Psychoeducation and Well-Being After Breast Cancer

Официальное название

The Effect of a Web-Based Supportive Psychoeducation Program on Psychological Well-Being, Quality of Life and Fear of Recurrence Applied to Patients Who Completed Active Breast Cancer Treatment

Обзор

This randomized controlled trial evaluates the effectiveness of a web-based psychoeducation program on psychological well-being and quality of life in breast cancer survivors who completed active treatment at least one year earlier. Seventy-two women will be randomly assigned to either a 6-week online psychoeducation program plus standard care or standard care alone. The intervention consists of weekly 30-45 minute online sessions focusing on coping strategies, psychosocial adjustment, quality of life, and psychological well-being. Primary outcomes include psychological well-being, fear of cancer recurrence, quality of life, and hopelessness, assessed at baseline, post-intervention, and 2-month follow-up.

Подробное описание

This randomized controlled study investigates the effects of a structured web-based psychoeducation program on psychological outcomes in breast cancer survivors who have completed active treatment and are in remission for at least one year.

Eligible participants will be randomly allocated to an intervention group or a control group. The intervention group will receive a 6-week web-based psychoeducation program in addition to standard care, while the control group will receive standard care alone. The program is delivered through the online platform www.onkodestek.org and includes weekly live sessions conducted via Zoom, each lasting approximately 30-45 minutes.

The psychoeducation program addresses coping with breast cancer survivorship, psychosocial challenges, enhancement of psychological well-being, improvement of quality of life, and development of hope and meaning in life.

Psychological well-being, fear of cancer recurrence, quality of life, and hopelessness will be assessed at baseline, immediately after the intervention, and at 2-month follow-up using validated self-report measures. After study completion, participants in the control group will be granted access to the psychoeducation platform.

This study aims to assess whether web-based psychoeducation provides measurable psychological benefits for breast cancer survivors during the post-treatment survivorship period.

Вмешательства

• Поведенческое Web-Based Psychoeducation Program
  Six-week structured psychoeducation program delivered online through www.onkodestek.org website and weekly Zoom sessions. Topics include living with breast cancer, managing psychosocial issues, improving quality of life, psychological well-being, and finding hope and meaning. Each session lasts 30-45 minutes.

Первичные конечные точки

• Change in Psychological Well-Being [Срок оценки: Baseline, 6 weeks (post-intervention), and 2-month follow-up]
• Change in Fear of Cancer Recurrence [Срок оценки: Baseline, 6 weeks (post-intervention), and 2-month follow-up]

Вторичные конечные точки (3)

• Change in Cancer-Related Quality of Life [Срок оценки: Baseline, 6 weeks, and 2-month follow-up]
• Change in Hopelessness [Срок оценки: Baseline, 6 weeks, and 2-month follow-up]
• Change in Breast Cancer-Specific Quality of Life [Срок оценки: Baseline, 6 weeks, and 2-month follow-up]

Критерии участия

Критерии включения

• Female breast cancer survivors
• Completed active breast cancer treatment (surgery, chemotherapy, radiotherapy) at least 12 months ago
• Currently in remission (no evidence of active disease)
• Age between 18-65 years
• Able to read and write Turkish
• Access to computer or smartphone with internet connection
• Able to participate in online video sessions via Zoom
• Willing to provide informed consent

Критерии исключения

• Current cancer recurrence or metastatic disease
• Active psychiatric disorder requiring treatment
• Cognitive impairment that prevents participation in online sessions
• Currently receiving active cancer treatment (excluding hormonal therapy)
• Participation in another psychosocial intervention study
• No internet access or inability to use web-based platforms
• Male breast cancer patients
• Unable to commit to 6-week program schedule

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Breast Cancer Outpatient Clinic — Istanbul

Публикации

• Karsten MM, Roehle R, Albers S, Pross T, Hage AM, Weiler K, Fischer F, Rose M, Kuhn F, Blohmer JU. Real-world reference scores for EORTC QLQ-C30 and EORTC QLQ-BR23 in early breast cancer patients. Eur J Cancer. 2022 Mar;163:128-139. doi: 10.1016/j.ejca.2021.12.020. Epub 2022 Jan 20. PMID 35066338
• Mateu P, Teixidor-Batlle C, Suarez-Alcazar MP, Salas-Medina P, Catala-Vilaplana I, Hernando-Domingo C, Muriach M, Collado-Boira E. A qualitative case study of body image in women with breast cancer participating in an exercise program. Support Care Cancer. 2025 Oct 1;33(10):893. doi: 10.1007/s00520-025-09963-z. PMID 41032141

Идентификаторы

NCT: NCT07284030 · UskudarU 22.07.2024

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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