Quality of life after surgery and other options to prevent cancer of the lining of the womb (endometrial cancer)
| ISRCTN | ISRCTN17432105 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17432105 |
| IRAS number | 280449 |
| Secondary identifying numbers | IRAS 280449, CPMS 54165 |
- Submission date
- 10/11/2022
- Registration date
- 17/12/2022
- Last edited
- 07/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
The PRESCORES study is designed to help prevent cancers of the lining of the womb (also called endometrial cancer). Some women are at increased risk of womb cancer. This includes women with Lynch Syndrome, who are at very high risk. Those people may have surgery to remove the womb to prevent this cancer. This surgery is called "risk-reducing hysterectomy". It is unknown whether other people who are not at such high risk of womb cancer as women with Lynch Syndrome would also benefit from this surgery.
The aim of this study is to understand the quality-of-life of women who have risk-reducing hysterectomy. Once we understand this, we can use health economic modelling to work out who else would benefit from this surgery. We want to find out how high a person's lifetime risk of womb cancer must be for this surgery to be beneficial, and cost-effective. After finding this out, we want to see whether people from the general population would find it acceptable to be offered a risk-reducing hysterectomy, if they found out that they had an increased risk of womb cancer.
Who can participate?
Women with Lynch Syndrome who live in the UK can participate in this part of the study. They must be over 18 years of age.
What does the study involve?
Participants who wish to join the study will complete a short consent form, before completing a questionnaire. This questionnaire asks for some background medical information, the quality of life of participants, cancer worry, and certain demographic questions. This questionnaire takes around 10-15 minutes to complete. Participants completing the study on paper must return the completed consent form and questionnaire in an enclosed self-addressed freepost envelope. Participants completing the study online will simply submit when finished. After this, there is no further involvement of participants in the study.
What are the possible benefits and risks of participating?
There are unlikely to be immediate benefits from participating in this study, except for the satisfaction of having contributed towards this research on endometrial cancer prevention.
Participants, along with other women at risk of endometrial cancer, may benefit from the knowledge gained in this study if they are considering risk-reducing surgery to prevent endometrial cancer in future.
As this is a questionnaire-based study there are few risks to participants. Potential participants may find it difficult to complete the study due to the sensitive or personal nature of some questions (eg regarding cancer risk and medical history). They are free to not continue or withdraw from the study at any time without giving a reason. Information about support charities such as Lynch Syndrome UK is provided.
Where is the study run from?
Queen Mary University of London (UK)
When is the study starting and how long is it expected to run for?
January 2022 to January 2025
Who is funding the study?
RoseTrees Trust (UK)
Who is the main contact?
Professor Ranjit Manchanda, r.manchanda@qmul.ac.uk
Contact information
Principal Investigator
Wolfson Institute of Population Health
Queen Mary University of London
Charterhouse Square
London
EC1M 6BQ
United Kingdom
 ORCID ID |
0000-0003-3381-5057 |
|---|---|
| Phone | +44 2078828491 |
| r.manchanda@qmul.ac.uk |
Public
Wolfson Institute of Population Health
Queen Mary University of London
Charterhouse Square
London
EC1M 6BQ
United Kingdom
| ORCID ID |
0000-0003-1967-813X |
|---|---|
| Phone | +44 2078828491 |
| s.oxley@qmul.ac.uk |
Scientific
Wolfson Institute of Population Health
Queen Mary University of London
Charterhouse Square
London
EC1M 6BQ
United Kingdom
| Phone | +44 2078828491 |
|---|---|
| s.oxley@qmul.ac.uk |
Study information
| Study design | Multicentre questionnaire-based cross-sectional cohort survey |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Prevention of endometrial cancers: comparing risk-reducing strategies |
| Study acronym | PRESCORES |
| Study hypothesis | This study will determine who would benefit from preventive strategies for endometrial cancer. It will obtain measures of health-related quality of life (called utility scores) for risk-reducing hysterectomy performed for endometrial cancer prevention. These utility scores will then be used in health economic modelling, called cost-utility analysis. This will determine the lifetime individual risk of endometrial cancer at which someone would benefit from risk-reducing hysterectomy. |
| Ethics approval(s) | 1. Approved 05/12/2022, London - Surrey Research Ethics Committee (Nottingham Centre, Nottingham, NG1 6FS, United Kingdom; N/A; surrey.rec@hra.nhs.uk), ref: 22/PR/1167 2. Approved 05/10/2022, Surrey Research Ethics Committee (The Old Chapel, Royal Standard Place, Nottingham, NG1 6FS, UK; +44 207 1048 088; surrey.rec@hra.nhs.uk), ref: 22/PR/1167 |
| Condition | Lynch syndrome |
| Intervention | Potential participants will be contacted by their usual treating team, or via support charities such as Lynch Syndrome UK (for individuals who have previously voluntarily signed up to such mailing lists). This can be either via post or online. They will be able to read a simple summary page about the study (cover letter). For potential participants reading this online wishing to progress, they must first complete a very short screening questionnaire to establish eligibility. This will not be necessary for potential participants receiving paper copies as they will have been screened by their treating clinical team. Potential participants will be able to read the Participant Information Sheet. If an individual wishes to participate, they must sign the study consent form. They may then complete the study questionnaire. Participants who complete the study on paper must return the signed consent form and completed questionnaire in the enclosed self-addressed freepost envelope. This ends the involvement of participants in this study. |
| Intervention type | Other |
| Primary outcome measure | Health-related utility scores for risk-reducing hysterectomy for endometrial cancer prevention, measured using EQ-5D questionnaire at baseline |
| Secondary outcome measures | 1. Variables predictive for risk reducing hysterectomy, measured using a customised questionnaire alongside EQ-5D at baseline 2. Separate health-related utility scores for pre and post-menopausal patients undergoing risk-reducing hysterectomy with and without ovarian conservation, measured using a customised questionnaire alongside EQ-5D at baseline 3. Endometrial cancer risk threshold for undergoing risk-reducing hysterectomy, using Markov modelling to perform cost-utility analysis, following collection of EQ-5D data. 4. Cost-effectiveness of risk-reducing hysterectomy, using Markov modelling to perform cost-utility analysis, following collection of EQ-5D data. 2. Costs will be measured using a UK public healthcare system (payers) perspective, with values derived from the literature. A lifetime horizon will be used with appropriate discounting. Cost-effectiveness will be calculated using the incremental cost-effectiveness ratio (ICER), and compared against the willingness-to-pay threshold from the UK National Institute of Health and Care Excellence of £20,000 - £30,000 per quality-adjusted life year (QALY). |
| Overall study start date | 01/01/2022 |
| Overall study end date | 01/01/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 750 |
| Participant inclusion criteria | 1. Female 2. Age >18 years old 3. Lynch Syndrome diagnosis - confirmed germline mutation in MLH1, MSH2, MSH6, PSM2, ECPAM 4. UK Resident |
| Participant exclusion criteria | 1. Unwilling or unable to provide informed consent 2. Inability to understand written and verbal English |
| Recruitment start date | 13/06/2023 |
| Recruitment end date | 31/12/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
80 Newark Street
London
E1 2ES
United Kingdom
Sponsor information
University/education
Joint Research Management Office (JRMO)
Research Services
Dept. W
69-89 Mile End Road
London
E1 4UJ
England
United Kingdom
| Phone | +44 20 7882 8002 |
|---|---|
| research.governance@qmul.ac.uk | |
| Website | http://www.jrmo.org.uk/about-us/contact-us/ |
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Charity
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Teresa Rosenbaum Golden Charitable Trust, Rosetrees
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/01/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal, and presentation at national and international conferences |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from Prof. Ranjit Manchanda (r.manchanda@qmul.ac.uk). Anonymised data can be shared upon reasonable request, containing no identifiable information such as name or date of birth. This would be potentially available after study completion, from 2025 onwards, or after publication of results (whichever comes first). Written consent from all participants is required and is obtained. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Protocol file | version 3.0 | 07/02/2024 | No | No |
Additional files
Editorial Notes
07/02/2024: The following changes were made to the study record:
1. Protocol uploaded.
2. Ethics approval details, study website and IPD sharing plan added.
3. The recruitment start date was changed from 01/12/2022 to 13/06/2023.
4. The recruitment end date was changed from 01/12/2024 to 31/12/2024.
16/01/2023: Internal review.
18/11/2022: Trial's existence confirmed by Queen Mary University of London.
