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Quality of Life With Esophageal Stent Trial

NCT ID: NCT01044511

Last Updated: 2011-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2012-03-31

Brief Summary

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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

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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.

Conditions

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Esophageal Cancer Gastro-esophageal Junction Cancer

Keywords

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Esophageal cancer Cardia cancer Health Related quality of Life SEMS Home visits

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Home visit

After SEMS placement, 2 home visits and a phonecall are made by a specialist nurse

Group Type EXPERIMENTAL

Home visits

Intervention Type BEHAVIORAL

home visits by specialist nurse 2 times and 1 phonecall

Standard

Standard contact via Hotline and traditional referring methods

Group Type ACTIVE_COMPARATOR

standard

Intervention Type BEHAVIORAL

hotline

Interventions

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Home visits

home visits by specialist nurse 2 times and 1 phonecall

Intervention Type BEHAVIORAL

standard

hotline

Intervention Type BEHAVIORAL

Other Intervention Names

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Home visit, pro active nurse care Phone Hotline After hours phone line

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Mentally unable to fill out questionaire
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role collaborator

Michael Bau Mortensen

OTHER

Sponsor Role lead

Responsible Party

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Michael Bau Mortensen

MD, PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michael B Mortensen, MD,PhD

Role: STUDY_DIRECTOR

Afd A, OUH

Locations

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Afd A, OUH

Odense, Fyn, Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Ole Steen Bjerring, MD

Role: CONTACT

Phone: + 45 23 84 06 96

Email: [email protected]

Michael B Mortensen, MD, PhD

Role: CONTACT

Email: [email protected]

Facility Contacts

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Bjerring, MD

Role: primary

Mortensen, MD, PhD

Role: backup

Other Identifiers

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QUEST- AFD A

Identifier Type: -

Identifier Source: org_study_id