Quality of Life With Esophageal Stent Trial | NCT01044511

Studies
Quality of Life With Esophageal Stent Trial

NCT01044511

Sponsor

Michael Bau Mortensen

Status

Unknown status

Last Update Posted

Nov 23, 2011Estimated

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Esophageal Cancer
Gastro-esophageal Junction Cancer

Interventions

Home visits
standard

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Dec 2011Estimated

Completion Date

Mar 2012Estimated

First Submitted Date

Jan 4, 2010

First Submission Date that Met QC Criteria

Jan 7, 2010

First Posted Date

Jan 8, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 21, 2011

Last Update Posted Date

Nov 23, 2011Estimated

Name	Class
Odense University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Home visit	Experimental	After SEMS placement, 2 home visits and a phonecall are made by a specialist nurse	Behavioral: Home visits
Standard	Active Comparator	Standard contact via Hotline and traditional referring methods	Behavioral: standard

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Home visits	Behavioral	home visits by specialist nurse 2 times and 1 phonecall	Home visit

Measure	Description	Time Frame
HRQoL, EORTC C-30, EOS-18		2 years

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ole Steen Bjerring, MD	Contact	+ 45 23 84 06 96		steenbjerring@gmail.com
Michael B Mortensen, MD, PhD	Contact			m.bau@dadlnet.dk

Overall Officials

Name	Affiliation	Role
Michael B Mortensen, MD,PhD	Afd A, OUH	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Afd A, OUH	Recruiting	Odense	Fyn	5000	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D004938	Esophageal Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D006792	House Calls

Ancestor Terms

ID	Term
D011364	Professional Practice
D009934	Organization and Administration
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided