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Quality of Life With Esophageal Stent Trial (QUEST)

This study is currently recruiting participants.
Verified November 2011 by Odense University Hospital
Sponsor:
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Michael Bau Mortensen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01044511
First received: January 4, 2010
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Esophageal Cancer
Gastro-esophageal Junction Cancer
 Behavioral: Home visits
Behavioral: standard

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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • HRQoL, EORTC C-30, EOS-18 [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: January 2010
Estimated Study Completion Date: March 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Home visit
After SEMS placement, 2 home visits and a phonecall are made by a specialist nurse
 Behavioral: Home visits
home visits by specialist nurse 2 times and 1 phonecall
Other Names:
  • Home visit,
  • pro active nurse care
Active Comparator: Standard
Standard contact via Hotline and traditional referring methods
 Behavioral: standard
hotline
Other Names:
  • Phone Hotline
  • After hours phone line

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Mentally unable to fill out questionaire
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01044511

Contacts
Contact: Ole Steen Bjerring, MD + 45 23 84 06 96 steenbjerring@gmail.com
Contact: Michael B Mortensen, MD, PhD m.bau@dadlnet.dk

Locations
Denmark
Afd A, OUH Recruiting
Odense, Fyn, Denmark, 5000
Contact: Bjerring, MD         steenbjerring@gmail.com    
Contact: Mortensen, MD, PhD         m.bau@dadlnet.dk    
Sponsors and Collaborators
Michael Bau Mortensen
Odense University Hospital
Investigators
Study Director: Michael B Mortensen, MD,PhD Afd A, OUH
  More Information

No publications provided

Responsible Party: Michael Bau Mortensen, MD, PhD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT01044511     History of Changes
Other Study ID Numbers: QUEST- AFD A
Study First Received: January 4, 2010
Last Updated: November 21, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Odense University Hospital:
Esophageal cancer
Cardia cancer
Health Related quality of Life
SEMS
Home visits

Additional relevant MeSH terms:
Esophageal Diseases
Esophageal Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on May 19, 2013