Clinical Trials Directory

Trials / Recruiting

RecruitingNCT07367074

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

Effect of an Educational Intervention on Sexual Function and Therapeutic Adherence in Women With Breast Cancer

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
65 (estimated)
Sponsor
Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALTherapeutic Education Program for Women With Breast CancerThis intervention will consist of a structured therapeutic education program designed for women with breast cancer. The program will focus on disease-related information, treatment modalities and their associated side effects, sexual function, and strategies to improve therapeutic adherence. The intervention will include two face-to-face educational sessions, each lasting two hours, delivered by a midwife enrolled in the final semester of a Master's program in advanced practices in oncology and Palliatives Cares, followed by supportive follow-up via WhatsApp to reinforce key messages and address participants' concerns. The educational content will be adapted to participants' needs and health literacy levels. Outcomes related to sexual function and treatment adherence will be assessed before the intervention and two months after its implementation.

Timeline

Start date
2026-01-26
Primary completion
2026-04-01
Completion
2026-04-01
First posted
2026-01-26
Last updated
2026-03-03

Locations

1 site across 1 country: Morocco

Source: ClinicalTrials.gov record NCT07367074. Inclusion in this directory is not an endorsement.