Active not recruitingNAINTERVENTIONAL

Primary Hormone-sensitive Breast Cancer: Need-driven Health Care Improvement by Patient-centred Digital Application

This study is testing a new way to support women who have early-stage breast cancer that's sensitive to hormones. Researchers want to see if using a special digital app can help them feel better and take their medication as prescribed. When breast cancer patients start hormone therapy, it can sometimes have side effects that make it hard to keep taking the medicine, which can affect their recovery. This study will compare how patients using the app fare against those receiving standard care. The app aims to monitor how patients are doing and alert their care team if they need extra support, hopefully leading to better health and fewer problems with treatment.

At a glance

Status

Active not recruiting

Phase

Sponsor

Technical University of Munich

Enrolment target

400

Start

01 Jan 2022

Estimated completion

01 Jun 2026

New Healthcare Approach

What is this study about?

This research study is looking for ways to improve the care for women diagnosed with a common type of early-stage breast cancer, known as hormone-sensitive breast cancer. When someone has this type of cancer, they are often given hormone therapy after other treatments like surgery. This therapy is very important for reducing the chance of the cancer coming back.

However, taking hormone therapy can sometimes be challenging. Patients might experience side effects that can make them feel unwell or stressed, and this can sometimes lead to them stopping their medication too early without their doctor's advice. When patients don't stick to their treatment plan, it can unfortunately increase the risk of the cancer returning or getting worse. This study aims to find out if using a new digital app can help patients manage their treatment better, improve their overall well-being, and make it easier for them to continue taking their necessary medication.

The study will compare two groups of patients. One group will receive their usual care, while the other group will also use the new digital app. The app is designed to regularly check how patients are feeling and if they're having any difficulties with their treatment. If the app detects any problems, it will let the breast care team know, so they can offer help and support quickly. Researchers hope this approach will help patients feel more supported, improve their quality of life, and ensure they get the full benefits of their treatment.

Key takeaways

Tests a digital app for women with early hormone-sensitive breast cancer.
Aims to improve quality of life and help patients stick to their hormone medication.
Compares digital app users with those getting standard care.
The app monitors well-being and treatment issues, alerting the care team if needed.
Focuses on improving support and health outcomes for patients.

Who may be eligible?

This study is looking for women who have been recently diagnosed with a specific type of early-stage breast cancer, called hormone-sensitive breast cancer. You would be considered if your doctor has recommended hormone therapy, such as tamoxifen or aromatase inhibitors, and you started this treatment within the last three months. You also need to have public health insurance to take part.

To be eligible, you must be able to use the internet and digital apps, and be able to understand and follow the study instructions. Additionally, you must be willing to give your informed consent, which means you agree to participate after understanding what the study involves.

However, you cannot join if you don't use the internet or digital apps, or if your breast cancer has spread to other parts of your body (advanced or metastatic breast cancer). If you have other serious health conditions, or if your life expectancy is less than two years, you wouldn't be able to participate. The study is open to women aged 18 and over.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or older?
Do you have early-stage hormone-sensitive breast cancer?
Did you start hormone therapy (like Tamoxifen) within the last 3 months?
Do you use the internet and digital apps?
Do you have public health insurance?
Are you able to understand and agree to participate?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be assigned to one of two groups. One group will continue with their usual care, and the other group will use a special digital app in addition to their usual care. Throughout the study, you'll be asked to complete questionnaires that ask about your quality of life, any distress you might be feeling, and how well you're managing your medication. This information will help the researchers understand the effect of the digital app. The study aims to follow participants for a period, though the exact duration isn't specified, these questionnaires will be a key part of your involvement. There are no mentions of extra clinic visits or new medications being given, beyond your prescribed hormone therapy.

Potential risks and benefits

Taking part in this study might offer some potential benefits, particularly if you are in the group using the digital app. The app is designed to help monitor your well-being and medication adherence, potentially leading to quicker support from your healthcare team if issues arise, which might improve your quality of life. For the wider community, the study could help develop better support systems for women with breast cancer. As for risks, there are no new medications or invasive procedures involved, so physical risks are expected to be minimal. The main involvement is completing questionnaires and potentially using an app, which could take some time or effort. Please remember, you are free to withdraw from the study at any time without having to give a reason, and this will not affect your usual medical care.

Locations (1)

Klinikum rechts der Isar, Frauenklinik, Technische Universität München
Verified postcode
Munich, Germany

Common questions

What is 'hormone-sensitive breast cancer'?

This is a type of breast cancer that grows in response to hormones in the body. Hormone therapy works by blocking these hormones or reducing their levels to stop the cancer from growing.

What does 'therapy-adherence' mean?

This simply means taking your medication exactly as prescribed by your doctor – for example, taking it at the right time and not missing doses.

Will I have to pay for the digital app?

No, if you are in the group assigned to use the digital app, it will be provided as part of the study, and you won't have to pay for it.

What is 'standard of care'?

Standard of care refers to the usual or widely accepted treatments and care you would normally receive for your condition, based on current medical guidelines.

If I join, what kind of questions will I be asked?

You will be asked questions about how you are feeling, your quality of life, any worries you might have, and how you are managing to take your hormone therapy medication.