- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07328347
Improving Dental Care for Patients With Head and Neck Tumors (OncoDent)
A Simulation Experiment to Improve Dental Care for Patients With Head and Neck Tumors
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a prospective survey-based study using a pre-post design. Patients with head and neck cancer and practicing dentists are invited to participate. Patient recruitment is carried out through existing self-help networks and direct personal contact. National and regional self-help groups for head and neck cancer patients are contacted and asked to disseminate information about the study, including a study information sheet and a QR code linking to the online questionnaire, via their communication channels. Dentists receive an invitation letter containing the QR code to the online questionnaire by postal mail.
Participation in the study is voluntary and anonymous. By completing the online questionnaire, participants provide informed consent to participate. Due to the anonymous nature of data collection, withdrawal from the study is no longer possible after submission of the questionnaire. The survey is conducted in accordance with the data protection requirements of the Data Protection Officer of University Medical Center Göttingen, and participants are informed accordingly.
All participants initially complete a baseline questionnaire (pre-assessment) collecting demographic data as well as information on knowledge, behavior, attitudes, and experiences related to dental care for patients with head and neck cancer. Subsequently, a written educational intervention is provided. For patients, this consists of concise summaries of patient guidelines on oral cavity cancer, pharyngeal cancer, and supportive care. For dentists, the intervention includes concise summaries of relevant S3 clinical practice guidelines covering diagnosis, treatment, prevention, and follow-up of laryngeal cancer, oro- and hypopharyngeal cancer, oral cavity cancer, implant-based oral rehabilitation after head and neck radiotherapy, and supportive care in oncology.
The survey for each participant group (patients and dentists) is conducted as a single, continuous, and structured session. After accessing the educational intervention, participants are no longer able to modify their responses to the pre-assessment questionnaire. A second questionnaire with identical content is then completed (post-assessment). The effect of the educational intervention is evaluated by calculating the change (Δ) between pre- and post-assessment values.
The development of the educational interventions was informed by findings from a preceding qualitative interview study involving dentists, otolaryngologists, radiation oncologists, and patients with head and neck cancer.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Felix Matschner, Dr. MSc
- Phone Number: +49 551 39-60870
- Email: felix.marschner@med.uni-goettingen.de
Study Locations
-
-
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Göttingen, Germany, 37075
- Recruiting
- University Medical Center Göttingen
-
Contact:
- Felix Marschner, Dr. med. dent., Mac
- Phone Number: +49 551 / 39-60870
- Email: felix.marschner@med.uni-goettingen.de
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients aged 18 years or older with head and neck cancer whose health status allows completion of a questionnaire
- Practicing dentists in Germany registered in the OAK-Verlag address database
Exclusion Criteria:
- Lack of consent to participate
- Insufficient German language skills that prevent completion of the questionnaire
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Patients With Head and Neck Cancer/Dentists - Educational Information Intervention
Patients with head and neck cancer and practicing dentists in Germany participate in an anonymous, prospective pre-post survey study.
|
Patients with head and neck cancer and practicing dentists in Germany participate in an anonymous, prospective pre-post survey study.
Both groups complete a baseline questionnaire assessing demographic characteristics as well as knowledge, attitudes, experiences, and decision-making related to dental care in the context of head and neck cancer treatment.
Following the baseline assessment, participants receive group-specific, guideline-based written educational information.
After reviewing the educational material, participants complete a post-intervention questionnaire with identical content.
The effect of the educational intervention is evaluated by comparing pre- and post-assessment responses within each group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Knowledge and Decision-Making Regarding Dental Care, Assessed by a Self-Administered Questionnaire (Percentage of Correct Responses)
Time Frame: Immediately after completion of the educational intervention (single study visit)
|
Study outcomes are defined as the effects of the interventions measured using a self-administered questionnaire.
Questionnaire responses are summarized as a percentage score ranging from 0% to 100%, with 100% indicating all responses answered correctly.
For each research question, outcomes are calculated as the change (Δ) in percentage scores between pre-intervention (baseline) and post-intervention assessments.
|
Immediately after completion of the educational intervention (single study visit)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15/11/25
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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