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

Alliance for Clinical Trials in Oncology logo

Alliance for Clinical Trials in Oncology

Status

Completed

Conditions

Breast Cancer
Nausea and Vomiting
Lung Cancer

Treatments

Procedure: quality-of-life assessment
Procedure: assessment of therapy complications

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT00416689
CALGB-309801
CDR0000460041 (Registry Identifier)
U10CA031946 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

99 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

99 participants in 1 patient group

Breast or lung CA pt undergoing chemoTx
Treatment:
Procedure: quality-of-life assessment
Procedure: assessment of therapy complications

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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