Effect of an Educational Intervention in Women With Breast Cancer (EDU-INT-BC)

Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco

Status: Not yet enrolling

Conditions: Breast Cancer Female NOS

Treatments: Behavioral: Therapeutic Education Program for Women With Breast Cancer

Study type: Interventional

Funder types: Other

Identifiers

NCT07367074

ISPITS-PAOSP-EDU-INT-BC-2025

Details and patient eligibility

About

This study aims to evaluate the effect of an educational intervention on sexual function and therapeutic adherence among women with breast cancer followed in the medical oncology department of Ibn Tofail Hospital, affiliated with Mohammed VI University Hospital Center in Marrakech.

Participants will receive a structured therapeutic education program focusing on breast cancer, available treatments and their potential side effects, as well as treatment adherence and its prognostic significance. Educational sessions will be complemented by patient follow-up to reinforce key messages and support adherence.

The study will assess changes in sexual function and therapeutic adherence before and after the educational intervention.

Full description

This is an interventional study without a control group aiming to evaluate the effect of an educational intervention on sexual function and therapeutic adherence among women with breast cancer followed in the medical oncology department of Ibn Tofail Hospital, affiliated with the Mohammed VI University Hospital Center (CHU) in Marrakech.

Methodology: Participants will be recruited among women aged over 18 years, diagnosed with breast cancer, receiving oral anticancer treatment, and willing to participate in the study. Sociodemographic and clinical data will be collected through interviews with the participants and by reviewing their medical records.

Intervention: The therapeutic education program will consist of two sessions conducted by a midwife experienced in breast and cervical cancer screening, enrolled in the final semester of the Master's program in Advanced Practice in Oncology and Palliative Care at ISPITS Marrakech. The sessions will address topics such as breast cancer, available treatments and their role, treatment-related effects on sexual function, as well as the importance of therapeutic adherence and behavioral coping strategies.

Evaluations: Outcomes will be assessed using validated questionnaires to evaluate sexual function and therapeutic adherence. The questionnaires will be administered before the intervention and two months after the educational intervention in order to assess changes in sexual function and therapeutic adherence among participants.

Ethical Considerations: The study will comply with all ethical principles, including obtaining informed consent and ensuring the participants' right to withdraw from the study at any time. The intervention has already received approval from the ethics committee and will also be approved by a research professor and a permanent faculty member trained in therapeutic education at ISPITS, as well as by a medical oncology professor at Mohammed VI University Hospital Center in Marrakech, prior to its implementation.

Data Analysis: Data will be analyzed using SPSS software. For variables not following a normal distribution, non-parametric statistical tests will be applied.

Enrollment: 65 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women aged 18 years and older.
• Diagnosed with breast cancer.
• Receiving oral anticancer treatment.
• Willing to participate in the study.
• Able to attend the educational sessions.
• Having access to a mobile phone (smartphone).

Exclusion criteria

• Women with communication disorders.
• Women with severe psychiatric disorders that will interfere with participation in the educational intervention.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Educational Intervention Arm

Experimental group

Description:

Participants assigned to this arm will receive a structured educational intervention focusing on breast cancer, treatment-related side effects, sexual health, and therapeutic adherence. The intervention consists of two educational sessions of two hours each, followed by follow-up support via WhatsApp. Outcomes will be assessed before the intervention and two months after its implementation.

Treatment:

Behavioral: Therapeutic Education Program for Women With Breast Cancer