Participant Information

IBIS-I: The Interventional Breast Cancer Intervention Studies 1

Results from the IBIS-I trial, which investigated tamoxifen to prevent breast cancer, showed that the incidence of breast cancer was reduced by 32% in women receiving tamoxifen compared to those taking placebo (dummy medication). Very importantly, these benefits extended beyond the treatment period, whilst most of the side effects did not. Recruitment to IBIS-I ended in March 2001 and overall 7154 women were recruited from 36 centres in 9 countries. In 2008 IBIS-I was converted to an epidemiological cohort study that aims to collect further information on the effectiveness and safety of tamoxifen via long-term follow-up until 2026. The long-term follow-up has minimal participant involvement and takes the form of annual questionnaires distributed from the Central Coordinating Office at the Centre for Cancer Prevention (based at Queen Mary University of London) and provision of data by NHS/public bodies (in the UK only). Participants in IBIS-I have consented to the post-treatment follow-up phase of the trial and can withdraw their consent at any time if they change their minds.Existing public bodies (NHS digital https://digital.nhs.uk/) are providing data to the IBIS-I central coordinating team and Queen Mary University of London (QMUL) will be responsible for the collection storage and processing of these data for the study. These data include:

  1. Cancer incidence (any diagnosis of cancer and the type of cancer it is)
  2. Mortality Data (in the event of death we will receive information confirming the date and cause of death)
  3. Hospital Episode Statistics (HES) which utilises your in-patient, out-patient and A&E data (to look for other significant clinical events of interest to the clinical trial e.g. serious fractures, heart attacks). 
  4. Current GP details so that we may request further follow up information about an event as identified in points 1-3.

These data will help assess the effectiveness of the trials’ interventions. As part of taking part in the trial, you will have provided your NHS number, name, date of birth and post code to allow us to request this information from the NHS/public bodies. The level of data collected from NHS digital will only be identifiable to us at QMUL and will not be shared with any third parties. Only authorised staff at the IBIS-I Coordinating Centre are able to access the data and only for specific purposes related to the trial. The data is stored in a secure, restricted-access environment.

You are free to withdraw at any time from the study or long term follow up aspects of the trials. This will in no way effect the level of care you receive. However if you decide that we may have no further information from you for the study, it will not be possible to remove your data from analyses that has already been done.Please contact the IBIS-I Central Coordinating Office for more detail on how to withdraw from further data collection as part of the IBIS-I trial, by calling 020 7882 5973, e-mailing ibis@qmul.ac.uk or completing this form.

IBIS-II: The Interventional Breast Cancer Intervention Studies 2

The “post-treatment follow-up phase” of the IBIS-II trial (that is after you have stopped taking your tablets) is vitally important in learning more about long-term safety and efficacy of anastrozole and tamoxifen. This includes following-up with anyone who decided to stop taking their medication before the full five year period. It will help us to find out more about the long-term benefits and side effects, which will provide women in the future with more understanding about choosing the best treatment.Participants in IBIS-II do not need to attend clinic for follow-up visits in the post-treatment phase of the trial as follow-up can be done by telephone from local sites or by postal questionnaire.All IBIS-II participants are encouraged to maintain contact with their trial nurse and inform them of any change to contact details as well as any significant health events. In the UK, NHS/public bodies are being used to supplement and/or confirm events reported by IBIS-II trial sites. Existing bodies (NHS digital https://digital.nhs.uk/) are providing data and Queen Mary University of London will be responsible for the collection storage and processing of this data for the study. This data will include:

  1. Cancer incidence (any diagnosis of cancer and the type of cancers)
  2. Mortality Data (in the event of death we will be receiving information confirming the date and cause of death)
  3. Hospital Episode Statistics (HES) which utilises your in-patient, out-patient and A&E data (to look for other significant clinical events of interest to the clinical trial e.g. serious fractures, heart attacks).
  4. Current GP details so that we may request further follow up information about an event as identified in points 1-3.

These data will help assess the effectiveness of the trials’ interventions. As part of taking part in the trial, you will have provided your NHS number, name, date of birth and post code to allow us to request this information from the NHS/public bodies.  The level of data collected from NHS digital will only be identifiable to us at QMUL and will not be shared with any third parties.

You are free to withdraw at any time from the study or long term follow up aspects of the trials. This will in no way effect the level of care you receive. However if you decide that we may have no further information from you for the study, it will not be possible to remove your data from analyses that has already been done.Please contact your local IBIS-II trial nurse for further details on how to withdraw from the IBIS-II trial.  Alternatively, you can request to withdraw from post-treatment follow-up questionnaires or further data collection by calling the IBIS-II Coordinating Centre on 020 7882 3838, e-mailing ibis@qmul.ac.uk or completing this form.