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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03066167
• Other study ID #: janpe4(2)
• Status: Completed
• Start date: November 2010
• Est. completion date: July 23, 2020

Study information

• Verified date: July 2020
• Source: Vastra Gotaland Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 23, 2020
• Est. primary completion date: July 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia, Esophageal
• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Other:
• Validation of different dysphagia scores

Locations

Country	Name	City	State
Sweden	Surgical Department, Sahlgrenska University Hospital	Gothenburg	Västra Götalandsregionen

Sponsors (3)

Lead Sponsor	Collaborator
Vastra Gotaland Region	Sahlgrenska University Hospital, Sweden, The Göteborg Medical Society, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of dysphagia scores		10-14 days
Primary	Translation of scores to the Swedish language		10-14 days