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

NCT ID: NCT03066167

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

64 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-11-30

Study Completion Date

2020-07-23

Brief Summary

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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

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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.

Conditions

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Dysphagia, Esophageal Esophageal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients with oesophageal cancer and dysphagia

Validation of different dysphagia scores

Intervention Type OTHER

Controls

Healthy Controls with no known dysphagia

Validation of different dysphagia scores

Intervention Type OTHER

Interventions

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Validation of different dysphagia scores

Intervention Type OTHER

Other Intervention Names

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Validation to the Swedish language

Eligibility Criteria

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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

* No consent
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role collaborator

The Göteborg Medical Society, Sweden

UNKNOWN

Sponsor Role collaborator

Vastra Gotaland Region

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Surgical Department, Sahlgrenska University Hospital

Gothenburg, Västra Götalandsregionen, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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janpe4(2)

Identifier Type: -

Identifier Source: org_study_id

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