A Research Study on a Community-Based Stop Smoking Programme for Women

Participant Information Leaflet

A Research Study on a Community-Based Stop Smoking Programme for Women

You are being invited to take part in a research study Before you decide whether or not to take part in the research, it is important for you to understand why the research is being done and what it will involve. Please take your time to read the information in this leaflet before deciding. If you have any questions or do not understand the information, you can ask the research team.

The aim of this research is to compare a new ‘We can Quit’ programme to the standard HSE stop-smoking programme in different districts to see which one works best for women. The HSE supports both programmes.

We will give women from eight districts the opportunity to take part. Each district will be given one of the programmes to test. You will have an equal chance (1 in 2) of your district being given either the ‘We can Quit’ or the standard HSE programme. Your district cannot choose which one to test out. At the end of the study, everyone will be offered the chance to take part in the new ‘We can Quit’ programme.

The study is led by Professor Catherine Hayes, Principal Investigator, at Trinity College Dublin in partnership with the Irish Cancer Society, HSE staff and UK researchers. This study is funded by the Health Research Board Ireland.

We are looking for women aged 18 or over who smoke daily, but would like to try to stop smoking. If you live in one of the selected study districts you may be able to take part.

To get the most of the programme, it is important that you can understand and speak English. You must also be willing to stay in the programme and attend a follow-up appointment after 6 months. If you are pregnant now or become pregnant during the study, we cannot accept you into the research.

No, it is up to you to decide if you would like to take part or not. You do not have to do so. If you decide to take part, you will be asked to sign the consent form.

If you agree to take part, you are still free to leave the study at any time without explaining why. You may also refuse to answer any of the questions or opt out of part of the study if you choose. If you choose to leave the study, you will still be able to access standard stop-smoking programmes and your standard of care or legal rights will not be affected.

About 200 women across 8 districts will take part in the study. Your participation will be needed for the duration of the programme and for 6 months after finishing the programme so we can follow up with you.

If you decide to take part in the research, you will be asked to sign the consent form and then answer questions about yourself, your smoking and your general health and well-being. This should take approximately 20 minutes. You will then be assigned to the programme that has been chosen for your district and will be asked to attend for the duration of the programme. If you are part of the ‘We Can Quit programme’, you will be invited to attend weekly group sessions over 12 weeks. The group sessions will take place in your area, and each session will last about 1.5 hours.

If you are part of the standard programme, you will be invited to attend the HSE stop smoking programme which involves attending about seven individual sessions with a Stop Smoking Officer. The sessions will take place in your area, and each session will last about half an hour.

You will be asked to fill in a follow-up questionnaire at 3 months after the start of the programme. This will take 15 minutes at most. We will also ask you to fill in a questionnaire after 6 months which will take 10minutes at most. These questions will ask about the programme and your health and will be used to learn more about the programmes and measure the health benefits of stopping smoking. As part of the research, to measure whether or not the programmes have helped you to stop smoking, we will test saliva samples for signs of smoking. We will do this by collecting saliva samples at the end of the programme sessions and at 6-month follow up. These samples will be sent to a company (ABS Laboratories) in the UK. Your name or personal details will not appear on any of the samples that are sent for analysis.

To get a sense of your experience of the programme, we may ask participants who have received the ‘We can Quit’ programme to take part in a short interview with one of the research team at the end of the programme and at 6 months after the research is finished. This is optional and you will be asked to consent to this separately. This will help us to get a full picture of what the programme was like and how we may improve it in the future. We will record the interview with a voice recorder. The interview will be put into writing word for word without your name and the voice recording will then be destroyed. You may ask for the text of the interview if you wish. The interview will take no longer than one hour.

We are also interested in the effects on your health when you stop smoking. To measure this, we may ask you to do a simple breathing test at the start, middle and end of the programme. These tests only take a few minutes and there is no risk.

There are no major risks to taking part in this study. However, you may experience withdrawal symptoms, such as cravings, or minor side effects from Nicotine Replacement therapy. Your Programme Facilitator/ Stop Smoking Officer or pharmacist will provide you with a full list of these and advise you on how to deal with them.

If you succeed in stopping smoking, your health and wellbeing will improve. Your breathing may get better as well as your ability to exercise. You will be off cigarettes and may be better off financially. Your skin and hair may improve. You will lower your risk of heart disease, stroke and cancer and may increase your life expectancy. You will also help researchers and healthcare staff to learn how to best support and encourage women to quit smoking. This may help to shape stop smoking services for women in Ireland.

Any information that identifies you (such as name and address) will not be shared outside of the research team. We will keep all your information confidential. Your name will be replaced by a code and stored separately from your data. Only the researcher will hold the key to the code. Your data will not be used in future unconnected research without your consent. The company to which your saliva samples will be kept will destroy your saliva samples after analysis.

In keeping with national and Trinity College guidelines, we will keep your study data in a safe and secure place for 7years. Only the research team will have access to this. Your information will be destroyed securely after that time.

To make sure that the information collected during the study is correct and accurate and that the study was performed correctly, your records may be checked by the researchers, members of a Steering Committee or the Research Ethics Committee. They will keep your information confidential.

The study results will be used to guide researchers and clinical staff on how best to organise stop smoking services for women. The results of the study may be used for publication in a medical journal and for discussion at a health conference. You will not be identified in any presentation or publication.

You may be eligible for a €20 shopping voucher, if you complete follow-up questionnaires.

The study has been approved by the Research Ethics Committee of the School of Medicine at Trinity College Dublin. It is funded by the Irish Health Research Board.

If you would like to have more information about the study or if you have any questions, please call the Programme Manager at 01-231 6669 (email ) or Study Coordinator Aurelia Ciblis at 01-896 1385 (email ).

WCQ2 Participant Information Leaflet V9_08.01.18; 10/01/18; Aurelia Ciblis