Nausea or Vomiting in Patients Who Are Receiving Chemotherapy for Breast Cancer or Lung Cancer
RATIONALE: Understanding how nausea or vomiting caused by chemotherapy effects a patient's 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.
Nausea and Vomiting
Procedure: assessment of therapy complications
Procedure: quality-of-life assessment
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Determination of Utilities for Control of Chemotherapy-Induced Nausea or Vomiting|
|Study Start Date:||April 2000|
|Study Completion Date:||January 2006|
|Primary Completion Date:||March 2003 (Final data collection date for primary outcome measure)|
|Breast or lung CA pt undergoing chemoTx||Procedure: assessment of therapy complications Procedure: quality-of-life assessment|
- 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.
PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416689
|Study Chair:||Steven M. Grunberg, MD||University of Vermont|