Back to resultsTherapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer (ETAPH)
Primary Purpose
Neoplasm of Breast
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Therapeutic Education and Nursing Support Program for Supportive Care
Sponsored by
About this trial
This is an interventional supportive care trial for Neoplasm of Breast focused on measuring Therapeutic Education, Nursing Support Program, Hormone Therapy, Non-metastatic Breast Cancer, Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with non-metastatic stage II or stage III hormone-sensitive (RH+) 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 who has been informed and has given written consent to participate in the study
Exclusion Criteria:
- Patient with metastatic cancer
- 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
Sites / Locations
- Centre Hospitalier Emile RouxRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Experimental group with the therapeutic education and nursing support program
Control group
Arm Description
In addition to the conventional oncology follow-up, patients will participate in an initial educational assessments day.
Patients will have the conventional oncology follow-up.
Outcomes
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.
The primary endpoint is the score of the 7 adverse events (AEs), graded on a Likert scale from 0 to 4 points from the NCI-CTCAE v5.0, which will be transformed into a single composite endpoint.
The 7 AEs considered here will be the most frequent and troublesome of the hormone therapy, namely: muscle and/or joint pain, hot flashes, headache, fatigue, insomnia/sleep disturbance, weight gain, nausea. This collection will be done initially (T0) and then monthly by the patients.
Secondary Outcome Measures
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.
The score of the validated Quality of Life of Cancer Patients (EORTC-QLQ-C30) self-questionnaire score, performed at Day 0, Month 6 and Month 12 after initiation of hormone therapy
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.
the score of the validated Pittsburgh sleep quality self-questionnaire during the past month, performed at Day 0, Month 6 and Month 12 after initiation of hormone therapy
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.
The INN name,the daily dosage and duration (number of days) of medication taken between Day 0 and 12 months, will be assessed to compare between the experimental ans the control group in term of medication use
To compare the effectiveness of adding the program to conventional management alone in terms of therapeutic compliance at Month 6 and Month 12.
GIRERD's subjective compliance self-questionnaire score will be filled in at 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.
Patients' confidence in their treatment, assessed on a numerical scale from 0 to 10, measured at Day 0, 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.
Score obtained in the knowledge quizz conducted in Day 0, then at 2 months. This questionnaire is developed by our team based on Likert scales from 1 to 4.
To compare the effectiveness of adding the program to conventional management alone in terms of patients' satisfaction with their care at Month 12.
Score of satisfaction with patient care in relation to the needs they have had over the past 12 months. This questionnaire is developed by our team based on Likert scales from 0 to 3.
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.
the cost-utility ratio of the program will be calculated by estimating the costs incurred/avoided by this program and the evolution of the quality of life of the patients at different times.
To assess patient interest in and adherence to the proposed program in the experimental group.
Refusal rate and program participation rate The rate of premature exit or loss of sight The number and type of workshops attended by patients Evaluation of program content based on Likert scales ranging from 1 to 4.
To describe the non-drug means used by patients to manage their adverse events.
Patients' non-drug management of side effects and use of supportive care will be recorded.
Full Information
NCT ID
NCT04794075
First Posted
February 22, 2021
Last Updated
May 16, 2023
Sponsor
Centre Hospitalier Emile Roux
Collaborators
University Hospital, Clermont-Ferrand, Walisco
1. Study Identification
Unique Protocol Identification Number
NCT04794075
Brief Title
Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer
Acronym
ETAPH
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
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 9, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Emile Roux
Collaborators
University Hospital, Clermont-Ferrand, Walisco
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasm of Breast
Keywords
Therapeutic Education, Nursing Support Program, Hormone Therapy, Non-metastatic Breast Cancer, Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Quasi-experiment group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group with the therapeutic education and nursing support program
Arm Type
Experimental
Arm Description
In addition to the conventional oncology follow-up, patients will participate in an initial educational assessments day.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Patients will have the conventional oncology follow-up.
