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

Completed

• Conditions: Esophageal Cancer; Dysphagia, Esophageal

• Registration Number: NCT03066167
• Lead Sponsor: Vastra Gotaland Region

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 Timeline

• Study Start: 2010-11
• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-02-28
• Status Verified: 2020-07
• Primary Completion: 2020-07-23
• Study Completion: 2020-07-23
• Last Update Submitted: 2020-07-24
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of dysphagia scores	10-14 days
Translation of scores to the Swedish language	10-14 days

Trial Locations

Locations (1)

Surgical Department, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Västra Götalandsregionen, Sweden