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Clinical Trials/NCT03066167
NCT03066167
Completed
Not Applicable

Validation of Instruments Used for Assessment of Dysphagia in Patients With Esophageal Cancer

Vastra Gotaland Region1 site in 1 country64 target enrollmentStarted: November 2010Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Vastra Gotaland Region
Enrollment
64
Locations
1
Primary Endpoint
Validation of dysphagia scores

Overview

Brief Summary

This study validates 3 well known dysphagia scores for dysphagia due to malignancies of the oesophagus and gastro-oesophageal junction and to the Swedish language.

Detailed Description

In the present study, our aim was to firstly, validate 3 commonly used scales for use in patients with dysphagia due to malignancy, and secondly, to validate them in the Swedish language. The 3 scales were: The Watson dysphagia scale, which was developed in studies on surgical treatment of reflux disease. It consists of questions about food with 9 different viscosity and solidity and the patient answer if they have problems with a specific food: never, sometimes or always when ingesting this. The scores are added and provides a range of 0-45 where 45 is the worst possible dysphagia. The Ogilvie score is a 5-graded scale 0-4 where 4 is total inability to swallow. The Goldschmid score is graded from 0-5 where 0 is inability to swallow and 5 is normal function. QoL was measured with validated instruments originating from the European Organization for Research and Treatment of Cancer (EORTC), which has a generic instrument that measures global QoL in patients with cancer (QLQ-C30) and a more symptom-specific instrument that is developed for cancer in the oesophagus and stomach (QLQ-OG25). These are well known, validated instruments that also have normal reference values for the healthy population. The symptom specific instrument QLQ-OG25 includes a dysphagia module consisting of 3 questions which is validated to malignant disease and food intake with the help of expert groups and deep interviews with patients.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Cancer in the gastro-esophageal junction or in the esophagus
  • Dysphagia
  • Ability to fill in the questionnaires
  • Written acceptance of the informed consent

Exclusion Criteria

  • Not for-filling inclusion criteria
  • No consent

Outcomes

Primary Outcomes

Validation of dysphagia scores

Time Frame: 10-14 days

Translation of scores to the Swedish language

Time Frame: 10-14 days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Vastra Gotaland Region
Sponsor Class
Other Gov
Responsible Party
Sponsor

Study Sites (1)

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