Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000469213
Ethics application status
Approved
Date submitted
15/03/2017
Date registered
3/04/2018
Date last updated
11/03/2019
Date data sharing statement initially provided
11/03/2019
Type of registration
Prospectively registered

Titles & IDs
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
Secondary ID [1] 291398 0
NONE
Secondary ID [2] 293518 0
NIL
Universal Trial Number (UTN)
U1111-1194-0046
Trial acronym
GRITS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cigarette smoking 302415 0
nicotine addiction 302416 0
Condition category
Condition code
Mental Health 301985 301985 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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 Group Based Therapy for Smoking Cessation by Inspiring in New Zealand and has received accreditation. The researcher is responsible for the delivery of the behavioral intervention based on the GBT-MAL and prescription of the medication. Any issues related to medication will be highlighted to the researcher and will be addressed accordingly. Participants will have direct contact to the researcher for any assistance required during the trial through messaging, email or whatsapp.

Participants will be recruited from 3 centers in Malaysia (University of Malaya Medical Center , University of Malaya Student Health Center and Ministry of Health District Health Clinic). The total number of participants in this trial is 120. Total participants recruited in each centers is 40 in each centers. In each centers there will be 20 participants in the control arm (individual therapy) and 2 groups consisting of 10 participants in each group in the intervention arm (group therapy).

In the group therapy (intervention arm), there will be 10 participants in each group who will receive the behavioral intervention by the healthcare personnel in a group form.
In the individual therapy (control arm), each participant will receive the behavioral intervention by the healthcare personnel in a one-to-one session.

The total duration of the intervention is 7 weeks.The sessions will be held once a week for 7 weeks for both control arm (individual therapy) and the intervention arm (group therapy) Participants will undergo each session for 60 to 90 minutes depending on the objectives and its completion for each visit, During each week of the intervention, the GBT-MAL module has different sets of objectives which the healthcare provider will follow accordingly. After completing the 7 weekly sessions, participants will be followed up again at 3 months post quit date. Participants will be reminded on the appointment dates for the sessions and adherence to medication through personal messaging and texting from the researcher.
Intervention code [1] 297435 0
Treatment: Other
Intervention code [2] 300221 0
Treatment: Drugs
Comparator / control treatment
the control group is the intensive individual therapy for smoking cessation which is the standard care in Malaysia. In Malaysia, there are more than 500 health centers which provides smoking cessation services for patients who wants to quit smoking.
The quit smoking services is delivered by the doctors,dentist, pharmacist,nurses and assistant medical officers who have been trained to provide the services and the prescription of medication will be done by doctors and pharmacist. Currently, the mode of delivery of counselling is by one-to-one individual sessions.The quit rate among the patients attending the quit smoking clinic varies from 15-25%. . The medication provided at the quit smoking clinics are Nicotine Replacement Therapy or Varenicline.
Control group
Active

Outcomes
Primary outcome [1] 301406 0
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)
Timepoint [1] 301406 0
3 months after initiation of intervention (3 months post quit date)
Secondary outcome [1] 342744 0
Continuous abstinence- the proportion of patients who have stopped smoking, defined as self-reported completely stopped smoking at 1 week post quit date
Timepoint [1] 342744 0
One week post quit date
Secondary outcome [2] 342745 0
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.
Timepoint [2] 342745 0
One week post quit date
Secondary outcome [3] 342746 0
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)
Timepoint [3] 342746 0
One week post quit date
Secondary outcome [4] 342747 0
Changes in the physical signs and symptoms of nicotine withdrawal –measured using the Mood and Physical Symptoms Scale (MPSS) in abstinent smokers.
Timepoint [4] 342747 0
One week post quit date
Secondary outcome [5] 342748 0
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.
Timepoint [5] 342748 0
One week post quit date
Secondary outcome [6] 342749 0
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.
Timepoint [6] 342749 0
One week post quit date
Secondary outcome [7] 342750 0
Satisfaction towards group based therapy as a smoking cessation tool using the Client Satisfaction Questionnaire -8 (CSQ-8)
Timepoint [7] 342750 0
One week post quit date
Secondary outcome [8] 342751 0
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.
Timepoint [8] 342751 0
One month post quit date
Secondary outcome [9] 342752 0
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.
Timepoint [9] 342752 0
One month post quit date
Secondary outcome [10] 342753 0
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)
Timepoint [10] 342753 0
One month post quit date
Secondary outcome [11] 342754 0
Changes in the physical signs and symptoms of nicotine withdrawal –measured using the Mood and Physical Symptoms Scale (MPSS) in abstinent smokers.
Timepoint [11] 342754 0
One month post quit date
Secondary outcome [12] 342755 0
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.
Timepoint [12] 342755 0
One month post quit date
Secondary outcome [13] 342756 0
Side effects related to treatment –information regarding side effects and adverse effects related to treatment are collected at all time points.
Timepoint [13] 342756 0
One month post quit date
Secondary outcome [14] 342757 0
Satisfaction towards group based therapy as a smoking cessation tool using the Client Satisfaction Questionnaire -8 (CSQ-8)
Timepoint [14] 342757 0
One month post quit date
Secondary outcome [15] 342758 0
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
Timepoint [15] 342758 0
One month post quit date
Secondary outcome [16] 343596 0
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.
Timepoint [16] 343596 0
Three months post quit date
Secondary outcome [17] 343597 0
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)
Timepoint [17] 343597 0
Three months post quit date
Secondary outcome [18] 343598 0
Changes in the physical signs and symptoms of nicotine withdrawal –measured using the Mood and Physical Symptoms Scale (MPSS) in abstinent smokers
Timepoint [18] 343598 0
Three months post quit date
Secondary outcome [19] 343599 0
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.
Timepoint [19] 343599 0
Three months post quit date
Secondary outcome [20] 343600 0
Side effects related to treatment –information regarding side effects and adverse effects related to treatment are collected at all time points.
Timepoint [20] 343600 0
Three months post quit date
Secondary outcome [21] 343601 0
Satisfaction towards group based therapy as a smoking cessation tool using the Client Satisfaction Questionnaire -8 (CSQ-8)
Timepoint [21] 343601 0
Three months post quit date
Secondary outcome [22] 343602 0
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
Timepoint [22] 343602 0
Three months post quit date
Secondary outcome [23] 343603 0
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.
Timepoint [23] 343603 0
Three months post quit date

