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

July 24, 2020 updated by: Vastra Gotaland Region
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

64

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västra Götalandsregionen
      • Gothenburg, Västra Götalandsregionen, Sweden, 41345
        • Surgical Department, Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with cancer in the oesophagus and as Controls, healthy volunteers.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Patients with oesophageal cancer and dysphagia
Other: Validation of different dysphagia scores
Other Names:
  • Validation to the Swedish language
Controls
Healthy Controls with no known dysphagia
Other: Validation of different dysphagia scores
Other Names:
  • Validation to the Swedish language

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Validation of dysphagia scores
Time Frame: 10-14 days
10-14 days
Translation of scores to the Swedish language
Time Frame: 10-14 days
10-14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vastra Gotaland Region

Collaborators

Sahlgrenska University Hospital, Sweden
The Göteborg Medical Society, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2010

Primary Completion (Actual)

July 23, 2020

Study Completion (Actual)

July 23, 2020

Study Registration Dates

First Submitted

February 23, 2017

First Submitted That Met QC Criteria

February 27, 2017

First Posted (Actual)

February 28, 2017

Study Record Updates

Last Update Posted (Actual)

July 28, 2020

Last Update Submitted That Met QC Criteria

July 24, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • janpe4(2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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