Nausea or Vomiting in Patients Who Are Receiving Chemotherapy for Breast Cancer or Lung Cancer
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Lung Cancer Nausea and Vomiting |
Procedure: assessment of therapy complications Procedure: quality-of-life assessment |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Determination of Utilities for Control of Chemotherapy-Induced Nausea or Vomiting |
| Enrollment: | 99 |
| Study Start Date: | April 2000 |
| Study Completion Date: | January 2006 |
| Primary Completion Date: | March 2003 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Breast or lung CA pt undergoing chemoTx | Procedure: assessment of therapy complications Procedure: quality-of-life assessment |
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.
PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Breast or lung cancer patients undergoing chemotherapy
DISEASE CHARACTERISTICS:
- Diagnosis of breast cancer or lung cancer
Must be undergoing chemotherapy with each course lasting 3-6 weeks AND meets all of the following criteria:
- Completed ≥ 1 course with ≥ 1 additional course planned
- At least 2½ weeks since initiation of the most recent course of chemotherapy
PATIENT CHARACTERISTICS:
- Common Toxicity Criteria performance status 0-2
- Must have command of written and/or spoken English
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Monica M Bertagnolli, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00416689 History of Changes |
| Other Study ID Numbers: | CDR0000460041, U10CA031946, CALGB-309801 |
| Study First Received: | December 27, 2006 |
| Last Updated: | February 28, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by Cancer and Leukemia Group B:
|
nausea and vomiting pulmonary carcinoid tumor recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
recurrent non-small cell lung cancer stage I non-small cell lung cancer stage II non-small cell lung cancer stage IIIA non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer extensive stage small cell lung cancer limited stage small cell lung cancer recurrent small cell lung cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Lung Neoplasms Nausea Vomiting Neoplasms by Site Neoplasms Breast Diseases |
Skin Diseases Respiratory Tract Neoplasms Thoracic Neoplasms Lung Diseases Respiratory Tract Diseases Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on May 23, 2013