Adapting a Betel Quid Cessation Program for a High-risk Community in Malaysia and Evaluating Its Effectiveness

NCT05782166 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2023-12-06

No results posted yet for this study

Summary

The practice of betel quid chewing is known as the top 3 causes of oral cancers in Malaysia. The devastating part among Malaysians are that more than 50% of these cancer patients present at a later stage of this disease necessitating a massive surgical procedure and a costly oncological treatment to remove the tumour and restore the vital structures in the head and neck regions of the patients. In 2010, World Health Organisation recognised that the users of betel quid are having a 'Dependency Syndrome' similar to that of a cigarette smoking. Since then, much research has been focussed upon the 'addictive nature' and the cessation of this ill-health behaviour.

Malaysia's current plight is its strikingly high prevalence of betel quid users within its high-risk communities. The other challenge is the widely scattered high-risk communities across the diverse geography, locality, ethnicity, culture and native languages across the country that make cessation not an easy task but an uphill battle.

The latest available report in 2011 showed that the females in Sabah and Sarawak's indigenous communities presented with a prevalence of 28.4% being current chewers. This prevalence was way greater than the global prevalence of 10-20% of betel quid chewers reported worldwide. The female predominance among the betel quid users in Malaysia is another matter of concern as studies had claimed that females are less likely to cease chewing habit compared to their male counterparts.

Fortunately, in 2015, a feasibility study was conducted to adapt an intensive smoking cessation intervention to cater for betel quid chewers which received a high cessation rate of 65%. Later in 2018, researchers incorporated a saliva test to assess the effectiveness of a group-based intensive betel quid cessation program which also yielded a high cessation rate of 38% among the participants.

Since there is no existing betel quid cessation intervention in Malaysia, this study aims to adapt a betel quid cessation program for a high-risk community in Malaysia.

This study hypothesised that the intervention group will produce a significantly greater cessation rate compared to the control group at the 3-months follow-up assessment.

Conditions

  • Betel Nut Chewer
  • Tobacco Cessation

Interventions

BEHAVIORAL

Betel Quid Educational Booklet

Eligible and consented participants will be interviewed for baseline questionnaire completion. Details regarding participants' demographics, betel quid chewing behaviours, betel quid composition, betel quid dependency levels, reasons for chewing, readiness and self-perceived barriers to quit will be obtained. Saliva samples will be obtained. Participants will be given an educational booklet containing general information regarding betel quid and areca nut, risk associated with betel quid chewing behaviour, cessation strategies that are modeled after tobacco cessation and some relevant researcher's contact details. Participants will be followed up at Day-22 and Month-3 for information regarding compliance, current chewing status, number of habit cut-down (quid/day), total number of sessions attended and current betel quid composition. Saliva samples will be taken during follow-ups for the cessation verification of participant's chewing behaviour.

BEHAVIORAL

Betel Quid Cessation Intervention Module

All eligible and consented participants will be interviewed for baseline questionnaire completion. Details regarding participants' demographics, betel quid chewing behaviours, betel quid composition, betel quid dependency levels, reasons for chewing, readiness and self-perceived barriers to quit will be obtained. Saliva samples will be obtained. An interactive, educational talk will be given regarding the content of the educational booklet. Participants will undergo a 5-intervention sessions cessation program (M-BENIT) and will be given topical worksheets on every session to monitor their triggers, lifestyle changes, social support system and others. Participants will be followed up at Day-22 and Month-3 for information regarding compliance, current chewing status, number of habit cut-down (quid/day), total number of sessions attended and current betel quid composition. Saliva samples will be taken during follow-ups for the cessation verification of participant's chewing behaviour.

Sponsors & Collaborators

  • University of Hawaii Cancer Research Center

    collaborator OTHER
  • University of Guam

    collaborator OTHER
  • University of Malaya

    lead OTHER

Principal Investigators

  • Jennifer Geraldine Doss, PhD · Universiti Malaya

  • Amer Siddiq Amer Nordin, PhD · Universiti Malaya

  • Mary Melissa Sarimuthu, MCOH · Universiti Malaya

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-02
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05782166 on ClinicalTrials.gov