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Status unknownNCT01044511QUESTUpdated Nov 23, 2011

Quality of Life With Esophageal Stent Trial

An interventional study of Home visits and standard in Esophageal Cancer and Gastro-esophageal Junction Cancer, sponsored by Michael Bau Mortensen. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-11-23.

Sponsored by Michael Bau Mortensen · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Nov 2011), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Esophageal Cancer
  • Gastro-esophageal Junction Cancer

Keywords

  • Esophageal cancer
  • Cardia cancer
  • Health Related quality of Life
  • SEMS
  • Home visits
03

In context

Esophageal Neoplasms

1,593 studies on the registry are indexed under Esophageal Neoplasms; 460 are open to participants now.

This study's planned enrollment of 80 is above the median of 58 across 1,170 interventional studies indexed under Esophageal Neoplasms.

Browse Esophageal Neoplasms studies →

Lead sponsor

Michael Bau Mortensen is the lead sponsor of 8 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Mentally unable to fill out questionaire
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Home visit

    After SEMS placement, 2 home visits and a phonecall are made by a specialist nurse

    Behavioral: Home visits

  • Active comparator
    Standard

    Standard contact via Hotline and traditional referring methods

    Behavioral: standard

Interventions

  • BehavioralHome visits

    home visits by specialist nurse 2 times and 1 phonecall

    Also known as: Home visit,, pro active nurse care

  • Behavioralstandard

    hotline

    Also known as: Phone Hotline, After hours phone line

06

What researchers measure

Primary outcomes

  1. HRQoL, EORTC C-30, EOS-18

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01044511
Lead sponsor
Michael Bau Mortensen
Collaborators
Odense University Hospital
Responsible party
Michael Bau Mortensen (MD, PhD, Odense University Hospital) — Sponsor-investigator
First posted
Jan 8, 2010
Start date
Jan 2010
Primary completion
Dec 2011 (estimated)
Completion
Mar 2012 (estimated)
Last update
Nov 23, 2011

Study contacts

Ole Steen Bjerring, MD
Contact
steenbjerring@gmail.com
+ 45 23 84 06 96
Michael B Mortensen, MD, PhD
Contact
m.bau@dadlnet.dk
Michael B Mortensen, MD,PhD
study director · Afd A, OUH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2011. You cannot join it, but the record below documents what was studied.

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