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants with polysubstance abuse, unable to read or understand English and Bahasa Malaysia will not be included

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computerized sequence generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
none
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A recruitment plan will be developed a good-sized group of participants for the Intensive Group Therapy (IGT) and the Intensive Individual Therapy (IIT) by utilizing in-campus campaign and mass media advertisement. The estimated attendance for the Intensive Group Therapy is 50% and 50% in the Intensive Individual Group. However, the number of participants will be higher in a more motivated group. Proactive recruitment by disseminating information face to face to potential participants, healthcare providers during clinics sessions and during community services. This is method will be suitable for participants who are ambivalent. Reactive recruitment will also be conducted by disseminating information which will make participants get in touch with the researcher or the healthcare provider. The information will be disseminated through Facebook, Instagram, twitter and newspaper articles.

Sample size to estimate a proportion with specified precision
Sample size is calculated using the formula:
n = (Z2 x P(1 - P))/e2
Where Z = value from standard normal distribution corresponding to desired confidence level (Z=1.96 for 95% CI)
P is expected true proportion
e is desired precision (half desired CI width).
For small populations (n) can be adjusted so that n(adj) = (Nxn)/(N+n)
Estimated Proportion: 0.28 (success rate in group intervention 28%)(Maria Ramos, Joana Ripol, 2010) . for continous variables, t-test will be used for normal distribution and mann-whitney U test for non normal distribution. for categorical data, chi-square test will be used.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/06/2019
Actual
Date of last participant enrolment
Anticipated
31/12/2019
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 8743 0
Malaysia
State/province [1] 8743 0
KUALA LUMPUR / PETALING JAYA

Funding & Sponsors
Funding source category [1] 295868 0
University
Name [1] 295868 0
UNIVERSITY OF MALAYA
Country [1] 295868 0
Malaysia
Primary sponsor type
University
Name
UNIVERSITY OF MALAYA
Address
Jalan Universiti, 50603 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 294730 0
None
Name [1] 294730 0
Address [1] 294730 0
Country [1] 294730 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299550 0
UMMC Medical Ethics Committee
Ethics committee address [1] 299550 0
Ethics committee country [1] 299550 0
Malaysia
Date submitted for ethics approval [1] 299550 0
30/10/2017
Approval date [1] 299550 0
16/03/2018
Ethics approval number [1] 299550 0
2017105-5640

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 73142 0
Dr RASHIDI MOHAMED B PAKRI MOHAMED
Address 73142 0
Department of Psychological Medicine
Faculty of Medicine
University of Malaya
Jalan Universiti,
50603 Kuala Lumpur,
Wilayah Persekutuan Kuala Lumpur,
Malaysia
Country 73142 0
Malaysia
Phone 73142 0
+603-7967 4623 / 4528 / 4404
Fax 73142 0
+603-7956 6634
Email 73142 0
[email protected]
Contact person for public queries
Name 73143 0
Rashidi Mohamed b Pakri Mohamed
Address 73143 0
Department of Psychological Medicine
Faculty of Medicine
University of Malaya
Poscode 59100
Federal Territory of Kuala Lumpur
Malaysia
Country 73143 0
Malaysia
Phone 73143 0
+6016-6682486
Fax 73143 0
Email 73143 0
[email protected]
Contact person for scientific queries
Name 73144 0
Rashidi Mohamed Pakri Mohamed
Address 73144 0
Department of Psychological Medicine
Faculty of Medicine
University of Malaya
Poscode 59100
Federal Territory of Kuala Lumpur
Malaysia
Country 73144 0
Malaysia
Phone 73144 0
+6016-6682486
Fax 73144 0
Email 73144 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
participants are patients who are followed up for smoking cessation and other medical conditions and individual participant data IPD will not be available due to patient confidentiality.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.