Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis (C-PHONE)

This study has been completed.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT00211601

First received: September 13, 2005

Last updated: October 25, 2009

Last verified: October 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

September 13, 2005

Last Updated Date

October 25, 2009

Start Date ^ICMJE

August 2004

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

CINV at the delayed phase during cycle 2

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00211601 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Treatment for CINV

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis

Official Title ^ICMJE

Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis

Brief Summary

The purpose of this study is to assess whether timely feedback to providers on patient experiences with delayed chemotherapy induced nausea and vomiting (CINV) lead to differences in patient outcomes for subsequent cycles.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label

Condition ^ICMJE

Chemotherapy Induced Nausea and Vomiting

Intervention ^ICMJE

Behavioral: Disease Management Assessment

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1500

Completion Date

December 2005

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Highly or moderately emetogenic chemotherapy planned for at least 2 cycles

Exclusion Criteria:

Concurrent other anti-cancer therapy (e.g. radiation, hormone, etc.); vomiting during the 24 hours prior to first chemotherapy cycle; having a disease/condition or taking medication that may cause emesis

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00211601

Other Study ID Numbers ^ICMJE

2005_072, 041

Has Data Monitoring Committee

Not Provided

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Verification Date

October 2009

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

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