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.
18 Years
N/A
Both
Esophageal Cancer, Gastro-esophageal Junction Cancer
Trial Information
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.
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.
Inclusion Criteria:
- Malignant obstruction of esophagus or cardia treated with SEMS due to non-operable
disease.
Exclusion Criteria:
- Mentally unable to fill out questionaire
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Outcome Measure:
HRQoL, EORTC C-30, EOS-18
Outcome Time Frame:
2 years
Safety Issue:
No
Principal Investigator
Michael B Mortensen, MD,PhD
Investigator Role:
Study Director
Investigator Affiliation:
Afd A, OUH
Authority:
Denmark: The Danish National Committee on Biomedical Research Ethics
Study ID:
QUEST- AFD A
NCT ID:
NCT01044511
Start Date:
January 2010
Completion Date:
March 2012
Related Keywords:
- Esophageal Cancer
- Gastro-esophageal Junction Cancer
- Esophageal cancer
- Cardia cancer
- Health Related quality of Life
- SEMS
- Home visits
- Esophageal Diseases
- Esophageal Neoplasms
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