Recruiting NCT04794075

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

No phase Interventional Neoplasm of Breast

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Therapeutic Education and Nursing Support Program for Supportive Care.
Who it may be relevant to: Registry conditions: Neoplasm of Breast. Basic parameters: 18 years — 75 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: France
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Programme d'Éducation Thérapeutique et d'Accompagnement Infirmier Vers Les Soins de Support, Chez Les Patientes Sous Hormonothérapie Pour un Cancer du Sein Non métastatique

Overview

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.

Detailed description

The main objective of the ETAPH project is to offer breast cancer patients multidisciplinary care that will limit the impact of adverse effects related to hormone therapy treatment and improve their quality of life. The achievement of this objective is based on therapeutic education and nursing follow-up throughout the first year of treatment, which, thanks to active listening and coordination of the various players, will enable global and personalized patient care.

Interventions

Other Therapeutic Education and Nursing Support Program for Supportive Care
In addition to the conventional oncology follow-up, patients will participate in an initial educational assessment day within 15 days before or after their first dose of hormone therapy. A discussion between the patient and the pivot nurse will then make it possible to define personalized objectives, thus guiding the choice of workshops in the outpatient educational program.

Primary outcome measures

To compare the effectiveness of adding a therapeutic education program combined with nursing phone follow-up, compared to conventional management alone on the management of adverse events related to adjuvant hormone therapy. [Time frame: For a year]

Secondary outcome measures (10)

To compare the effectiveness of adding the program to conventional management alone in terms of quality of life for patients on hormone therapy at baseline (Day 0), Month 6 and Month 12. [Time frame: Change from baseline at Month 6 and Month 12]
To compare the effectiveness of adding the program to conventional management alone in terms of sleep quality at baseline (Day 0), Month 6 and Month 12. [Time frame: Change from baseline at Month 6 and Month 12]
To compare the effectiveness of adding the program to conventional management alone in terms of drug use for the management of adverse events throughout the study. [Time frame: From date of first Hormone Therapy intake to 12 months]
To compare the effectiveness of adding the program to conventional management alone in terms of therapeutic compliance at Month 6 and Month 12. [Time frame: Change from Month 6 and Month 12]
To compare the effectiveness of adding the program to conventional management alone in terms of patients' confidence regarding the use of hormone therapy at Day 0, Month 6 and Month 12. [Time frame: Change from baseline at Month 6 and Month 12]
To compare the effectiveness of adding the program to conventional management alone in terms of patients' level of knowledge about the disease and treatment. [Time frame: Change from baseline at Month 2]
To compare the effectiveness of adding the program to conventional management alone in terms of patients' satisfaction with their care at Month 12. [Time frame: For a year]
To compare the effectiveness of adding the program to conventional management alone in terms of medico-economic impact of the program, in terms of cost-utility. [Time frame: For a year]
To assess patient interest in and adherence to the proposed program in the experimental group. [Time frame: For a year]
To describe the non-drug means used by patients to manage their adverse events and their use of supportive care during the study. [Time frame: For a year]

Eligibility criteria

Inclusion 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

Exclusion criteria

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 geographical, physical or other reasons (at the discretion of the investigator).
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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Non-randomized
Model: Parallel assignment
Masking: Open label
Primary purpose: Supportive care

Study locations

France · 9 centers

Centre Hospitalier de Bourg-en-Bresse / Fleyriat — Bourg-en-Bresse
Clinique De L'infirmerie Protestante De Lyon — Caluire-et-Cuire
CH de Carcassonne — Carcassonne
CHAL - Centre Hospitalier Alpes Léman — Contamine-sur-Arve
Centre Hospitalier Emile Roux — Le Puy-en-Velay
Centre Hospitalier François Quesnay — Mantes-la-Jolie
Groupement Hospitalier Portes de Provence — Montélimar
Centre Hospitalier Universitaire de Saint-Étienne - Hôpital Nord — Saint-Priest-en-Jarez
… and 1 more center

Identifiers

NCT: NCT04794075 · RIPH2_BREYSSE_ETAPH · 2020-A03074-35

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