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

NCT05782166 | Unknown

• 1 other identifier: RSCH ID-23-00412-TVU
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Betel Quid; Cessation Program; Effectiveness

Outcome Measures

Primary Outcomes (2)

• Change in the number of participants who self-reported that they had quitted betel quid chewing behaviour from baseline at Day-22

  A follow-up questionnaire will be used to assess the self-reported cessation rate. This rate will represent the immediate cessation prevalence after the program

  Day-22

• Change in the number of participants who self-reported that they had quitted betel quid chewing behaviour from baseline at Month-3

  A follow-up questionnaire will be used to assess the self-reported cessation rate. This rate will represent the intermediate-term cessation prevalence of the program

  Month-3

Secondary Outcomes (2)

• Change in the levels of areca nut biomarkers in the saliva sample from baseline at Day-22

  Day-22

• Change in the levels of areca nut biomarkers in the saliva sample from baseline at Month-3

  Month-3

Study Arms (2)

Betel Quid Cessation via Educational Booklet

PLACEBO COMPARATOR

Participants will be given only an educational booklet on screening day (Day-1) and will be followed up on Day-22 and Month-3 to assess their current chewing status and other related parameters.

Behavioral: Betel Quid Educational Booklet

Betel Quid Cessation via Educational Booklet & Intervention Module

EXPERIMENTAL

Participants will undergo a 5-intervention sessions which will enhance their self-efficacy o quit their chewing behaviour. During the intervention sessions, they will be guided on how to monitor their chewing triggers, the lifestyle changes that they can potentially make, how to tap on their social support system to aid in their cessation efforts and others. The intervention will last for 22 days and a follow-up session will be made on Month-3.

Behavioral: Betel Quid Educational Booklet; Behavioral: Betel Quid Cessation Intervention Module

Interventions

Betel Quid Educational Booklet BEHAVIORAL

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.

Betel Quid Cessation via Educational Booklet; Betel Quid Cessation via Educational Booklet & Intervention Module

Betel Quid Cessation Intervention Module BEHAVIORAL

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.

Betel Quid Cessation via Educational Booklet & Intervention Module

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A self-reported betel quid chewer who has been practising chewing habit for the past 6 months with atleast 2-3 chewing episodes per week. The ingredient of betel quid must include areca nut without or without smokeless tobacco.
• Age of participant must be 18 years old and above
• Participants must be residing in study location (Kota Belud, Sabah)
• Ability to comprehend, converse and read in Bahasa Melayu and their local language (Bajau)
• Participants who are able to provide written consent and agree to comply with all protocol-specified procedures such as providing saliva samples, participating in five 1-2 hours sessions of intervention over 22 days and agree to attend follow-up session on the third month

You may not qualify if:

• Non-Malaysian citizen
• Participants who are not willing to quit the betel quid chewing habit at the time of the study
• Women chewers who are pregnant or nursing at the time of study
• Individuals with psychiatric illness or special social situations that would limit their compliance with study requirements

Sponsors & Collaborators

• University of Malaya: lead
• University of Hawaii Cancer Research Center: collaborator
• University of Guam: collaborator

Study Sites (1)

State Dental Health Department

Kota Kinabalu, Sabah, 88590, Malaysia

Location

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  BACKGROUND

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Jennifer Geraldine Doss, PhD

  Universiti Malaya

  STUDY CHAIR

• Amer Siddiq Amer Nordin, PhD

  Universiti Malaya

  STUDY DIRECTOR

• Mary Melissa Sarimuthu, MCOH

  Universiti Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mary Melissa Sarimuthu, MCOH

CONTACT

+60196525710; lissary04@gmail.com

Jennifer Geraldine Doss, PhD

CONTACT

+603-79672748; jendoss@um.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 12, 2023
• First Posted: March 23, 2023
• Study Start: January 2, 2024
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)