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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01044511
Other study ID # QUEST- AFD A
Secondary ID
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


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
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