A public survey about oral cancer in Northern Italian adults
| ISRCTN | ISRCTN17199640 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17199640 |
- Submission date
- 16/10/2023
- Registration date
- 04/12/2023
- Last edited
- 04/12/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Oral cancer represents one of the most common malignant tumours in the world with an incidence that has tripled in the last 3 years. Mortality of patients with oral cancer is among the highest in oncology. Currently, 5-year survival is less than 50%, and the necessary surgical, radiotherapy and chemotherapy therapies are highly invasive, complex, and debilitating. Today, the only effective prevention strategies aim to control the risk factors to reduce their onset and make an early diagnosis to improve the prognosis. For there to be an early diagnosis, it is essential that people are aware of the pathology including early signs, symptoms, and specialists to contact in case of doubt. Currently, different articles investigate the population’s knowledge of oral cancer in different parts of the world, such as China, Australia, Spain, and Kuwait. However, most of these studies focused on a selected population, such as dental patients or university students. According to their results, controversial data based on the different geographical areas was highlighted and in general, a low level of awareness and knowledge about the pathology, signs, symptoms, and risk factors was highlighted. To the researcher’s knowledge, to date only one previous study investigated the awareness of the pathology in the Italian population, focusing on a single city located in the northeast part of Italy (Trieste). Furthermore, the study was based on an online questionnaire and as highlighted by the study’s authors, more research in different Italian geographical areas is required. The first aim of the present study will be to investigate the general population’s knowledge of oral cancer in the Piedmont area (northwest Italian region) as well as its risk factors and manifestations. The second aim will be to improve the population’s awareness by releasing an informative brochure on the topic to patients who will be enrolled in the study.
Who can participate?
Adult patients aged between 18 and 90 years old who visit pharmacies in the Piedmont area of Italy
What does the study involve?
Each questionnaire, without any sensitive data, will be designed as a multichoice questionnaire with a series of 12 questions to acquire data about the population’s knowledge of oral cancers, including the following topics:
1. Background-related data (age, gender, educational background, frequency of dental check-ups, smoke habits, urban vs rural resident)
2. Oral cancer awareness data (whether they have never heard about oral cancer and the way)
3. Knowledge about oral cancer (risk factors, whether the oral cancer is a malignant or benignant tumour, survival rate, early diagnosis, age of onset, signs and symptoms, specialists to contact in case of suspicions)
4. Information about the channel they would consider more valuable to share more information about oral cancer
What are the possible benefits and risks of participating?
There are no risks of participating. We supposed that most of the individuals did not receive counseling on oral cancer by dentists, physicians, or other health care providers. The benefit will be the improvement in oral cancer knowledge in the Piedmont population.
Where is the study run from?
University of Turin (Italy)
When is the study starting and how long is it expected to run for?
January 2023 to December 2024
Who is funding the study?
Investigator initiated and funded (Italy)
Who is the main contact?
Prof Paolo Giacomo Arduino, paologiacomo.arduino@unito.it
Contact information
Public, Scientific, Principal Investigator
Via Nizza 230
Turin
10100
Italy
 ORCID ID |
0000-0002-8798-7834 |
|---|---|
| Phone | +390116331522 |
| paologiacomo.arduino@unito.it |
Study information
| Study design | Cross-sectional study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Community |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use the contact details below to request a participant information sheet. |
| Scientific title | Knowledge and understanding of oral cancer in adults: a cross-sectional survey in North-Western Italy |
| Study acronym | KnowOC |
| Study objectives | Knowledge of oral cancer is very low in the common population |
| Ethics approval(s) |
Approved 11/09/2023, Ethical Review Board of the University of Turin (Via Verdi 8, Turin, 10100, Italy; +39 116704377; Staff.cba@unito.it), ref: Prot. n. 0494208 |
| Health condition(s) or problem(s) studied | Oral cancer |
| Intervention | The aim of the study is to verify the knowledge on oral cancer and to assess possible differences in awareness and information basing on different demographic and subject-related factors. An anonymous survey will be provided to random subjects attending selected pharmacy in Piedmont region. Forty-five pharmacies (n = 45) will be selected for the purpose. Twenty anonymous questionnaires (n = 20) will be provided to each pharmacy for a total questionnaire number of 900 (n = 900). People who will go to the pharmacies and will meet the following inclusion/exclusion criteria will be asked on a volunteering basis to participate in the study and complete the questionnaire. Ten trained students of pharmacology will provide the questionnaire. Each questionnaire, without any sensitive data, will be designed as a multi-choices questionnaire with a series of 12 questions to acquire data about the population’s knowledge on oral cancers, including the following topics: (1) Background-related data (age, gender, educational background, frequency of dental check-ups, smoke habits, urban vs rural resident); (2) oral cancer awareness data (whether they have never heard about oral cancer and the way); (3) knowledges about oral cancer (risk factors, whether the oral cancer is a malignant or benignant tumour, survival rate, early diagnosis, age of onset, sign and symptoms, specialists to contact in case of suspicions); (4) information about the channel they would consider more valuable to share more information about the oral cancer. At the end of the study, statistical analysis will be performed in order to evaluate the influence of different demographic variables on knowledge of oral cancer and its risk factors. |
| Intervention type | Other |
| Primary outcome measure | Oral cancer knowledge measured using a questionnaire at a single time point. |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/01/2023 |
| Completion date | 31/12/2024 |
Eligibility
| Participant type(s) | Population |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 90 Years |
| Sex | Both |
| Target number of participants | 900 |
| Key inclusion criteria | 1. Age ≥ 18 years old 2. People who go to the pharmacies for any reason 3. Agreement to participate in the study |
| Key exclusion criteria | 1. Aged <18 years old 2. Cognitive deficit 3. Refusal to participate in the study 4. People with an existing diagnosis of oral cancer |
| Date of first enrolment | 01/10/2023 |
| Date of final enrolment | 01/06/2024 |
Locations
Countries of recruitment
- Italy
Study participating centre
Turin
10100
Italy
Sponsor information
University/education
Department of Surgical Sciences
Via Nizza 230
Turin
10100
Italy
| Phone | +39 3356011953 |
|---|---|
| segr_cirdental@unito.it | |
| Website | http://en.unito.it/ |
"ROR" |
https://ror.org/048tbm396 |
Funders
Funder type
Not defined
No information available
Results and Publications
| Intention to publish date | 01/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact and peer-reviewed journal |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the results publication |
Editorial Notes
27/10/2023: Trial's existence confirmed by University of Turin.
