Feasibility Study to Evaluate the Use of Patient Reported Complications After Digital Consent
This study is for women with early breast cancer having specific surgery. It explores using online forms to collect information directly from patients about any complications (problems) they experience after their operation. We want to find out if patients reliably report these issues, how good the information is, and if it matches what they were told before surgery. The goal is to make sure that the information discussed before an operation accurately reflects what happens afterwards. This could help improve how patients give consent and allow doctors to better understand and discuss potential side effects, leading to more personalised care for future patients.
At a glance
What is this study about?
This research study is looking into how patients who have had breast cancer surgery report their recovery and any problems that might come up afterwards. When you agree to have an operation, doctors talk to you about possible side effects and risks. This study wants to see if the information patients provide about their experience after surgery matches what they were told beforehand. It's about making sure that what's written on a consent form truly reflects what happens to people.
The study is trying out a new way for patients to share this information: through an online form. We want to understand if patients are happy to report what happened, if the details they give are useful, and if this online method works well. Right now, doctors usually rely on their own observations or what patients tell them in appointments to track complications. With more types of follow-up care moving online or being led by patients, it's important to know if this might mean some problems are missed.
Ultimately, if collecting this kind of information directly from patients turns out to be reliable, it could lead to much better discussions between doctors and patients about surgery. It could help make sure that when you make a decision about treatment, you have the most up-to-date and accurate picture of what to expect, based on the real experiences of other patients.
Key takeaways
- The study aims to understand how patients report problems after breast cancer surgery.
- It uses online forms or phone calls for patients to share their experiences.
- The goal is to improve information given to patients before surgery.
- It helps doctors get a better picture of real-world outcomes.
- Participation will not change your medical treatment.
- Sharing your experience could help improve care for future patients.
Who may be eligible?
This study is looking for women who are at least 18 years old and have been diagnosed with early invasive breast cancer. You would need to be planning to have a specific type of surgery. This surgery involves removing part of the breast and checking the lymph nodes in the armpit.
To join, you must be able to understand the study and give your own permission to take part. You also need to be able to fill in an electronic questionnaire (like an online form) or answer questions over the phone.
If you need an interpreter to understand discussions or cannot give consent for yourself, then this study would not be suitable for you.
- Are you 18 years old or older?
- Are you a woman diagnosed with early invasive breast cancer?
- Are you having a Wide Local Excision (lumpectomy) and sentinel lymph node biopsy?
- Can you give your own consent to join the study?
- Can you fill in an online form or answer questions over the phone?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you decide to take part in this study, your involvement would mostly be about providing information. After your surgery, you would be asked to fill out an electronic questionnaire (an online form), or answer questions during a phone call. This questionnaire or phone call would ask you about any problems or complications you've experienced since your operation. The study does not involve taking any new medications, having extra appointments, or changing your usual medical care. The total duration of your participation would be for the period where you are asked to report your post-surgery experience.
Potential risks and benefits
Locations (1)
- Queen Alexandra HospitalPortsmouth, United Kingdom· Recruiting
Common questions
What is 'digital consent'?
Digital consent means you give your permission for treatment or to join a study using an electronic form or online system, instead of just on paper.
What does 'Patient Initiated Follow Up (PIFU)' mean?
PIFU means that after your treatment, you decide when you need to contact the hospital or clinic for an appointment, rather than having regular scheduled appointments.
Will my privacy be protected if I take part?
Yes, your personal medical information will be kept confidential, meaning it will be used only for this study and not shared without your permission.
Do I have to live in a specific area to join?
The study does not specify a location, but you will need to be having your surgery at a hospital involved in this specific research.
Will taking part affect my breast cancer treatment?
No, taking part in this study will not affect your standard breast cancer treatment or the care you receive.
How to find out more
Ian Gedge
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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