Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

THE IMPACT OF WHATSAPP BASED EX-PLISSIT MODEL SEXUAL COUNSELING ON THE SEXUAL LIVES OF BREAST CANCER SURVIVORS

5 de julio de 2026 actualizado por: Serap Kırıcı, Karamanoğlu Mehmetbey University

THE EFFECT OF WHATSAPP BASED EX-PLISSIT MODEL SEXUAL COUNSELING ON SEXUAL FUNCTION AND SEXUAL DISTRESS IN BREAST CANCER SURVIVORS: A RANDOMIZED CONTROLLED STUDY

Cancer is a significant health problem negatively impacting human health due to population growth, aging, and lifestyle changes known to cause cancer. According to World Health Organization sources, the number of newly diagnosed cancer patients, which was 19.3 million in 2020, is projected to reach 30.2 million in 2040. Breast cancer, the most frequently diagnosed type of cancer in the female population worldwide, has an incidence of 47.8 per 100,000 globally and 47.7 per 100,000 in Turkey, according to 2020 GLOBOCAN data. Surgical treatment, chemotherapy, radiotherapy, and hormonal therapies used in the treatment of breast cancer, which has a high incidence worldwide and causes significant loss of workforce, have become important in altering the course of the disease. However, long-term treatments and related complications negatively affect the sexual functions of individuals. Women and men of reproductive age diagnosed with cancer; Even if they have survived cancer and benefited from curative treatments, they face sexual problems caused by the treatment. Individuals diagnosed with and treated for breast cancer experience difficulties in accessing counseling on issues related to their sexuality.Studies have shown that patients are hesitant to discuss sexual matters, need information about sexual problems during and after cancer treatment, but sexual counseling is not included in oncology care, and healthcare professionals focus more on medical issues. In this context, healthcare professionals can utilize many models for sexual counseling. The use of models in assessing sexual health guides healthcare professionals, facilitates the history-taking process, and helps in identifying sexual problems. The International Society for Research on Women's Sexual Health (ISSWSH) aims to establish a basic methodological strategy for identifying sexual problems in women and considering biological, psychological, sociocultural, and related factors that may cause sexual problems. The use of professional sexual assessment models by nurses in questioning and evaluating patient sexuality will be healthier and more effective. PLISSIT and EX-PLISSIT models are widely used by nurses working in primary care settings to address sexual health needs and concerns.

The PLISSIT model consists of four levels: P - Permission, LI - Limited Information, SS - Specific Suggestions, and IT - Intensive Therapy. As the intervention stages of the PLISSIT model progress, more comprehensive knowledge, training, and skills are required. The Ex-PLISSIT model has been developed as an extension of the PLISSIT model. Ex-PLISSIT is a more expanded version of the PLISSIT model, with the permission stage at its center. One cannot proceed to the next stage without obtaining permission.

Descripción general del estudio

Estado

Activo, no reclutando

Tipo de estudio

Intervencionista

Inscripción (Actual)

86

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Women diagnosed with breast cancer, stage 0, I, or II,
  • Having undergone mastectomy, and at least 6 months having passed since the completion of radiotherapy and chemotherapy treatment,
  • Aged 18-49, not pregnant, not breastfeeding, not menopausal,
  • Women with sexual dysfunction (FSFI score 26.55 or lower), sexually active, married and living with their spouse.

Exclusion Criteria:

  • Women with chronic, psychological, and physical illnesses,
  • Those with alcohol and substance abuse,
  • Those who have previously received education or counseling for sexual dysfunction,
  • Women diagnosed with cancer other than breast cancer

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Otro
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: grupo de control
Experimental: experimental group
Sexual Counseling Based on the EX-PLISSIT Model
Sexual counseling in the intervention group will be conducted according to the 4-stage EX-PLISSIT model. The EX-PLISSIT model will be implemented by the first author (SK), a specialist nurse who completed a PhD in obstetrics and gynecology nursing with a focus on sexuality. Furthermore, the first author (SK) attended a 120-hour Sexual Therapy Training Certificate Program prior to the study. This will be conducted both individually and in a group setting online. Appropriate training packages in the form of video clips, images, and audio recordings will be created by the research team and then shared via WhatsApp. The intervention consists of four counseling sessions, each lasting 30 to 60 minutes, once a week for four weeks. The control group will receive only routine care without any intervention.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Measuring the effect of sexual counseling on sexual function based on the BETTER model.
Periodo de tiempo: one month

After sexual counseling based on the EX-PLISSIT model, the Female Sexual Function Index (FSFI) scale were administered to women in the experimental and control groups via face-to-face interviews. The administration time for each scale varied between 15 and 20 minutes.

Changes in the Female Sexual Function Index (FSFI) scale were measured two months after sexual counseling based on the BETTER model.

Female Sexual Function Index (FSFI) It was developed by Rosen et al. as a multidimensional scale comprising 19 items to evaluate female sexual function. The scale includes six subheadings, desire, arousal, lubrication, orgasm, satisfaction, and pain. Each title was scored between 0 or 1 and six. The lowest and highest scores are 2 and 36, respectively. Higher scores indicated better sexual function. The cut-off value of the scale was 26.55. A total FSFI score of ≤26.55, it indicates sexual dysfunction

one month

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Measuring the effect of sexual counseling on sexual distress based on the BETTER model
Periodo de tiempo: one month

After sexual counseling based on the EX-PLISSIT model, the Female Sexual Distress Scale-Revised (FSDS-R) scale were administered to women in the experimental and control groups via face-to-face interviews. The administration time for each scale varied between 15 and 20 minutes.

Changes in the Female Sexual Distress Scale-Revised (FSDS-R) scale were measured one months after sexual counseling based on the BETTER model.

Female Sexual Distress Scale-Revised (FSDS-R) Developed by Derogatis et al. (2008) to measure personal distress related to sexuality in women. The FSDS-R is a 13-item, 5-point Likert-type scale where items are scored on a 0-4 scale. The minimum score that can be obtained from the FSDS-R is "0", and the maximum score is "52". A higher score indicates a higher level of sexual distress. The cutoff point of the scale is 11.5. A score of 11.5 ≥ indicates the presence of sexual distress.

one month

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de marzo de 2026

Finalización primaria (Estimado)

1 de julio de 2026

Finalización del estudio (Estimado)

1 de agosto de 2026

Fechas de registro del estudio

Enviado por primera vez

30 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de mayo de 2026

Publicado por primera vez (Actual)

4 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

7 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

5 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • DECISION 02-2026/44

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir