Nausea or Vomiting in Patients Who Are Receiving Chemotherapy for Breast Cancer or Lung Cancer
NCT ID: NCT00416689
Last Updated: 2016-06-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
99 participants
OBSERVATIONAL
2000-04-30
2006-01-31
Brief Summary
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PURPOSE: This clinical trial is studying nausea or vomiting in patients who are receiving chemotherapy for breast cancer or lung cancer.
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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Breast or lung CA pt undergoing chemoTx
assessment of therapy complications
quality-of-life assessment
Interventions
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assessment of therapy complications
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Alliance for Clinical Trials in Oncology
OTHER
Responsible Party
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Principal Investigators
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Steven Grunberg, MD
Role: STUDY_CHAIR
University of Vermont Medical Center
Other Identifiers
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CALGB-309801
Identifier Type: -
Identifier Source: secondary_id
CDR0000460041
Identifier Type: REGISTRY
Identifier Source: secondary_id
CALGB-309801
Identifier Type: -
Identifier Source: org_study_id
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