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Completed

NCT Number: NCT03066167

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

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Surgical Department, Sahlgrenska University Hospital

Gothenburg, Västra Götalandsregionen, 41345, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Validation of different dysphagia scores

Other

Other names: Validation to the Swedish language

Primary outcomes

  1. Validation of dysphagia scores

    Time frame: 10-14 days

  2. Translation of scores to the Swedish language

    Time frame: 10-14 days

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Collaborators

  • Sahlgrenska University Hospital
  • The Göteborg Medical Society, Sweden

Registry information

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Feb 28, 2017
Registry last updated
Jul 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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