Clinical trial NCT04794075: Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasm of Breast
Keywords: Therapeutic Education
Nursing Support Program
Hormone Therapy
Non-metastatic Breast Cancer
Breast Cancer
Lead sponsor: Centre Hospitalier Emile Roux
Sponsor class: OTHER
Collaborators: name: University Hospital, Clermont-Ferrand
name: Walisco
First posted: 2021-03-11
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experiment group
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 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)
* Patient who has been informed and has given written consent to participate in the study

Exclusion Criteria:

* Patient with metastatic cancer
* 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

Primary outcomes:
measure: 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.
timeFrame: For a year
Secondary outcomes:
measure: 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.
timeFrame: Change from baseline at Month 6 and Month 12
measure: 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.
timeFrame: Change from baseline at Month 6 and Month 12
measure: 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.
timeFrame: From date of first Hormone Therapy intake to 12 months
measure: To compare the effectiveness of adding the program to conventional management alone in terms of therapeutic compliance at Month 6 and Month 12.
timeFrame: Change from Month 6 and Month 12
measure: 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.
timeFrame: Change from baseline at Month 6 and Month 12
measure: To compare the effectiveness of adding the program to conventional management alone in terms of patients' level of knowledge about the disease and treatment.
timeFrame: Change from baseline at Month 2
measure: To compare the effectiveness of adding the program to conventional management alone in terms of patients' satisfaction with their care at Month 12.
timeFrame: For a year
measure: 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.
timeFrame: For a year
measure: To assess patient interest in and adherence to the proposed program in the experimental group.
timeFrame: For a year
measure: To describe the non-drug means used by patients to manage their adverse events.
timeFrame: For a year
Other outcomes:
Locations:
city: Carcassonne
country: France
facility: CH de Carcassonne
city: Le Puy-en-Velay
country: France
facility: Centre Hospitalier Emile Roux
Study officials:
affiliation: Centre Hospitalier Emile Roux
name: Séverine Breysse
role: PRINCIPAL_INVESTIGATOR
References: