Quality of Life With Esophageal Stent Trial (QUEST)
Primary Purpose
Esophageal Cancer, Gastro-esophageal Junction Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Home visits
standard
Sponsored by
About this trial
This is an interventional supportive care trial for Esophageal Cancer focused on measuring Esophageal cancer, Cardia cancer, Health Related quality of Life, SEMS, Home visits
Eligibility 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
Sites / Locations
- Afd A, OUHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Home visit
Standard
Arm Description
After SEMS placement, 2 home visits and a phonecall are made by a specialist nurse
Standard contact via Hotline and traditional referring methods
Outcomes
Primary Outcome Measures
HRQoL, EORTC C-30, EOS-18
Secondary Outcome Measures
Full Information
NCT ID
NCT01044511
First Posted
January 4, 2010
Last Updated
November 21, 2011
Sponsor
Michael Bau Mortensen
Collaborators
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01044511
Brief Title
Quality of Life With Esophageal Stent Trial
Acronym
QUEST
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.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2011
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
March 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael Bau Mortensen
Collaborators
Odense University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Gastro-esophageal Junction Cancer
Keywords
Esophageal cancer, Cardia cancer, Health Related quality of Life, SEMS, Home visits
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Home visit
Arm Type
Experimental
Arm Description
After SEMS placement, 2 home visits and a phonecall are made by a specialist nurse
Arm Title
Standard
Arm Type
Active Comparator
Arm Description
Standard contact via Hotline and traditional referring methods
Intervention Type
Behavioral
Intervention Name(s)
Home visits
Other Intervention Name(s)
Home visit,, pro active nurse care
Intervention Description
home visits by specialist nurse 2 times and 1 phonecall
Intervention Type
Behavioral
Intervention Name(s)
standard
Other Intervention Name(s)
Phone Hotline, After hours phone line
Intervention Description
hotline
Primary Outcome Measure Information:
Title
HRQoL, EORTC C-30, EOS-18
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ole Steen Bjerring, MD
Phone
+ 45 23 84 06 96
Email
steenbjerring@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michael B Mortensen, MD, PhD
Email
m.bau@dadlnet.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B Mortensen, MD,PhD
Organizational Affiliation
Afd A, OUH
Official's Role
Study Director
Facility Information:
Facility Name
Afd A, OUH
City
Odense
State/Province
Fyn
ZIP/Postal Code
5000
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bjerring, MD
Email
steenbjerring@gmail.com
First Name & Middle Initial & Last Name & Degree
Mortensen, MD, PhD
Email
m.bau@dadlnet.dk
12. IPD Sharing Statement
Learn more about this trial
Quality of Life With Esophageal Stent Trial
We'll reach out to this number within 24 hrs