Nausea or Vomiting in Patients Who Are Receiving Chemotherapy for Breast Cancer or Lung Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00416689
First received: December 27, 2006
Last updated: September 29, 2013
Last verified: September 2013

December 27, 2006
September 29, 2013
April 2000
March 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00416689 on ClinicalTrials.gov Archive Site
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Nausea or Vomiting in Patients Who Are Receiving Chemotherapy for Breast Cancer or Lung Cancer
Determination of Utilities for Control of Chemotherapy-Induced Nausea or Vomiting

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample

Breast or lung cancer patients undergoing chemotherapy

  • Breast Cancer
  • Lung Cancer
  • Nausea and Vomiting
  • Procedure: assessment of therapy complications
  • Procedure: quality-of-life assessment
Breast or lung CA pt undergoing chemoTx
Interventions:
  • Procedure: assessment of therapy complications
  • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
January 2006
March 2003   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00416689
CDR0000460041, U10CA031946, CALGB-309801
No
Alliance for Clinical Trials in Oncology
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Study Chair: Steven M. Grunberg, MD University of Vermont
Alliance for Clinical Trials in Oncology
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP