None listed
Conditions
Brief summary
This purpose of this study is to assess the effectiveness of using Quitline as a referral pathway into lung cancer screening, and to assess whether combining Nicotine Replacement Therapy and Quitline telephone counselling interventions in current smokers is effective for people at risk of lung cancer. Who is it for? You may be eligible for this trial if you are aged between 50 – 80 years old, have a Prostate Lung Colorectal Ovarian model 2012 (PLCOm2012) score of >=1.51% and are a person who currently smokes with a 20-pack year smoking history. The PLCOm2012 model has been developed for lung cancer detection, and a score of >=1.51% means you are eligible for lung cancer screening. Study details Participants will be randomly allocated by chance (similar to flipping a coin) to the intervention group or the control group. Participants allocated to the intervention will be receive Nicotine Replacement Therapy and Quitline telephone counselling interventions for 12 months. While those participants who are randomised into the control group will Nicotine Replacement Therapy and Quitline telephone counselling interventions for 12 weeks (3 months). Participants who are eligible for lung cancer screening (based on certain criteria [PLCOm2012 > 1.5%, Have a > 20 pack year smoking history), will have a free CT scan of the lungs (within 12 months of enrolment in the study). Questionnaires will be collected every three months for the first year to assess the acceptability of the intervention and then once a year for 4 years to assess patient reported outcomes. It is hoped this intervention will help design a national Australian Lung Cancer Screening Program.
Interventions
Participants will receive a scheduled four 1:1 Quitline counselling sessions via telephone, with extra calls as requested by the client, for 12 weeks post the initial contact with Quitline. Call duration ranges from 10 to 30 minutes sessions, dependent on client need. Follow up SMS invites to engage with the Quitline service will be scheduled at 10-week intervals up to 40 weeks post initial contact. Participants will be able to engage with the Quitline service as much as they wish to over the
Participants will receive a scheduled four 1:1 Quitline counselling sessions via telephone, with extra calls as requested by the client, for 12 weeks post the initial contact with Quitline. Call duration ranges from 10 to 30 minutes sessions, dependent on client need. Follow up SMS invites to engage with the Quitline service will be scheduled at 10-week intervals up to 40 weeks post initial contact. Participants will be able to engage with the Quitline service as much as they wish to over the 12 months period of the study. Participants will be provided with combined nicotine replacement therapy (NRT) for up to 12 weeks. Following the initial 12 weeks, participants will be eligible for further NRT at their request, for a further 40 weeks post initial intervention. NRT products comprise 21mg NRT patch, 4mg NRT gum, 4mg NRT lozenge and NRT Quick mist spray and are supplied alone or in combination based on the individual requirements of each client following discussion with a counsellor. NRT will distribute to the participant via Australia Post. Use of and response to NRT including adverse reactions will be captured by Quitline counsellors in the counselling sessions. Participants will also provide information on the NRT used in the research questionnaires. As this is a pragmatic study, the Low dose CT scan of the chest will be scheduled by the Radiology provider and the participants at a time of the participants choosing. The request form for the CT scan will be provided to the Radiology provider once enrolled. The CT scan must be undertaken within 12 months of enrolment.
Sponsors
The University of Queensland
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Persons invited by Quitline who currently smoke, 2. Aged 50 – 80 3. Have a PLCOm2012 score of >=1.51% 4. 20 pack year smoking history 5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1 6. Ability to provide own consent
Exclusion criteria
1. Clinical symptoms suspicious for lung cancer e.g. haemoptysis within the past 6 months, chest pain, unexplained weight loss within the past 6 months 2. Previous diagnosis of lung cancer within the past 5 years 3. On active treatment or follow up for any type of cancer outside the lung. 5. Pregnancy 6. Pneumonia or bronchitis requiring antibiotic treatment within the last 12 weeks 7. Unwilling to have a chest CT 8. Chest CT within the past 2 years 10. Cannot lie on CT scanning table on the back with arms over the head 11. Received chemotherapy or cytotoxic drugs within the last 6 months 12. Unwilling to sign a consent
Outcome results
None listed