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

February 28, 2026 updated by: LAAMARI Safa, Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Morocco
    • Marrakech-Safi
      • Marrakesh, Marrakech-Safi, Morocco
        • Recruiting
        • Medical Oncology Department, Ibn Tofail Hospital, Mohammed VI University Hospital Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Educational Intervention Arm
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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 2 months after the intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 2 months after the intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2026

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

January 17, 2026

First Submitted That Met QC Criteria

January 17, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISPITS-PAOSP-EDU-INT-BC-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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