ORL Cancer
Conditions
Keywords
ORL Cancer, Oral hygiene, Radiotherapy, Written information guide
Brief summary
Feasibility, prospective, monocentric study aiming to evaluate the interest of a written information guide, given and explained by the dental assistant, on the improvement of the oral hygiene of patients with ORL cancer at 3 months post-radiotherapy. The study will be conducted on a population of 44 patients with ORL cancer requiring radiation treatment. Each patient will be followed during 3 months post-radiotherapy (follow-up for up to 12 months post-inclusion).
Interventions
OTHERAccompaniment by the dental assistant.
Inclusion visit (before radiotherapy treatment): * oral hygiene education (prevention of complications related to radiotherapy) will be provided by the dental assistant. * a written information guide on oral hygiene will be given to the patient. * the questionnaire entitled "Motivation and oral hygiene behavior" will be completed by the patient. End of study visit (three months post-radiotherapy): • The "Motivation and oral hygiene behavior" and the satisfaction questionnaires will be completed by the patient.
Sponsors
Institut Claudius Regaud
Ligue contre le cancer, France
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years at study entry. 2. Patient with ORL cancer requiring radiotherapy (+/- associated chemotherapy). 3. Patient with a plaque index \> or = 30%. 4. Patient affiliated to a social security system in France. 5. Patient having signed informed consent prior to inclusion in the study and prior to any specific procedure for the study.
Exclusion criteria
1. Pregnant or lactating women. 2. Any psychological, familial, geographic or sociological condition that does not allow for compliance with the medical follow-up and/or procedures outlined in the study protocol. 3. Patient who has forfeited his/her freedom by administrative or legal award or who is under legal protection (curatorship and guardianship, protection of justice).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of patients with improved oral hygiene between the inclusion visit and 3 months post-radiotherapy. | 3 months per patient | Improvement is defined as a gross decrease of at least 30% in the plaque index between the inclusion visit and 3 months post-radiotherapy. The plaque index will be evaluated using the O'Leary method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction with the oral hygiene information guide and the consultations performed by the dental assistant. | 3 months per patient | It will be evaluated by means of a satisfaction questionnaire. |
| The motivation of the patients towards their oral health. | 3 months per patient | It will be evaluated with the questionnaire "Motivation and oral hygiene behavior". |
Countries
France
Outcome results
None listed