Ignite Creation Date:
2025-12-25 @ 3:38 AM
Ignite Modification Date:
2025-12-26 @ 2:22 AM
Study NCT ID:
NCT00394602
Status:
TERMINATED
Last Update Posted:
2020-01-02
First Post:
2006-10-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Chemoradiation-Induced Nausea and Emesis: Quality of Life
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Chemoradiation-Induced Nausea and Emesis: A Prospective Study to Assess Patient Preferences and Quality of Life
Status:
TERMINATED
Status Verified Date:
2019-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Requested by PI during yearly Continuing Review
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objectives of this study are:
1. To assess the preferences of cancer patients scheduled to receive chemoradiation and caregiver controls for side-effects of chemoradiation.
1. To compare preferences of cancer patients to those of healthy individuals.
2. To compare how patients' preferences for side-effects of chemoradiation change over time.
2. To longitudinally assess the quality of life of cancer patients scheduled to receive chemoradiation.
3. 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.
1. To assess the preferences of cancer patients scheduled to receive chemoradiation and caregiver controls for side-effects of chemoradiation.
1. To compare preferences of cancer patients to those of healthy individuals.
2. To compare how patients' preferences for side-effects of chemoradiation change over time.
2. To longitudinally assess the quality of life of cancer patients scheduled to receive chemoradiation.
3. 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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: