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Contact Information:

Dr Charlotte Davies
+44 (0)117 9287209
Charlotte.Davies@bristol.ac.uk


Miss Shelley Potter
+44 (0)117 9287218
Shelley.Potter@bristol.ac.uk


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Be Part of Research - Trial Details - A study to determine the feasibility of undertaking a large scale study comparing the clinical and patient-reported outcomes of oncoplastic breast conservation as an alternative to mastectomy with or without immediate breast reconstruction
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A study to determine the feasibility of undertaking a large scale study comparing the clinical and patient-reported outcomes of oncoplastic breast conservation as an alternative to mastectomy with or without immediate breast reconstruction

Not Recruiting

Open to: Female

Age: Adult

NOTTINGHAM Coventry Liverpool Bristol

Medical Conditions

Breast reconstruction after breast cancer diagnosis

This information is provided directly by researchers and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information.


Breast-conserving surgery (BCS) is the preferred treatment for many women with breast cancer. However, standard techniques frequently result in poor cosmetic outcomes and mastectomy (removal of the breast) with or without immediate breast reconstruction is often recommended. Currently, 40% of the 55,000 women diagnosed with breast cancer each year undergo a mastectomy but of these only 1 in 4 receive reconstruction. Oncoplastic breast conservation surgery (OPBCS) describes a range of volume replacement (e.g. local perforator flap [LPF]) and volume displacement techniques (e.g. therapeutic mammaplasty (TM)) that may extend the boundaries of standard BCS and allow some women to avoid mastectomy and potentially improve their quality of life.
There is a need for high-quality research to determine whether OPBCS offers a safe and effective alternative to mastectomy but preliminary work is needed to ensure a future large-scale study is feasible, well-designed and addresses questions important to patients and the NHS. The overall aim of this study is to assess the feasibility of undertaking a large-scale multicentre prospective cohort study to compare the clinical and cost-effectiveness of OPBCS as a safe and effective alternative to mastectomy with and without immediate breast reconstruction (IBR), and to determine the most appropriate outcome measures for use in the main study.
The feasibility study will have four parts:
1. A national survey (a nested service evaluation) to understand the current national practice of OPBCS
2. A pilot study to explore how many women are suitable for OPBCS as an alternative to mastectomy, choose to undergo the procedure, and whether existing patient-reported outcome questionnaires measure outcomes important to patients undergoing different types of surgery accurately and can reliably be used in a future large study
3. Interviews with patients to explore their views of different surgical options and the adequacy of questionnaires used to assess key patient-reported outcomes
4. Design of the future study
This study will be the first-step providing high-quality evidence to support the use of OPBCS as an alternative to mastectomy. It will promote choice, improving outcomes for patients, many of whom will be long-term breast cancer survivors.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Dec 2020 31 Dec 2022

Publications

2021 Protocol article in https://pubmed.ncbi.nlm.nih.gov/33863715/ (added 19/04/2021)

If a woman is considered suitable for OPBRS or mastectomy +/- IBR by her surgeon it will be discussed with her and she will be given time to consider her options. At this point the study will be introduced. If the potential participant chooses to undergo OPBRS or mastectomy +/- IBR, she will be offered the opportunity to join the study. If she consents, demographic details will be recorded and she will be asked to complete questionnaires before surgery and again at 3 and 12 months after surgery. Questionnaires can be completed online or on paper as per patient preference. After the patient has completed the questionnaires she will attend the hospital for surgery shortly after. On the day of surgery, data will be collected including technical details about what was done in the operating theatre and her hospital stay. The clinical team will be responsible for collecting this information, with support from the local clinical research network. Participants will be asked to complete further questionnaires at 3 and 12 months following surgery. It is anticipated that the majority of women will leave the hospital within the first week after surgery, therefore any participant with a device and internet access can consent to be contacted directly by email and prompted to answer the questionnaires directly onto the secure online database. If they do not want electronic questionnaires or do not have internet access via a suitable device (e.g. iPhone or another handheld device/phone), copies will be sent by post. Patients will be asked at the beginning of the study (when signing their consent form) whether they would like to complete questionnaires online or paper. Reminders will be sent by the research team to complete questionnaires if there has been no response from the patient after 1 month. Data regarding additional cancer treatments each patient undergoes (including chemotherapy, radiotherapy or hormone tablets) will also be recorded. Decisions regarding this treatment are usually made within a few weeks of surgery. This data will be collected at 3 months by clinical or case note review depending on local practice.
Patients will be asked if they are willing to be contacted to participate in the interview study at the time of signing the consent form. A sample of patients will be contacted by email or letter and invited to participate in the interview study. They will be sent an interview study patient information sheet and a consent form. Patients agreeing to participate in the interview study will be asked to return their consent form either by post or email in a prepaid envelope provided and to provide contact details to allow an interview to be arranged. The research team will contact consenting participants to arrange a telephone interview at a date and time that is convenient for them. Interviews are anticipated to last about 60 minutes.


Female patients over 18 years of age with invasive breast cancer or ductal carcinoma in situ (DCIS) not considered suitable for standard BCS or simple level 1 techniques who are assessed by the breast cancer (and oncoplastic, if applicable) multidisciplinary team (MDT) and the operating surgeon as being suitable candidates for either OPBCS (therapeutic mammaplasty or local perforator flaps) as an alternative to a mastectomy OR mastectomy with or without an immediate breast reconstruction (using any technique) and offered both OPBCS and mastectomy options. No restrictions will be placed on the size of the tumour as decisions on the suitability of a patient for simple BCS will be based on assessments of the size of the tumour relative to the overall size of the breast and its position within the breast rather than on explicit size criteria.

You can take part if:



You may not be able to take part if:


1. Women offered OPBCS for reasons other than to avoid mastectomy (e.g. quality of life if large breasted) 2. Women offered standard BCS or level 1 procedures only3. Women not able or willing to give informed consent


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Nottingham University Hospitals NHS Trust
    Queens Medical Centre Derby Road
    NOTTINGHAM
    NG7 2UH
  • University Hospitals Coventry and Warwickshire NHS Trust
    Clifford Bridge Road
    Coventry
    CV2 2DX
  • Royal Liverpool and Broadgreen University Hospitals NHS Trust
    Prescot Street
    Liverpool
    L7 8XP
  • North Bristol NHS Trust
    Southmead Hospital Westbury-on-Trym
    Bristol
    BS10 5NB

This is an observational study, recording data about operations which are already happening and would go ahead regardless of inclusion in the study. Patients will not be randomly allocated to treatments. There are no additional clinical risks to study participants other than the intrinsic risk of surgery, which they would accept whether they were included in the study or not.
Patient participants will be asked to complete validated questionnaires before their surgery and then at 3 and 12 months following surgery. Participants will be asked to give consent for data about them to be recorded including baseline demographic data, technical details of their surgery and length of hospital stay, any complications they experience and any additional (“adjuvant”) cancer treatments they undergo. The study has been designed to minimise the burden of participation on patients and clinical teams. Where possible, study data will be entered directly onto a secure online database. Answers to the questionnaires can be entered directly by participants who have internet access and consent to give the email address to the study team. This will minimise additional hospital visits or telephone calls for participants. Those patients who do not have internet access or a suitable tablet or device to upload their own data will be sent questionnaires by post so they do not need to attend the hospital to record their responses.
There is a small risk of causing additional distress at the time the patient is approached about the study. However, breast surgeons are well accustomed to having challenging discussions with patients when they are newly diagnosed with breast cancer. Recruiting surgeons will be instructed to make a judgement on a case-by-case basis about the appropriateness of approaching individual patients about the study based on whether they suspect it would lead to any additional anxiety. The organisation of services will vary between units, but most UK surgical centres have at least two discussions between the breast team and the patient before a final decision about breast surgery is made to give patients time to consider their options. Therefore, it is anticipated that most surgeons recruiting to the study will briefly introduce the study at the end of an initial consultation, and offer potential participants a copy of the patient information leaflet to take away and consider. They will then be followed up by the surgical or research team with another appointment to make firm surgical plans, when study participation could be re-discussed and decided upon. There is a great deal of support available for patients with a new diagnosis of breast cancer starting with their breast care nurse who can signpost to further support as required.

Miss Shelley Potter
+44 (0)117 9287218
Shelley.Potter@bristol.ac.uk


Dr Charlotte Davies
+44 (0)117 9287209
Charlotte.Davies@bristol.ac.uk



The study is sponsored by University of Bristol and funded by Above & Beyond; Association of Breast Surgery.



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Read full details for Trial ID: ISRCTN18238549
Last updated 15 March 2024

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