Dysphagia, EsophagealNCT03066167
Validation of Instruments Used for Assessment of Dysphagia in Patients With Esophageal Cancer
An observational study of Dysphagia, Esophageal and Esophageal Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dysphagia, Esophageal, Esophageal Cancer
- What is being tested?
- Validation of different dysphagia scores
- How many people
- 64 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2010to 23 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients with cancer in the oesophagus and as Controls, healthy volunteers.
Who may be able to join
- Cancer in the gastro-esophageal junction or in the esophagus
- Dysphagia
- Ability to fill in the questionnaires
- Written acceptance of the informed consent
Who cannot join
- Not for-filling inclusion criteria
- No consent
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Surgical Department, Sahlgrenska University Hospital
Gothenburg, Västra Götalandsregionen, 41345
About this study
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.
Read the 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.
- Conditions
- Dysphagia, Esophageal, Esophageal Cancer
- Being tested
- Validation of different dysphagia scores
- Keywords
- Cancer of the gastro-esophageal junction, Watson score, Ogilvie score, Goldschmid score, Validation, Quality of Life
- Medical subject headings
- Deglutition Disorders, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Validation of different dysphagia scoresOther
Also called Validation to the Swedish language
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with oesophageal cancer and dysphagia Receives: Other: Validation of different dysphagia scores | |
| Controls | Healthy Controls with no known dysphagia Receives: Other: Validation of different dysphagia scores |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of dysphagia scores
Measured: 10-14 days
Translation of scores to the Swedish language
Measured: 10-14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study startNov 2010
- Primary completion23 Jul 2020
- Study completion23 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dysphagia, EsophagealStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Collaborators
- Sahlgrenska University Hospital, The Göteborg Medical Society, Sweden
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03066167
- Sponsor's protocol ID
- janpe4(2)
- Status last verified
- Jul 2020
- First submitted
- 23 Feb 2017
- Last updated
- 28 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Instruments Used for Assessment of Dysphagia in Patients With Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03066167
- Acronym / sponsor ID
- janpe4(2)
- Conditions
- Dysphagia, Esophageal, Esophageal Cancer
- Keywords
- Cancer of the gastro-esophageal junction, Watson score, Ogilvie score, Goldschmid score, Validation, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Collaborators
- Sahlgrenska University Hospital, The Göteborg Medical Society, Sweden
- Study start
- Nov 2010 (actual)
- Primary completion
- 23 Jul 2020 (actual)
- Study completion
- 23 Jul 2020 (actual)
- First posted
- 28 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Validation of different dysphagia scoresPatients with oesophageal cancer and dysphagia |
| Controls | – | Other: Validation of different dysphagia scoresHealthy Controls with no known dysphagia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with cancer in the oesophagus and as Controls, healthy volunteers.
Key inclusion criteria (4 listed)
- Cancer in the gastro-esophageal junction or in the esophagus
- Dysphagia
- Ability to fill in the questionnaires
- Written acceptance of the informed consent
Key exclusion criteria (2 listed)
- Not for-filling inclusion criteria
- No consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Validation of different dysphagia scoresAlso: Validation to the Swedish language | Other | Controls, Patients |
Primary outcome
Validation of dysphagia scores
Time frame: 10-14 days
Translation of scores to the Swedish language
Time frame: 10-14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dysphagia, Esophageal and Esophageal Cancer, run by Vastra Gotaland Region at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of dysphagia scores (time frame: 10-14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.