Quality of Life With Esophageal Stent Trial (QUEST)
This study is currently recruiting participants.
Verified November 2011 by Odense University Hospital
Sponsor:
Michael Bau Mortensen
Collaborator:
Odense University Hospital
Information provided by (Responsible Party):
Michael Bau Mortensen, Odense University Hospital
ClinicalTrials.gov Identifier:
NCT01044511
First received: January 4, 2010
Last updated: November 21, 2011
Last verified: November 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | January 4, 2010 | ||||||||
| Last Updated Date | November 21, 2011 | ||||||||
| Start Date ICMJE | January 2010 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
HRQoL, EORTC C-30, EOS-18 [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01044511 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Quality of Life With Esophageal Stent Trial | ||||||||
| Official Title ICMJE | 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. | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
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| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Estimated Completion Date | March 2012 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Denmark | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01044511 | ||||||||
| Other Study ID Numbers ICMJE | QUEST- AFD A | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Michael Bau Mortensen, Odense University Hospital | ||||||||
| Study Sponsor ICMJE | Michael Bau Mortensen | ||||||||
| Collaborators ICMJE | Odense University Hospital | ||||||||
| Investigators ICMJE |
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| Information Provided By | Odense University Hospital | ||||||||
| Verification Date | November 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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