Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis (0000-041)

NCT ID: NCT00211601

Last Updated: 2015-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-08-31
• Study Completion Date: 2005-12-31

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.

Conditions

Chemotherapy Induced Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Interventions

Disease Management Assessment

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

041

Identifier Type: -

Identifier Source: secondary_id

2005_072

Identifier Type: -

Identifier Source: secondary_id

0000-041

Identifier Type: -

Identifier Source: org_study_id