Quality of Life With Esophageal Stent Trial

Not Applicable

• Conditions: Esophageal Cancer; Gastro-esophageal Junction Cancer
• Interventions: Behavioral: Home visits; Behavioral: standard

• Registration Number: NCT01044511
• Lead Sponsor: Michael Bau Mortensen

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-07
• Study First Posted: 2010-01-08
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-21
• Last Update Posted: 2011-11-23
• Primary Completion: 2011-12
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home visit	Home visits	After SEMS placement, 2 home visits and a phonecall are made by a specialist nurse
Standard	standard	Standard contact via Hotline and traditional referring methods

Primary Outcome Measures

Name	Time	Method
HRQoL, EORTC C-30, EOS-18	2 years

Trial Locations

Locations (1)

Afd A, OUH; 🇩🇰 Odense, Fyn, Denmark