Group Intervention for Tobacco Smoking Cessation (GRITS) Phase II: A Pragmatic Randomized Control Trial Comparing Group and Individual Therapy (Standard Care) to Assist Patients to Quit Smoking in Malaysia

• Register: ANZCTR
• Last refreshed on: 15 July 2019
• Main ID: ACTRN12618000469213
• Date of registration: 03/04/2018
• Prospective Registration: Yes
• Primary sponsor: UNIVERSITY OF MALAYA
• Public title: Group Intervention for Tobacco Smoking Cessation (GRITS) Phase II: A Pragmatic Randomized Control Trial Comparing Group and Individual Therapy (Standard Care) to Assist Patients to Quit Smoking in Malaysia
• Scientific title: Group Intervention for Tobacco Smoking Cessation (GRITS) Phase II: A Pragmatic Randomized Control Trial Comparing Group and Individual Therapy (Standard Care) to Assist Patients to Quit Smoking in Malaysia
• Date of first enrolment: 03/06/2019
• Target sample size: 120
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12618000469213.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy;
• Phase: Not Applicable

Countries of recruitment

Malaysia

Contacts

• Name: Dr Rashidi Mohamed b Pakri Mohamed

• Name: Dr Rashidi Mohamed Pakri Mohamed

Key inclusion & exclusion criteria

Inclusion criteria: Participants are active smokers. Active smokers are smokers who smoke one or more cigarettes in a week.Participants who are above the age of 18 years old, able to read and understand English and Bahasa Malaysia will be eligible for this study
Exclusion criteria: Participants with polysubstance abuse, unable to read or understand English and Bahasa Malaysia will not be included

Age minimum: 18 Years
Age maximum: No limit
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Mental Health - Addiction

cigarette smoking;nicotine addiction;
cigarette smoking
nicotine addiction

Intervention(s)

This trial is named GRITS which is an acronym for Group vs Individual Intervention for Tobacco Smoking Cessation. This trial is designed to determine the effects of smoking cessation programmes delivered in a group format and to compare the effectiveness of group therapy with the standard care in Malaysia which is the individual therapy.The objectives are to determine whether if the group based therapy is at least as effective as the individual therapy in assisting participants to quit smoking, to determine whether the group based therapy plus pharmacotherapy is as effective as individual therapy in reducing the severity of the withdrawal symptoms, to determine whether the group based therapy is an acceptable method for smoking cessation and to determine whether the group based therapy is at least as cost effective as the individual therapy (Standard Care).

Both arm (individual and group) will receive medication (pharmacotherapy). The medication is the standard treatment which has been approved by the Ministry of Health in Malaysia and is being provided in all hospitals and district health clinic. for patients attending quit smoking clinics. The medications are Nicotine Replacement Therapy (gum, lozanges and patch) and Varenicline.

Both arm (individual and group) of the trial will receive the same behavioral intervention. The behavioral intervention includes motivation to quit smoking, explanation on health dangers related to smoking and benefits of quitting, preparing for quit date, counselling on identifying cues and craving and how to overcome those situations and how to prevent relapse. The behavioral intervention is based on the module adapted from the New Zealand Group Based Therapy for Smoking Cessation which has undergone cultural and linguistic adaptation for Malaysian population. The final version of the module is called GBT-MAL (Group Based Therapy -Malaysian version).

The researcher / PI has undergone training for the New Zealand

Primary Outcome(s)

7 day point prevalence for abstinence at 12 weeks post quit date as primary endpoint and at each follow up for continuous abstinence. Continuous abstinence- the proportion of patients who have stopped smoking, defined as self-reported completely stopped smoking at 1 week post quit date and smoking not more than 5 cigarettes in the three months after the quit date. Abstinence is determined by self reported and validated by Carbon Monoxide Smojerlyzer of less than 10p.p.m (russell's standard) [3 months after initiation of intervention (3 months post quit date)]

Secondary Outcome(s)

Side effects related to treatment –information regarding side effects and adverse effects related to treatment are collected at all time points.[One month post quit date]

Current smoking details (number of cigarettes smoked per day)-for patients who are smoking during follow-up, the following outcomes will be assessed which includes number of cigarettes smoked per day, proportion of patients who have significantly reduced the number of cigarettes smoked per day (at least 25% reduced from the previous smoking habit), smoking satisfaction with MCEQ (Modified Cigarette Evaluation Questionnaire)[One month post quit date]

Side effects related to treatment –information regarding side effects and adverse effects related to treatment are collected at all time points.[Three months post quit date]

Seven-day point prevalence- the proportion of patients that have stopped smoking, defined as self-reported having not smoked a single cigarette (not a single puff) in the past 7 days.
[One week post quit date]

