None listed
Conditions
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.
Interventions
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 man
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.
Sponsors
Royal Brisbane and Women's Hospital (RBWH)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed