RecruitingOBSERVATIONAL

Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery (OnCoPRO Value)

This study, called OnCoPRO Value, is looking into breast cancer surgery. It aims to understand how various surgical approaches affect cancer results, how a patient's breast looks after surgery, and their overall quality of life. The research focuses on breast-conserving surgery for women with early breast cancer or pre-invasive changes. Researchers want to create a standard way to assess surgical options and help doctors and patients make shared decisions about treatment. The goal is to ensure patients receive the most effective and personalised care possible, balancing successful cancer treatment with good cosmetic outcomes and a high quality of life.

At a glance

Status

Recruiting

Sponsor

Uppsala University

Enrolment target

1,200

Start

01 Jan 2020

Estimated completion

30 Dec 2032

Breast Cancer Breast Carcinoma in Situ Breast Cancer Invasive Breast Asymmetry

What is this study about?

This study is dedicated to improving breast cancer surgery for women who need to have a lump or cancerous tissue removed while keeping as much of their breast as possible. It's looking particularly at a type of surgery called 'oncoplastic breast-conserving surgery' (OPBCS). This surgery is becoming more common because it allows surgeons to remove larger areas of cancer while still aiming for a good cosmetic result by reshaping the breast.

The researchers want to understand the best ways to perform these surgeries and how they affect patients. They're looking at several important aspects: how well the cancer is treated, how the breast looks after surgery, and, crucially, how the surgery impacts a patient's quality of life. Currently, there isn't a lot of standard information about when to use specific techniques or how to make decisions about them, as each patient's breast shape, size, and cancer are unique.

By carefully studying these different surgical approaches, the OnCoPRO Value study hopes to develop clearer guidelines and tools. This will help doctors and patients work together to make the best treatment choices. The ultimate aim is to ensure that patients not only receive successful cancer treatment but also experience the best possible cosmetic outcome and maintain a good quality of life afterwards, avoiding unnecessary procedures or complications.

Key takeaways

Exploring ways to improve breast cancer surgery outcomes.
Focuses on preserving the breast while effectively treating cancer.
Aims to balance cancer treatment, appearance, and quality of life.
Hopes to create clearer guidelines for surgical decisions.
Seeks to understand the effects of different surgical techniques.

Who may be eligible?

To be considered for this study, you would need to be a woman aged 18 or older. You'd also need to be able to understand the study information and give your consent to take part.

The study is for women who have invasive breast cancer, ductal carcinoma in situ (an early form of breast cancer), or other suspicious or benign breast lumps that require surgery to remove them, specifically with the aim of preserving the breast.

However, some things would mean you couldn't join. This includes if you have a life expectancy of less than 6 months, if breast preservation surgery isn't suitable for your particular situation, or if you're unable to provide informed consent or follow the study procedures.

Quick self-check

Are you a woman aged 18 or over?
Do you have invasive breast cancer, early breast cancer (DCIS), or a lump requiring breast-preserving surgery?
Are you able to understand study information and give your consent?
Are you able to undergo standard study procedures?
Is breast preservation an option for your cancer treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

The description provided doesn't specify the exact details of what taking part would involve in terms of visits, assessments, or duration. It mentions that you would need to give your signed consent before starting any specific study procedures. There's also a mention of some participants providing oral consent for a quality control retrospective cohort study that involves a telephone interview. Generally, studies like this might involve a series of assessments before and after surgery, potentially including questionnaires about your quality of life and breast appearance, and possibly follow-up appointments over a period to monitor your recovery and outcomes. The study does not mention any specific medication being tested.

Potential risks and benefits

Taking part in a study like this could offer potential benefits by contributing to a better understanding of breast cancer surgery, which might lead to improved care for future patients. For you, it could mean closer monitoring of your surgical outcome and quality of life. Potential risks are generally associated with the standard surgical procedures themselves, as the study appears to be observing existing practices rather than testing new interventions. It's important to remember that you would have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (3)

Westmead Breast Cancer Institute
Sydney, Australia· Recruiting
Uppsala University Hospital
Uppsala, Sweden· Recruiting
Royal Marsden Hospital
London, United Kingdom· Recruiting

Common questions

What kind of breast cancer is this study for?

This study is for women with invasive breast cancer, very early breast cancer (ductal carcinoma in situ), or other lumps that require surgery where preserving the breast is an option.

What is 'oncoplastic breast-conserving surgery'?

This is a type of breast surgery that removes cancerous tissue while also reshaping the breast to try and achieve the best possible cosmetic appearance.

Will I receive a new or experimental treatment if I join?

The study seems to be observing existing surgical practices rather than testing a completely new treatment. The goal is to understand and improve current methods.

What is 'quality of life' in this study?

Quality of life in this study refers to how surgery affects your overall well-being, including your physical and emotional comfort, and how satisfied you are with the results.

Will my information be kept private?

While not explicitly stated in the summary, all clinical studies in the UK are required to protect participant's privacy and confidentiality according to strict guidelines.

How to find out more

Andreas U Karakatsanis, MD, PhD

andreas.karakatsanis@uu.se +46765864826 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.