Intervention Type
Other
Intervention Name(s)
Therapeutic Education and Nursing Support Program for Supportive Care
Intervention Description
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 Measure Information:
Title
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.
Description
The primary endpoint is the score of the 7 adverse events (AEs), graded on a Likert scale from 0 to 4 points from the NCI-CTCAE v5.0, which will be transformed into a single composite endpoint.
The 7 AEs considered here will be the most frequent and troublesome of the hormone therapy, namely: muscle and/or joint pain, hot flashes, headache, fatigue, insomnia/sleep disturbance, weight gain, nausea. This collection will be done initially (T0) and then monthly by the patients.
Time Frame
For a year
Secondary Outcome Measure Information:
Title
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.
Description
The score of the validated Quality of Life of Cancer Patients (EORTC-QLQ-C30) self-questionnaire score, performed at Day 0, Month 6 and Month 12 after initiation of hormone therapy
Time Frame
Change from baseline at Month 6 and Month 12
Title
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.
Description
the score of the validated Pittsburgh sleep quality self-questionnaire during the past month, performed at Day 0, Month 6 and Month 12 after initiation of hormone therapy
Time Frame
Change from baseline at Month 6 and Month 12
Title
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.
Description
The INN name,the daily dosage and duration (number of days) of medication taken between Day 0 and 12 months, will be assessed to compare between the experimental ans the control group in term of medication use
Time Frame
From date of first Hormone Therapy intake to 12 months
Title
To compare the effectiveness of adding the program to conventional management alone in terms of therapeutic compliance at Month 6 and Month 12.
Description
GIRERD's subjective compliance self-questionnaire score will be filled in at Month 6 and Month 12.
Time Frame
Change from Month 6 and Month 12
Title
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.
Description
Patients' confidence in their treatment, assessed on a numerical scale from 0 to 10, measured at Day 0, Month 6 and Month 12.
Time Frame
Change from baseline at Month 6 and Month 12
Title
To compare the effectiveness of adding the program to conventional management alone in terms of patients' level of knowledge about the disease and treatment.
Description
Score obtained in the knowledge quizz conducted in Day 0, then at 2 months. This questionnaire is developed by our team based on Likert scales from 1 to 4.
Time Frame
Change from baseline at Month 2
Title
To compare the effectiveness of adding the program to conventional management alone in terms of patients' satisfaction with their care at Month 12.
Description
Score of satisfaction with patient care in relation to the needs they have had over the past 12 months. This questionnaire is developed by our team based on Likert scales from 0 to 3.
Time Frame
For a year
Title
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.
Description
the cost-utility ratio of the program will be calculated by estimating the costs incurred/avoided by this program and the evolution of the quality of life of the patients at different times.
Time Frame
For a year
Title
To assess patient interest in and adherence to the proposed program in the experimental group.
Description
Refusal rate and program participation rate The rate of premature exit or loss of sight The number and type of workshops attended by patients Evaluation of program content based on Likert scales ranging from 1 to 4.
Time Frame
For a year
Title
To describe the non-drug means used by patients to manage their adverse events.
Description
Patients' non-drug management of side effects and use of supportive care will be recorded.
Time Frame
For a year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Émilie GADEA
Phone
+33 4 71 04 35 38
Email
projetetaph@ch-lepuy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Séverine Breysse
Organizational Affiliation
Centre Hospitalier Emile Roux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Emile Roux
City
Le Puy-en-Velay
ZIP/Postal Code
43000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie Gadea
Email
projetetaph@ch-lepuy.fr
First Name & Middle Initial & Last Name & Degree
Séverine Breysse
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The study sponsor is the owner of the data and no use or transmission to a third party may be made without its prior consent. All information resulting from this clinical research protocol is considered confidential.
Learn more about this trial
Therapeutic Education and Nursing Support Program for Supportive Care, in Patients Treated With Hormone Therapy for Non-metastatic Breast Cancer
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