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Completed

NCT Number: NCT07367074

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Medical Oncology Department, Ibn Tofail Hospital, Mohammed VI University Hospital Center

Marrakesh, Marrakesh-Safi, Morocco

About this study

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. In addition, participants will benefit from supportive follow-up through a moderated WhatsApp group designed to reinforce educational messages, facilitate experience sharing among participants, and provide ongoing support throughout the intervention period.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Therapeutic Education Program for Women With Breast Cancer

Behavioral

This 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 Palliative Care, followed by supportive follow-up through a WhatsApp group that enables participants to share experiences, receive educational reinforcement, and discuss concerns related to treatment and sexual health. 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.

Primary outcomes

  1. Change in Sexual Function Score (FSFI)

    Time frame: Baseline and 2 months after the intervention

    Sexual function will be assessed using the Female Sexual Function Index (FSFI), a validated questionnaire with a total score ranging from 2 to 36, where higher scores indicate better sexual function.

    The primary outcome will be the change in the total FSFI score between baseline and two months after the educational intervention.

Secondary outcomes

  1. Change in Therapeutic Adherence Score (ARMS-12)

    Time frame: Baseline and 2 months after the intervention

    Therapeutic adherence will be assessed using the Adherence to Refills and Medications Scale (ARMS-12), a validated questionnaire with a total score ranging from 12 to 48, where lower scores indicate better medication adherence.

    The secondary outcome will be the change in the total ARMS-12 score between baseline and two months after the educational intervention.

Sponsors and collaborators

Lead sponsor

Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco

Other

Registry information

Official study title

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

Acronym: EDU-INT-BC

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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