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

Completed

• Conditions: Esophageal Cancer; Dysphagia, Esophageal
• Interventions: Other: Validation of different dysphagia scores

• 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

Arm && Interventions

Group	Intervention	Description
Patients	Validation of different dysphagia scores	Patients with oesophageal cancer and dysphagia
Controls	Validation of different dysphagia scores	Healthy Controls with no known dysphagia

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