NCT01044511

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

1.9 years

First QC Date

January 4, 2010

Last Update Submit

November 21, 2011

Conditions

Esophageal CancerGastro-esophageal Junction Cancer

Keywords

Esophageal cancerCardia cancerHealth Related quality of LifeSEMSHome visits

Outcome Measures

Primary Outcomes (1)

  • HRQoL, EORTC C-30, EOS-18

    2 years

Study Arms (2)

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

Home visitsBEHAVIORAL

home visits by specialist nurse 2 times and 1 phonecall

Also known as: Home visit,, pro active nurse care
Home visit
standardBEHAVIORAL

hotline

Also known as: Phone Hotline, After hours phone line
Standard

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Mentally unable to fill out questionaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afd A, OUH

Odense, Fyn, 5000, Denmark

RECRUITING

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

House Calls

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Professional PracticeOrganization and AdministrationHealth Services Administration

Study Officials

  • Michael B Mortensen, MD,PhD

    Afd A, OUH

    STUDY DIRECTOR

Central Study Contacts

Ole Steen Bjerring, MD

CONTACT

+ 45 23 84 06 96steenbjerring@gmail.com

Michael B Mortensen, MD, PhD

CONTACT

m.bau@dadlnet.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 4, 2010

First Posted

January 8, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2011

Study Completion

March 1, 2012

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations

DK(1)