Ignite Creation Date:
2024-05-05 @ 5:07 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00394602
Status:
TERMINATED
Last Update Posted:
2020-01-02
First Post:
2006-10-30
Brief Title:
Chemoradiation-Induced Nausea and Emesis Quality of Life
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
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:
None
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?:
None