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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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

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

steenbjerring@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Michael B Mortensen, MD, PhD

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

steenbjerring@gmail.com

First Name & Middle Initial & Last Name & Degree

Mortensen, MD, PhD

m.bau@dadlnet.dk

12. IPD Sharing Statement

Learn more about this trial

Quality of Life With Esophageal Stent Trial

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