An interventional study of Therapeutic Education Program for Women With Breast Cancer in Breast Cancer Female NOS, sponsored by Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco. Completed at 1 site in Morocco. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-10.
Sponsored by Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco · Not applicable, Interventional, and Supportive care
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 62 is below the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →This is the only study on the registry with Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco as lead sponsor.
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Exclusion Criteria:
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.
Behavioral: Therapeutic Education Program for Women With Breast Cancer
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.
Change in Sexual Function Score (FSFI)
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.
Time frame: Baseline and 2 months after the intervention
Change in Therapeutic Adherence Score (ARMS-12)
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.
Time frame: Baseline and 2 months after the intervention
Plan to share: No
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Ran from Jan 2026 to primary completion in Apr 2026, 2 months.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's 2 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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