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

Centre Hospitalier Emile Roux

Status

Enrolling

Conditions

Neoplasm of Breast

Treatments

Other: Therapeutic Education and Nursing Support Program for Supportive Care

Study type

Interventional

Funder types

Other

Identifiers

NCT04794075

RIPH2_BREYSSE_ETAPH

2020-A03074-35 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 estimated patients

Sex

Female

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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