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

Completed

• Conditions: Lung Cancer; Nausea and Vomiting; Breast Cancer
• Interventions: Procedure: assessment of therapy complications; Procedure: quality-of-life assessment

• Registration Number: NCT00416689
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

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.

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.

Study Timeline

• Study Start: 2000-04
• Primary Completion: 2003-03
• Study Completion: 2006-01
• Study First Submitted: 2006-12-27
• Study First Submitted QC: 2006-12-27
• Study First Posted: 2006-12-28
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-28
• Last Update Posted: 2016-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast or lung CA pt undergoing chemoTx	assessment of therapy complications	-
Breast or lung CA pt undergoing chemoTx	quality-of-life assessment	-