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Determination of Utilities for Control of Chemotherapy-Induced Nausea or Vomiting


N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer, Lung Cancer, Nausea and Vomiting

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Trial Information

Determination of Utilities for Control of Chemotherapy-Induced Nausea or Vomiting


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.

Inclusion Criteria


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Steven M. Grunberg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Vermont

Authority:

United States: Federal Government

Study ID:

CDR0000460041

NCT ID:

NCT00416689

Start Date:

April 2000

Completion Date:

January 2006

Related Keywords:

  • Breast Cancer
  • Lung Cancer
  • Nausea and Vomiting
  • 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
  • Breast Neoplasms
  • Lung Neoplasms
  • Nausea
  • Vomiting

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