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.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- HRQoL, EORTC C-30, EOS-18
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Malignant obstruction of esophagus or cardia treated with SEMS due to non-operable disease.
Exclusion Criteria
- •Mentally unable to fill out questionaire
Arms & Interventions
Home visit
After SEMS placement, 2 home visits and a phonecall are made by a specialist nurse
Intervention: Home visits (Behavioral)
Standard
Standard contact via Hotline and traditional referring methods
Intervention: standard (Behavioral)
Outcomes
Primary Outcomes
HRQoL, EORTC C-30, EOS-18
Time Frame: 2 years
Secondary Outcomes
No secondary outcomes reported
Investigators
Michael Bau Mortensen
MD, PhD
Odense University Hospital