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

NCT07367074 | Recruiting

• 1 other identifier: ISPITS-PAOSP-EDU-INT-BC-2025
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Female NOS

Keywords

Breast cancer; Educational intervention; Sexual function; Therapeutic adherence

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 2 months after the intervention

Secondary Outcomes (1)

• Change in Therapeutic Adherence Score (ARMS-12)

  Baseline and 2 months after the intervention

Study Arms (1)

Educational Intervention Arm

EXPERIMENTAL

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

Interventions

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 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.

Educational Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study will be restricted to women diagnosed with breast cancer.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco: lead

Study Sites (1)

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

Marrakesh, Marrakech-Safi, Morocco

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Health Behavior; Behavior

Central Study Contacts

Safa LAAMARI, Master Student

CONTACT

+212661706515; laamarisafa92@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master's student in advanced practices in oncology and palliative care

Model Details: This is a single-group interventional study with a pre-post design, in which all participants receive the same educational intervention.

Study Record Dates

• First Submitted: January 17, 2026
• First Posted: January 26, 2026
• Study Start: January 26, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: March 3, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

MO (1)