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

Sponsor
Vastra Gotaland Region (Other)
Overall Status
Completed
CT.gov ID
NCT03066167
Collaborator
Sahlgrenska University Hospital, Sweden (Other), The Göteborg Medical Society, Sweden (Other)
64
1
116.7
0.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Validation of different dysphagia scores

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 Design

Study Type:
Observational
Actual Enrollment :
64 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Validation of Instruments Used for Assessment of Dysphagia in Patients With Esophageal Cancer
Actual Study Start Date :
Nov 1, 2010
Actual Primary Completion Date :
Jul 23, 2020
Actual Study Completion Date :
Jul 23, 2020

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. Validation of dysphagia scores [10-14 days]

    2. Translation of scores to the Swedish language [10-14 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Surgical Department, Sahlgrenska University Hospital Gothenburg Västra Götalandsregionen Sweden 41345

    Sponsors and Collaborators

    • Vastra Gotaland Region
    • Sahlgrenska University Hospital, Sweden
    • The Göteborg Medical Society, Sweden

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Vastra Gotaland Region
    ClinicalTrials.gov Identifier:
    NCT03066167
    Other Study ID Numbers:
    • janpe4(2)
    First Posted:
    Feb 28, 2017
    Last Update Posted:
    Jul 28, 2020
    Last Verified:
    Jul 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Vastra Gotaland Region
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 28, 2020