will be given to patients at the beginning of chemoradiation treatment, 3 weeks after treatment starts, the last day of treatment, and at the first follow-up appointment after chemoradiation treatment ends. If the you do not have time to complete the questionnaires, a stamped, addressed envelop will be given so that you can mail the completed packet back to the research team.
Your participation in this research study will be over about 4-6 weeks after chemoradiation treatment ends.
This is an investigational study. Up to 208 individuals (104 patients and 104 caregivers) will take part in this study. All will be enrolled at M. D. Anderson.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Chemoradiation-Induced Nausea and Emesis: A Prospective Study to Assess Patient Preferences and Quality of Life|
|Actual Study Start Date :||April 2004|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||April 2019|
Patients receiving chemoradiation for abdominal-pelvic tumors.
Interview regarding perceptions of side effects that are related to chemoradiation treatment.Other: Questionnaire
3 Questionnaires regarding quality of life given during and after treatment, each taking about 20 minutes to complete.
Other Name: Survey
Healthy controls with no prior cancer diagnosis.
Interview regarding perceptions of side effects that are related to chemoradiation treatment.
- Longitudinal Quality of Life + Symptom Assessment Data [ Time Frame: Survey(s) & Interview(s) at baseline (beginning of chemoradiation treatment), 3 weeks after treatment starts, the last day of treatment, and at the first follow-up appointment after chemoradiation treatment ends. ]Quality of life survey instruments scored according to EORTC QLQ-C30 scoring manual. Patients and controls compared with respect to preference data. The control group preference data collected at only 1 time point, but patient preference data from each time point will be compared to these control group preference data.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00394602
|Contact: Charlotte C. Sun, MD||713-745-4380|
|United States, Texas|
|University of Texas MD Anderson Cancer Center||Recruiting|
|Houston, Texas, United States, 77030|
|Principal Investigator: Charlotte C. Sun, MD|
|Principal Investigator:||Charlotte C. Sun, MD||M.D. Anderson Cancer Center|