Quality of Life With Esophageal Stent Trial

Esophageal Cancer Clinical Trial

— QUEST  

Official title:

Prospective, Randomized Trial of the Effects on HRQoL, Cost-Utility and Reintervention Rate, of Nurse Home Visits, in Patients With SEMS Treated Malignant Disease in the Esophagus and Cardia.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01044511
• Other study ID #: QUEST- AFD A
• Status: Recruiting
• Phase: N/A
• First received: January 4, 2010
• Last updated: November 21, 2011
• Start date: January 2010
• Est. completion date: March 2012

Study information

• Verified date: November 2011
• Source: Odense University Hospital
• Contact: Ole Steen Bjerring, MD
• Phone: + 45 23 84 06 96
• Email: steenbjerring[@]gmail.com
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to compare, specialist nurse home visits in patients with inoperable cancer in the esophagus or cardia, who are palliated with Self Expanding Metal Stent, to standard patient contact with regards to quality of life, number and character of reinterventions and cost-effectiveness.

Description:

The aim of this study is to compare, specialist nurse home visits in patients with inoperable cancer in the esophagus or gastro-esophageal junction (cardia), who are palliated with Self Expanding Metal Stent, to standard patient contact with regards to quality of life, number and character of reinterventions and cost-effectiveness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Malignant obstruction of esophagus or cardia treated with SEMS due to non-operable disease.

Exclusion Criteria:

• Mentally unable to fill out questionaire

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Gastro-esophageal Junction Cancer

Intervention

Behavioral:
• Home visits
home visits by specialist nurse 2 times and 1 phonecall
• standard
hotline

Locations

Country	Name	City	State
Denmark	Afd A, OUH	Odense	Fyn

Sponsors (2)

Lead Sponsor	Collaborator
Michael Bau Mortensen	Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HRQoL, EORTC C-30, EOS-18		2 years	No