All studies
RecruitingNAINTERVENTIONAL

Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer

This study, called ETAPH, aims to help women with breast cancer who are taking hormone therapy after their main cancer treatment. The hormone therapy is important to reduce the chance of the cancer coming back, but it can sometimes cause side effects. This research wants to see if adding a special education programme and regular phone calls with a nurse helps patients manage these side effects better and improves their overall quality of life during the first year of treatment. Participants will either receive this extra support or continue with their usual care. The goal is to provide personalised care that limits the impact of treatment side effects.

At a glance

Status
Recruiting
Phase
NA
Sponsor
Centre Hospitalier Emile Roux
Enrolment target
300
Start
09 Aug 2021
Estimated completion
01 Aug 2027

What is this study about?

When you have breast cancer, sometimes after your initial treatment like surgery, your doctors might recommend hormone therapy. This treatment is very important because it helps to lower the risk of the cancer returning. However, like many medicines, hormone therapy can sometimes have side effects that can affect how you feel day-to-day. This study is all about helping women like you manage those side effects.

The researchers want to find out if giving extra support makes a difference. This support comes in two main parts: a special education programme where you can learn more about your treatment and how to cope with side effects, and regular phone calls with a nurse who can listen to your concerns and offer advice. They believe that this combination of education and one-on-one nursing support could lead to a better experience and improved quality of life during your first year on hormone therapy.

To see if this extra support really works, the study will compare women who receive this new programme with women who receive the usual excellent care from their doctors. By doing this, they hope to improve the way patients are supported and cared for while undergoing hormone therapy for breast cancer, making your journey a little easier.

Key takeaways

  • The study aims to help women manage side effects of hormone therapy for breast cancer.
  • It compares a special education and nursing support programme with usual care.
  • Participation lasts for the first year of hormone therapy.
  • No new medicines are involved; the focus is on supportive care.
  • It's for women with breast cancer that hasn't spread and who are starting hormone therapy.

Who may be eligible?

This study is looking for women between 18 and 75 years old who have been diagnosed with breast cancer that hasn't spread to other parts of their body (non-metastatic). Your doctors must have decided that hormone therapy, such as anti-oestrogen or anti-aromatase drugs, is the right treatment for you after your initial cancer treatment.

To take part, you should be able to read and understand French, as some materials might be in this language, and have access to the internet, as some information will be collected online. You must also be generally well enough to participate in daily activities and willing to give your written permission to join the study.

There are some reasons why you wouldn't be able to join. For example, if your cancer has spread, if you've already started hormone therapy before the study, or if you've been treated for another cancer within the last two years. If you're pregnant or breastfeeding, or have certain cognitive or mental health conditions, you also wouldn't be able to participate. Also, if you’re in the group receiving the special programme, you need to be able to attend initial hospital workshops; similarly, if you're in the usual care group, you shouldn't already have plans for similar intensive phone or education support.

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.

  1. Are you a woman between the ages of 18 and 75?
  2. Do you have breast cancer that has not spread to other parts of your body?
  3. Are you about to start or have you recently started hormone therapy for your breast cancer?
  4. Do you have internet access and can you read and understand French?
  5. Are you able to attend appointments at the hospital if you're in the special support group?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would either receive the special education and nursing support programme or continue with your usual excellent care. Regardless of which group you're in, the study will involve collecting information about how you're feeling and any side effects you experience over the first year of your hormone therapy treatment. This will mainly be done through questionnaires on an online platform.

If you are in the special programme group, you would attend an initial assessment day at the hospital and some group workshops. You would also receive regular phone calls from a nurse for ongoing support. If you're in the usual care group, you'd continue with your standard medical appointments and follow-up as advised by your healthcare team.

The overall duration of your participation in the study would be for the first year that you are receiving hormone therapy. There are no specific medications provided by the study, as it focuses on supporting you through the hormone therapy your doctors have already prescribed.

Potential risks and benefits

Participating in this study might offer you some potential benefits, especially if you're in the special programme group, as you could receive extra support and education to help manage side effects and improve your quality of life during your hormone therapy. Even if you're in the usual care group, your participation will help researchers learn more, which could benefit future patients. The main risk involved is the time commitment required for completing questionnaires and, for the experimental group, attending workshops and phone calls. There are no new medications or invasive procedures in this study, so medical risks are minimal. You are always free to withdraw from the study at any time and for any reason, without it affecting your medical care.

Locations (9)

  • Centre Hospitalier de Bourg-en-Bresse / Fleyriat
    Verified postcode
    Bourg-en-Bresse, France· Recruiting
  • Clinique De L'infirmerie Protestante De Lyon
    Verified postcode
    Caluire-et-Cuire, France· Recruiting
  • CH de Carcassonne
    Verified postcode
    Carcassonne, France· Recruiting
  • CHAL - Centre Hospitalier Alpes Léman
    Verified postcode
    Contamine-sur-Arve, France· Not yet recruiting
  • Centre Hospitalier Emile Roux
    Verified postcode
    Le Puy-en-Velay, France· Recruiting
  • Centre Hospitalier François Quesnay
    Verified postcode
    Mantes-la-Jolie, France· Recruiting
  • Groupement Hospitalier Portes de Provence
    Verified postcode
    Montélimar, France· Not yet recruiting
  • Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord
    Verified postcode
    Saint-Priest-en-Jarez, France· Recruiting
  • Médipôle Lyon-Villeurbanne
    Verified postcode
    Villeurbanne, France· Recruiting

Common questions

What is 'non-metastatic breast cancer'?

This means your breast cancer has not spread from your breast to other parts of your body.

What is 'adjuvant hormone therapy'?

This is a type of treatment given after your main cancer treatment (like surgery) to help reduce the risk of the cancer coming back, using medicines that affect hormones.

Will I have to take new medicines as part of this study?

No, this study doesn't introduce new medicines. It focuses on supporting you while you're taking the hormone therapy your doctor has already prescribed.

How long will I be in the study?

You would be part of the study for the first year of your hormone therapy treatment.

What if I change my mind about participating?

You are free to leave the study at any time without giving a reason, and it won't affect your medical care.

How to find out more

Émilie GADEA, PhD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Therapeutic Education and Nursing Support Program for Suppor…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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