Continuous abstinence- the proportion of patients who have stopped smoking, defined as self-reported completely stopped smoking at 1 week post quit date
[One week post quit date]

Information related to pharmacotherapy –All patients will be asked regarding their treatment (NRT or Champix) which includes types, dosage, frequency of use at all time points.
[One week post quit date]

Information related to pharmacotherapy –All patients will be asked regarding their treatment (NRT or Champix) which includes types, dosage, frequency of use at all time points.[Three months post quit date]

Current smoking details (number of cigarettes smoked per day)-for patients who are smoking during follow-up, the following outcomes will be assessed which includes number of cigarettes smoked per day, proportion of patients who have significantly reduced the number of cigarettes smoked per day (at least 25% reduced from the previous smoking habit), smoking satisfaction by MCEQ (Modified Cigarette Evaluation Questionnaire)[One week post quit date]

Side effects related to treatment –information regarding side effects and adverse effects related to treatment are collected at all time points. The side effects related to Nicotine Replacement therapy include nausea , vomiting , headache,dizziness, sore throat, jaw discomfort (for nicotine gum) , skin allergies (for nicotine patch), The side effects related to Varenicline include sleep disturbance, mood changes, nausea,vomiting,dry mouth, abdominal discomfort.[One week post quit date]

Satisfaction towards group based therapy as a smoking cessation tool using the Client Satisfaction Questionnaire -8 (CSQ-8)
[One week post quit date]

Seven-day point prevalence- the proportion of patients that have stopped smoking, defined as self-reported having not smoked a single cigarette (not a single puff) in the past 7 days.[Three months post quit date]

Current smoking details (number of cigarettes smoked per day)-for patients who are smoking during follow-up, the following outcomes will be assessed which includes number of cigarettes smoked per day, proportion of patients who have significantly reduced the number of cigarettes smoked per day (at least 25% reduced from the previous smoking habit), smoking satisfaction with MCEQ (Modified Cigarette Evaluation Questionnaire)[Three months post quit date]

Changes in the physical signs and symptoms of nicotine withdrawal –measured using the Mood and Physical Symptoms Scale (MPSS) in abstinent smokers.
[One week post quit date]

Continuous abstinence- the proportion of patients who have stopped smoking, defined as self-reported completely stopped smoking at 1 week post quit date and smoking not more than 5 cigarettes in the one month after the quit date.[One month post quit date]

Satisfaction towards group based therapy as a smoking cessation tool using the Client Satisfaction Questionnaire -8 (CSQ-8)[Three months post quit date]

EuroQol 5D 5L and Cost information- cost outcomes will be derived from known cost of various products includes cost per quitter and cost per patient reducing their daily cigarette consumption (Incremental Cost Effectiveness Ratio ICER). The tobacco expenditure savings to individual smokers will also be calculated using the data on the daily amount smoked prior to quitting and the price of product smoked. The association between the economic value of quitting with the health-related quality of life questionnaire will be done
[One month post quit date]

EuroQol 5D 5L and Cost information- cost outcomes will be derived from known cost of various products includes cost per quitter and cost per patient reducing their daily cigarette consumption (Incremental Cost Effectiveness Ratio ICER). The tobacco expenditure savings to individual smokers will also be calculated using the data on the daily amount smoked prior to quitting and the price of product smoked. The association between the economic value of quitting with the health-related quality of life questionnaire will be done[Three months post quit date]

Satisfaction towards group based therapy as a smoking cessation tool using the Client Satisfaction Questionnaire -8 (CSQ-8)[One month post quit date]

Information related to pharmacotherapy –All patients will be asked regarding their treatment (NRT or Champix) which includes types, dosage, frequency of use at all time points.[One month post quit date]

Seven-day point prevalence- the proportion of patients that have stopped smoking, defined as self-reported having not smoked a single cigarette (not a single puff) in the past 7 days. [One month post quit date]

Changes in the physical signs and symptoms of nicotine withdrawal –measured using the Mood and Physical Symptoms Scale (MPSS) in abstinent smokers.[One month post quit date]

Changes in the physical signs and symptoms of nicotine withdrawal –measured using the Mood and Physical Symptoms Scale (MPSS) in abstinent smokers[Three months post quit date]

Seven-day point prevalence- the proportion of patients that have stopped smoking, defined as self-reported having not smoked a single cigarette (not a single puff) in the past 7 days. [Three months post quit date]

Secondary ID(s)

NIL

NONE

Source(s) of Monetary Support

UNIVERSITY OF MALAYA

Ethics review

Status: Approved
Approval date:
Contact:

UMMC Medical Ethics Committee