Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000346976
Ethics application status
Approved
Date submitted
19/01/2011
Date registered
4/04/2011
Date last updated
4/04/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised controlled trial to evaluate the effectiveness of a smoking cessation intervention for people with chronic hepatitis C
Scientific title
A randomised controlled trial to evaluate the effectiveness of a smoking cessation intervention (Quitline and Nicotine Replacement Therapy) versus Quitline Intervention only for people with chronic hepatitis C to stop or reduce smoking in this group.
Secondary ID [1] 252413 0
Nil
Universal Trial Number (UTN)
Trial acronym
Quit Time
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nicotine dependence 257921 0
Depression 257922 0
Anxiety 257923 0
Stress 257924 0
Condition category
Condition code
Mental Health 258095 258095 0 0
Addiction
Public Health 265653 265653 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group receives a one off Quitline telephone counselling intervention (using behavioural techniques) and the provision of Nicotine replacement therapy (NRT) for a period of 8 weeks and the control group receive a one off Quitline counselling intervention only. The duration of the Quitline intervention varies from person to person. The NRT (patches) dose will vary according to the needs of the participants as assessed by the Nurse Practitioner . The needs will depend upon how many cigarettes the patients smoke per day. Those smoking > 15 cigarettes will receive 21 mg for 4 weeks then 14 mg for 2 weeks and 7 mgs for 2 weeks. Gum will also be given to the intervention group and again will be given to the participants according to their needs. Those smoking >15 cigarettes per day will receive 4mg gum and those smoking <15 will receive 2mg /day.
Intervention code [1] 256979 0
Treatment: Drugs
Intervention code [2] 256980 0
Behaviour
Comparator / control treatment
Quitline telephone counselling
Control group
Active

Outcomes
Primary outcome [1] 258955 0
Compliance with Smoking Cessation/reduction as measured by a self report smoking diary and Fagerstrom Tolerance Questionnaire
Timepoint [1] 258955 0
This Time 1: baseline prior to randomisation
Time 2: after 6 weeks
Time 3: after 12 weeks
Secondary outcome [1] 265122 0
Reduced Nicotine addiction measured by Fagerstrom Test for NicotineDependence
Timepoint [1] 265122 0
Time 1: baseline prior to randomisation
Time 2: after 6 weeks
Time 3: after 12 weeks
Secondary outcome [2] 265123 0
Change in levels of Depression, Anxiety and Stress as measured by Depression, Anxiety and Stress Scale (DASS 21)
Timepoint [2] 265123 0
Time 1: baseline prior to randomisation
Time 2: after 6 weeks
Time 3: after 12 weeks
Secondary outcome [3] 265124 0
Quality of Life as measured by WHOQOLBREF (Quality of Life questionnaire),
Timepoint [3] 265124 0
Time 1: baseline prior to randomisation
Time 2: after 6 weeks
Time 3: after 12 weeks

Eligibility
Key inclusion criteria
The study will include people who visit the hepatology outpatient’s clinics RBWH, for management of chronic hepatitis-C disease.

Inclusion Criteria
adults over the age of 18 years
who smoke cigarettes
who attend the hepatology outpatients clinics at the Royal Brisbane & Women's Hospital for the management of chronic hepatitis-C.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. People who are currently undergoing interferon based treatment will be excluded from the study as symptoms from treatment may confound the health outcomes being measured in the project.
2. People who are currently undergoing a smoking cessation programme will be excluded
3.Occassional smokers are excluded as it is not recommended they use nicotine replacement therapy.

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)
The Nurse practitioner will recruit potential participants for the study. The participants will be given an information and consent form and after signing the consent form they will be randomised using random numbers sequence and stratified according to number of cigarettes smoked eg >15 per day and <15 per day. The chief investigator is responsible forthe randomisation and stratification. This person is not associated with either the patients or the data collection and data input process.


Only the chief researcher (not associated with the patients will be responsible for the randomisation and allocation of participants. The participants and the nurse practitioner responsible for the Quitline referral and giving of Nicotine replacement therapy will be aware of who is in the treatment group. The research assistant responsible for data collection and who will give and take the questionnaires will not be aware of the allocation to intervention or control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random digits were generated using a randomisation table from a statistics book. A person (statistician) not involved with the study generated the numbers. Seperate numbers were generated for lighter smokers < 15 cigarettes per day and heavier smokers >15 cigarettes per day.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
132
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257433 0
Government body
Name [1] 257433 0
Queensland Health Nursing & Midwifery Research grants
Country [1] 257433 0
Australia
Funding source category [2] 257434 0
Government body
Name [2] 257434 0
Queensland Health Office of Health and Medical Research grants
Country [2] 257434 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Women's Hospital (RBWH)
Address
Butterfield St Herston, Brisbane, QLD 4029.
Country
Australia
Secondary sponsor category [1] 256663 0
None
Name [1] 256663 0
Address [1] 256663 0
Country [1] 256663 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259453 0
RBWH HREC
Ethics committee address [1] 259453 0
Royal Brisbane and Women's Hospital, Butterfield St Herston Brisbane, Qld, 4029
Ethics committee country [1] 259453 0
Australia
Date submitted for ethics approval [1] 259453 0
10/05/2010
Approval date [1] 259453 0
25/06/2010
Ethics approval number [1] 259453 0
AU/2/FE76011

Summary
Brief summary
The majority of smokers want to quit and support and advice from registered nurses has been proven effective (Rice et al., 2008) . Current literature reports that smokers with chronic hepatitis C have a higher risk of having poor health outcomes such as developing Hepatocellular Carcinoma (HCC) and they may also be at higher risk of having a lowered immune response . It is therefore recommended they should be advised to stop smoking before commencing on interferon based treatment (El-Zayadi 2004). This study aims to identify the effectiveness of evidence based smoking interventions (Quitline counselling intervention and Nicotine Replacement Therapy) which may have an impact on helping smokers quit and which may improve health outcomes for people who attend the RBWH for management of their chronic hepatitis C. This will be undertaken by conducting a randomised controlled trial of this high risk group of people. The results will inform the Nurse Practitioner for Hepatology, health services and policy makers of interventions which can be used to help smokers in this high risk group quit or reduce the amount of cigarettes they smoke and hence assist with better treatment outcomes for people with chronic hepatitis C.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31499 0
Address 31499 0
Country 31499 0
Phone 31499 0
Fax 31499 0
Email 31499 0
Contact person for public queries
Name 14746 0
Carol Reid
Address 14746 0
Royal Brisbane and Women's Hospital, Butterfield St Herston 4029 Brisbane, Queensland
Country 14746 0
Australia
Phone 14746 0
+61 7 36362653
Fax 14746 0
Email 14746 0
Carol_L_Reid@health.qld.gov.au
Contact person for scientific queries
Name 5674 0
Carol Reid
Address 5674 0
Royal Brisbane and Women's Hospital, Butterfield St Herston 4029 Brisbane, QLD.
Country 5674 0
Australia
Phone 5674 0
+61 7 36362653
Fax 5674 0
Email 5674 0
Carol_L_Reid@health.qld.gov.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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