Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416689
Status:
COMPLETED
Last Update Posted:
2016-06-29
First Post:
2006-12-27
Brief Title:
Nausea or Vomiting in Patients Who Are Receiving Chemotherapy for Breast Cancer or Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Determination of Utilities for Control of Chemotherapy-Induced Nausea or Vomiting
Status:
COMPLETED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Understanding how nausea or vomiting caused by chemotherapy effects a patients treatment decisions may help doctors plan better cancer treatment and may help patients live more comfortably
PURPOSE This clinical trial is studying nausea or vomiting in patients who are receiving chemotherapy for breast cancer or lung cancer
PURPOSE This clinical trial is studying nausea or vomiting in patients who are receiving chemotherapy for breast cancer or lung cancer
Detailed Description:
OBJECTIVES
Determine the contribution of nausea or vomiting to the overall importance for a current state of health in patients with breast or lung cancer undergoing chemotherapy
Determine the average importance for various emetic scenarios in these patients
Compare the importance of a specific level of chemotherapy-induced nausea or vomiting defined by the Standard Gamble vs Morrow Assessment of Nausea and Emesis
Determine the feasibility of using a Standard Gamble technique in patients currently undergoing chemotherapy
OUTLINE This is a multicenter study Patients are stratified according to history of chemotherapy-induced nausea or vomiting yes vs no
Patients undergo a structured interview over 1 hour by a trained interviewer at least 2½ weeks after initiation of the most recent course of chemotherapy and before the new course is administered Patients complete a Functional Assessment of Cancer Therapy-General questionnaire and Morrow Assessment of Nausea and Emesis questionnaire during the interview The trained interviewer also administers a Standard Gamble exercise during the interview in which patients are instructed to imagine various amounts of nausea or vomiting as their current state of nausea and vomiting and rank their importance to them They are being asked to answer the question of whether they would choose to accept their current imagined or real state of nausea or vomiting or receive a medication that would result with various probabilities in either perfect health for 2 years or immediate death
Determine the contribution of nausea or vomiting to the overall importance for a current state of health in patients with breast or lung cancer undergoing chemotherapy
Determine the average importance for various emetic scenarios in these patients
Compare the importance of a specific level of chemotherapy-induced nausea or vomiting defined by the Standard Gamble vs Morrow Assessment of Nausea and Emesis
Determine the feasibility of using a Standard Gamble technique in patients currently undergoing chemotherapy
OUTLINE This is a multicenter study Patients are stratified according to history of chemotherapy-induced nausea or vomiting yes vs no
Patients undergo a structured interview over 1 hour by a trained interviewer at least 2½ weeks after initiation of the most recent course of chemotherapy and before the new course is administered Patients complete a Functional Assessment of Cancer Therapy-General questionnaire and Morrow Assessment of Nausea and Emesis questionnaire during the interview The trained interviewer also administers a Standard Gamble exercise during the interview in which patients are instructed to imagine various amounts of nausea or vomiting as their current state of nausea and vomiting and rank their importance to them They are being asked to answer the question of whether they would choose to accept their current imagined or real state of nausea or vomiting or receive a medication that would result with various probabilities in either perfect health for 2 years or immediate death
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000460041 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| U10CA031946 | NIH | None | None |
| CALGB-309801 | None | None | None |