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New treatment option for Neoplasm of Breast
Official title Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer
ClinicalTrials.gov ID: NCT04794075
What this study is testing
- What it's testing
- To compare the efficacy of the addition of a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone, on the management of adverse events (AEs) related to adjuvant hormone therapy during the first year of treatment in patients with non-metastatic breast cancer.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Female patients aged 18 to 75 years inclusive
- Patients with non-metastatic breast cancer for whom adjuvant hormone therapy (anti-oestrogen or anti-aromatase) is indicated, depending on the...
- Performance status (ECOG) ≤ 2
- Patient able to read and understand French (common use)
- Patient with access to an internet connection (for collection of adverse events and responses to questionnaires on the electronic platform)
You likely can't join if
- Patient with metastatic cancer (stage IV)
- Patient undergoing neoadjuvant hormone therapy
- Patient who started hormone therapy prior to inclusion in the study
- Patient with a history of other cancer treated by radiotherapy, chemotherapy or hormone therapy, with an end of treatment less than 2 years ago.
- For patients in the experimental group: Inability of the patient to travel to the hospital to attend the initial assessment day and the proposed...
- For patients in the control group: patients for whom telephone nursing follow-up is planned for 2 months or more or more than 4 sessions of...
See the full eligibility criteria
- Female patients aged 18 to 75 years inclusive
- Patients with non-metastatic breast cancer for whom adjuvant hormone therapy (anti-oestrogen or anti-aromatase) is indicated, depending on the decision of the multidisciplinary consultation meeting.
- Performance status (ECOG) ≤ 2
- Patient able to read and understand French (common use)
- Patient with access to an internet connection (for collection of adverse events and responses to questionnaires on the electronic platform)
- Patient who has been informed and has given written consent to participate in the study
- Patient affiliated to the French social security system or equivalent
- Patient with metastatic cancer (stage IV)
- Patient undergoing neoadjuvant hormone therapy
- Patient who started hormone therapy prior to inclusion in the study
- Patient with a history of other cancer treated by radiotherapy, chemotherapy or hormone therapy, with an end of treatment less than 2 years ago.
- For patients in the experimental group: Inability of the patient to travel to the hospital to attend the initial assessment day and the proposed group outpatient workshops; follow-up of the program difficult for...
- For patients in the control group: patients for whom telephone nursing follow-up is planned for 2 months or more or more than 4 sessions of therapeutic education.
- Pregnant and breastfeeding women
- Patient with a documented history of cognitive or psychiatric disorders
- Refusal to participate, protected adult patient, under guardianship or curatorship
The study team makes the final eligibility decision.
Where it's taking place
- Bourg-en-Bresse, France
- Caluire-et-Cuire, France
- Carcassonne, France
- Contamine-sur-Arve, France
- Le Puy-en-Velay, France
- Mantes-la-Jolie, France
- Montélimar, France
- Saint-Priest-en-Jarez, France
- Villeurbanne, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bourg-en-Bresse, France; Caluire-et-Cuire, France; Carcassonne, France; Contamine-sur-Arve, France; Le Puy-en-Velay, France; Mantes-la-Jolie, France and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.