This page describes the Prevention of Shoulder Problems Trial (PROSPER). The trial has now finished. If you took part in PROSPER, this page describes how your data were used and are being stored.

The Prevention of Shoulder Problems Trial (PROSPER) study was managed by the Warwick Clinical Trials Unit and was led by Professor Julie Bruce. The study was paid for by the NHS because breast cancer treatments can affect the shoulder and upper body.

This page describes how the study team access and use your personal data. We refer to this as a "privacy notice" because it explains how we will use and look after your personal data.

Who will have access to my data?

The PROSPER study team at the University of Warwick Clinical Trials Unit will have access to your data. The study team will analyse the data we collected to generate the results of the PROSPER trial. The University of Warwick Clinical Trials Unit is referred to as the "Data Controller" which means they have overall responsibility for looking after your data.

The personal data we hold, with your consent, include your name, address, NHS number, date of birth and postcode. We also hold clinical information on type of operation and other treatments you had. We collected health data which is considered to be ‘special category personal data’.

When you agree to take part in a research study, the information about your health and care may be provided to researchers running other research studies in this organisation and in other organisations. These organisations may be universities, NHS organisations or companies involved in health and care research in this country or abroad. Your information will only be used by organisations and researchers to conduct research in accordance with the UK Policy Framework for Health and Social Care Research. Your information could be used for research in any aspect of health or care, and could be combined with information about you from other sources held by researchers, the NHS or government.

Where this information could identify you, the information will be held securely with strict arrangements about who can access the information. The information will only be used for the purpose of health and care research, or to contact you about future opportunities to participate in research. It will not be used to make decisions about future services available to you, such as insurance.

Where there is a risk that you can be identified your data will only be used in research that has been independently reviewed by an ethics committee.

Consent for access to my personal data

Everyone that took part in the PROSPER trial was asked to sign a Consent Form. As a reminder, you provided signed, written consent at the start of the study for your contact details to be held at Warwick Clinical Trials Unit. This meant that the study team could send questionnaires and other study-related documents to you. You signed consent giving permission for the trial team to access your medical records. We have accessed your data via NHS Digital who look after health and care information. You consented to your health and care data being accessed.

Who are NHS Digital?

NHS Digital is an organisation that collects health and care data from NHS hospitals in England and Wales. Examples of the type of health data that they hold includes hospital admissions, operations, accident and emergency attendances and other health care information.

Why did we need your personal data from NHS Digital?

We wanted to know whether you have had any hospital attendances or admissions, to find out if you have been treated before and during the PROSPER study period. Although we asked everyone taking part in the study about how many hospital appointments they had (in your follow-up questionnaires), this can be difficult for some people to keep track of and remember. The study team accessed data from NHS Digital to provide us with accurate numbers of hospital admissions and appointments over the study period. This was to help us work out which of the treatments were best for preventing shoulder problems after breast cancer surgery over 12-months. We found that although physiotherapy-led exercise was more costly in the short term, it worked out to be cheaper over the longer term as those who did the exercise programme had fewer appointments and hospital admissions.

How did we access your data from NHS Digital?

We applied to NHS Digital for access to your health data. We provided NHS Digital with your NHS number, date of birth and postcode to allow linkage to the data held by NHS Digital. This linked data was transferred back to the University of Warwick Clinical Trials Unit using a secure, encrypted procedure. Only a few selected, named members within the PROSPER study team had access to this health data.

Will my participation in the trial be kept confidential?

We would like to reassure you that all personal data has been handled as you would expect and has been kept strictly confidential at all times and in compliance with the UK GDPR.

Will my data be shared with anyone?

We will not share your data with any third party outside of the PROSPER study team, other than for the purposes of linking to NHS Digital. Information that could identify you by name was only used to post out documents to you. We had planned a patient feedback event, arranged for March 2020 but this was postponed due to Covid-19. We have held your details to allow a patient feedback event in the future. We used a study number on all questionnaires so that your name and personal details did not appear anywhere other than on the restricted database held by the study team. Access to this database was restricted and password protected.

Can I opt out of the PROSPER Study?

It is not possible to opt out of the PROSPER study now it has been completed. The data have been reported in medical journals. All results were reported as ‘aggregate’ (summary) values and it is not possible to identify anyone who took part in the trial.

Please do not hesitate to contact us if you have any questions or queries about your participation in the trial. Please call 024 765 74656.

How long will my data be kept for?

Your data will be safely archived for at least 10 years beyond the end of the trial. This is a requirement of the University of Warwick Clinical Trials Unit which adheres to UK regulatory requirements for clinical trials.

What is the “legal basis” for you holding and processing my data?

Under the UK General Data Protection Regulation (UK GDPR), the lawful bases we rely on for processing your data are:

• article 6(1)(e) - processing is necessary for the performance of a task in the public interest and
• Article 9(2)(j) processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes

This allows us to process your personal data. If you would like more information about the lawful basis for processing your data, please visit the Information Commission’s Office (ICO) website: https://ico.org.uk/global/privacy-notice/make-an-enquiry.

Please note that the study team do not undertake any automated decision-making or profiling, based on the trial data we hold.

What are my rights?

As an individual taking part in a research study, you have the right to query any issue in relation use of your personal data. In the first instance, you can contact our Data Protection Officer at the University of Warwick who can help resolve any query, concern or complaint you raise. Contact details can be found on the link below.

https://warwick.ac.uk/services/legalandcomplianceservices/dataprotection/privacynotices/research/

How can I lodge a complaint?

If you are concerned or unhappy with any aspect of your involvement in the PROSPER study, you have the right to lodge a complaint with the ICO.

You can register a complaint on the ICO website (https://ico.org.uk/make-a-complaint) or you can ring the ICO helpline on 0303 123 1113 between Monday and Friday, 9am to 5pm.

When will the trial results be ready?

The PROSPER study is now finished. We have reported the findings. Please see the links below which will take you to the full trial results which were published in the British Medical Journal in November 2021. There is also a link to the funder report. The study was funded by National Institute for Health Research. The findings will also be presented to doctors, nurses and other health and social care professionals in the UK.

We would like to thank you again for taking part in the PROSPER Study.

The information that you have provided has been invaluable in helping us work out the best way to prevent shoulder problems for patients having breast cancer surgery. We know that it is safe to prescribe these exercises in the week after breast cancer surgery and if the PROSPER programme is followed as prescribed, this can reduce the risk of shoulder problems, reduce pain and improve physical health after your cancer treatment.

Link to main publication in British Medical Journal: Exercise versus usual care after non-reconstructive breast cancer surgery (UK PROSPER): multicentre randomised controlled trial and economic evaluation | The BMJ

Link to funder report: Exercise to prevent shoulder conditions in patients undergoing breast cancer treatment. The PRevention Of Shoulder Problems Study (PROSPER) (nihr.ac.uk)

 

Last updated: 10 May 2022