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Introduction
ASCOT is a lifestyle trial for people diagnosed with cancer. This study is concerned with promoting a healthy lifestyle (diet, exercise etc) among people who have been diagnosed with breast, prostate or colorectal cancer. We have developed a lifestyle programme (consisting of a booklet and a phone call to talk more about the booklet) and are interested in finding out what patients think about it. We hope that this will enable us to improve the care of people who have been diagnosed with breast, prostate or colorectal cancer.
It is important that participants in this study are aware of what data we collect and how this is processed. In ASCOT we hold both personal data and special category personal data. The information provided here covers the detail of the data we hold for this study. For more general information on how research is conducted at UCL, including our legal basis for processing this data, please see:
https://www.ucl.ac.uk/legal-services/privacy/participants-health-and-care-research-privacy-notice
The data we process
We collect data in four ways:
- Questionnaires
- Pedometers that participants wear and then return to us
- Dietary recalls (24 hour) which are completed online or over the phone
- Qualitative interviews (with a small number of participants at 3-6 months)
An additional assessment point was added in August 2020 (to be completed as soon as possible by all participants) to investigate the impact of the COVID-19 pandemic. This consists of an online questionnaire (that participants can complete over the phone if required) and qualitative interviews (with up to 300 participants). We are focusing on a number of different topics in different interviews (and when participants are invited to an interview, they are told what the topics would be):
- how the covid pandemic has impacted the lives and health behaviours of those living with and beyond cancer,
- how the pandemic influenced how people responded to various physical symptoms experienced at this time and how those living with and beyond cancer felt about changes to their care during the pandemic
- experiences of those living with and beyond cancer who have been affected by obesity
- the barriers towards physical activity and preferences for different physical interventions for those living with metastatic cancer
We have contact details (names, address, email, telephone, date of birth, NHS Number) and information about when participants are due follow-ups stored in a database, within a secure computer system which uses a “walled garden approach” certified to the ISO27001 information security standard. This information is stored separately from the information provided through the four data collection methods listed above. An ID number is used to link the data to an individual’s contact details. This is called pseudo-anonymised data.
Participants provide data at the start of the trial (baseline), 3 months and 6 months after they are allocated to an experimental group (to receive the intervention or usual care) and, if they choose to, again after 2-3 years.
The COVID-19 questionnaire is administered through a web application where the data is stored directly into the secure computer system. Participants provide consent for this part of the study through this study website. All responses entered in the questionnaire as well as IP address are stored when the questionnaire is completed. If participants complete the questionnaire over the phone the conversation is recorded (the data is entered straight into the web application) and the participant’s full name and consent confirmed in this recording. These recordings are also stored in the secure computer system and retained as proof of consent for this aspect of the study. If participants are invited to participate in an interview in 2021 or 2022 that is not focused on health behaviour changes during the pandemic they will provide consent over the phone and these recordings will also be stored as above.
If participants have consented to us doing so, we will also access their medical records from NHS Digital (previously Public Health England) to consider their longer-term medical outcomes, for up to ten years from the date the consent form was signed. This data will allow us to accurately categorise people in our sample by the types of cancer they were diagnosed with and the stage of these cancers, and to see how their health has changed over time. We will then be able to compare those who received the ASCOT intervention and those who received Usual Care to see if there are differences. If you have consented to us accessing your hospital records then the NHS site where you were diagnosed and/or treated will pass information collected from your medical records to UCL.
To enable us to access medical records from NHS Digital ( previously Public Health England) we will share with them participants’ NHS number (if provided), date of birth, name, gender and postcode. NHS Digital/Public Health England will then match our participants with their data held in the National Cancer Registration and Analysis Service –(http://www.ncras.nhs.uk/). The cancer registry holds information on cancer diagnoses, hospital attendances and admissions, treatment information/medication, other illnesses and survival data. Rights to access, change or move information is limited, as we need to manage information in specific ways in order for the research to be reliable and accurate. If a participant withdraws from the study, we will keep the information that we have already obtained. To safeguard participant’s rights, we will use the minimum personally-identifiable information possible (i.e. we will remove name and address but may retain cancer type and hospital where treated). If a participant removes consent for us to access medical records and we have not yet accessed this data, we will not do so. If we have already accessed the data then we will retain this.
The ASCOT Trial is based at UCL, with collaborators at the University of Leeds. The ASCOT Team at UCL, and the University of Leeds, will use your name, and contact details to contact you about the research and to oversee the quality of the study. Individuals from UCL and regulatory organisations may look at your research records to check the accuracy of the research study. The only people in UCL, or the University of Leeds, who will have access to information that identifies you will be people who need to contact you to arrange data collection or to take your dietary information, to invite you to participate in or conduct semi-structured interviews with you, to audit the data collection process, or liaise with NHS Digital (previously Public Health England) to access your medical records.
Your questionnaires are entered into electronic data files by a company called Abacus Data & Mailing Ltd. These questionnaires will only use your study ID number to identify you, and no personally identifiable data will be shared with Abacus Data & Mailing Ltd. Prior to November 2020 audio recordings of telephone calls with you (qualitative interviews) were transcribed into a text document by a company called Way With Words Ltd. or Devon Transcription. Interviews conducted after November 2020 will be transcribed by a company called TPTranscription. Audio files will be saved under ID numbers and any potentially identifying details that are included in the written transcripts will be removed as early as possible. Direct quotes from these telephone calls may be used in presentations, written reports, journal publications or for teaching purposes, but it will not be possible to personally identify you. These recordings are stored on our secure computer system and no other use will be made of the original recordings without your written permission, and no one outside the project will be allowed access to the original recordings.
At the end of the study (no later than 2030) we will delete the file which links ID numbers with contact details, making the data held completely anonymous. All data used in publications will be completely anonymous.
The study may need to be inspected or audited by regulatory authorities such as Research Ethics Committee, HRA or UCL Joint Research Office or the NHS Trusts’ R&D. If this is the case they may have access to the data in order to check that the study is being carried out appropriately.
Your personal information will only be used for the purpose of health and care research, and cannot be used to affect your care. It will not be used to make decisions about future services available to you.
Contacts for Further Information
If you have any questions please feel free to contact Dr Lally or Dr Fisher
Dr Phillippa Lally email: p.lally@ucl.ac.uk Telephone: 020 7679 1691
Dr Abigail Fisher email: abigail.fisher@ucl.ac.uk, telephone: 0207679 1722
