Quality of Life With Esophageal Stent Trial (QUEST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Odense University Hospital.
Recruitment status was  Recruiting
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

January 4, 2010
November 21, 2011
January 2010
December 2011   (final data collection date for primary outcome measure)
HRQoL, EORTC C-30, EOS-18 [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01044511 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Quality of Life With Esophageal Stent Trial
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.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
  • Esophageal Cancer
  • Gastro-esophageal Junction Cancer
  • Behavioral: Home visits
    home visits by specialist nurse 2 times and 1 phonecall
    Other Names:
    • Home visit,
    • pro active nurse care
  • Behavioral: standard
    hotline
    Other Names:
    • Phone Hotline
    • After hours phone line
  • Experimental: Home visit
    After SEMS placement, 2 home visits and a phonecall are made by a specialist nurse
    Intervention: Behavioral: Home visits
  • Active Comparator: Standard
    Standard contact via Hotline and traditional referring methods
    Intervention: Behavioral: standard
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
March 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Mentally unable to fill out questionaire
Both
18 Years and older
No
Contact: Ole Steen Bjerring, MD + 45 23 84 06 96 steenbjerring@gmail.com
Contact: Michael B Mortensen, MD, PhD m.bau@dadlnet.dk
Denmark
 
NCT01044511
QUEST- AFD A
No
Michael Bau Mortensen, Odense University Hospital
Michael Bau Mortensen
Odense University Hospital
Study Director: Michael B Mortensen, MD,PhD Afd A, OUH
Odense University Hospital
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP