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临床试验/NCT07367074
NCT07367074已完成不适用

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

Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2026年1月26日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
62
试验地点
1
主要终点
Change in Sexual Function Score (FSFI)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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).

排除标准

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

研究组 & 干预措施

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.

干预措施: Therapeutic Education Program for Women With Breast Cancer (Behavioral)

结局指标

主要结局

Change in Sexual Function Score (FSFI)

时间窗: 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.

次要结局

  • Change in Therapeutic Adherence Score (ARMS-12)(Baseline and 2 months after the intervention)

研究者

发起方
Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco
申办方类型
Other
责任方
Principal Investigator
主要研究者

LAAMARI Safa

Master's student in advanced practices in oncology and palliative care

Instituts Supérieurs des Professions Infirmières et Techniques de Santé, Morocco

研究点 (1)

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