Oral Cavity Carcinoma Clinical Trial
Official title:
Behavior Changing Intervention for Smokeless Tobacco and Betel Quid Use in Adolescents: A Cluster-Randomized Trial
Verified date | July 2019 |
Source | Dow University of Health Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Smokeless tobacco (SLT) is a known risk factor for Oral, Pharyngeal and Esophageal carcinoma.
Three-quarters global SLT consumption is among the South Asian Population. The habit of SLT
chewing commences at a very young age which has an underpinning of socio-cultural dimension
in South Asian population which perhaps due to its more addictive potential, has more
dependency. Youth also perceives SLT as a part of confectionery, which is socially served in
South Asian ceremonies. There exists very little or no evidence regarding efficacy of SLT
cessation interventions in this population. Most of the existing interventions are based in
western world with little or no cultural sensitivities pertinent to South Asia. In this
study, a culturally rooted behavior changing intervention (BCI) to alter SLT use prevalence,
perceptions pertinent to the deleterious effects of SLT use in the etiology of oral cancers
and help youth quit SLT in Karachi, Pakistan.
Baseline demography and SLT use prevalence will be ascertained among 11-16-year-old school
going children from both government and private schools. Multi stage cluster sampling will
randomly recruit forty clusters (schools) from within 6 districts of Karachi, which will then
be divided into intervention and control groups (clusters) using block randomization based on
proportionate number of each school type present (Government and Private).
Both groups' participants will complete all questionnaires pre and post intervention as
described elsewhere and will also undergo screening for oral cancer and oral potentially
malignant lesions (OPMLs). Students in intervention cluster will be given BCI and printed
pamphlets along with a gift pack (reminder for SLT quit, a branded tooth paste and a tooth
brush) while students in control cluster will only differ in that they will not be exposed to
BCI.
BCI was designed after reviewing literature and consulting specialist group for all untoward
effects of SLT use in Oral Cavity that have a potential of transforming into oral carcinoma.
A follow up after 12 weeks will be conducted to re-assess their SLT use prevalence,
perceptions regarding hazardous effects of SLT use in oral cavity, dependency on SLT and
success in quit (among users in both groups), and perception regarding warning labels on SLT
product packet
Status | Completed |
Enrollment | 2200 |
Est. completion date | December 30, 2018 |
Est. primary completion date | October 30, 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 11 Years to 16 Years |
Eligibility |
Inclusion Criteria: • 11-16 years school going children with NO diagnosed oral cancer Exclusion Criteria: - Students younger or older than mentioned ages - Diagnosed Oral Cancer patients |
Country | Name | City | State |
---|---|---|---|
Pakistan | DOW University of Health Sciences | Karachi | Sind |
Lead Sponsor | Collaborator |
---|---|
Dow University of Health Sciences |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changing perceptions regarding SLT and BQ use | modified Global Youth Tobacco Survey will be used to assess the perceptions of adolescents | 3 months | |
Secondary | prevalence of SLT and BQ use in 11-16-year-old | modified Global Youth Tobacco Survey will be used | 3 months | |
Secondary | Quit/quit attempts by the participants | modified Global Youth Tobacco Survey will be used | three months | |
Secondary | prevalence of OPMLs in the users of SLT and BQ | modified Global Youth Tobacco Survey will be used | three months | |
Secondary | perceptions regarding warning labels on SLT and BQ product pack | modified Global Youth Tobacco Survey will be used | three months |
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