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Идёт набор NCT05642897

Mind Programme for Women With Breast Cancer

Без фазы С лечением Breast Cancer Female

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Mind, Support Group.
Кому может быть актуально
Состояния в реестре: Breast Cancer Female. Базовые параметры: 18 лет — 70 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Португалия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Mind Programme for Women With Breast Cancer: A Randomized Controlled Trial Testing the Programme´s Cost-effectiveness and Efficacy in Changing Psychological and Biological Outcomes

Обзор

The Mind programme for cancer patients was developed by this project PI through the integration of ACT, mindfulness and CFT components specifically adapted to the needs of a cancer population. This intervention aims at improving well-being, preventing subsequent distress, and promoting adaptation to the disease and posttreatment period. A recent pilot study presented preliminary findings on this intervention, suggesting high acceptability and efficacy in improving self-reported psychological health in breast cancer patients undergoing Radiotherapy treatment. Nevertheless, this study's small sample size, methodology (inactive control group), and exclusive reliance on self-reported data limit the interpretation and generalization of results, creating an avenue for the optimization and further testing of the programme through more robust and reliable methods. The aim of this project is therefore to optimize the Mind programme taking into consideration the results from its pilot study and to conduct a Randomized Controlled Trial on the efficacy of the intervention in improving not only mental health outcomes but also biological markers, as well as on its cost-effectiveness, in women with breast cancer. The superiority of the Mind programme will be compared to a support group intervention through the analysis of changes in cancer-specific quality of life, depressive symptoms and anxiety severity, psychological experiences, and immunological and epigenetics markers related to mental health and breast cancer prognosis. All participants will receive the intervention that shows better results.

Вмешательства

  • Поведенческое Mind
    ACT, mindfulness, and compassion-based intervention
  • Поведенческое Support Group
    This intervention promotes the sharing of cancer-related experiences, active listening and a sense of community between participants.

Первичные конечные точки

  • Cancer-specific quality of life [Срок оценки: Baseline, post-treatment (2 months after baseline), and 6-months follow-up]
Вторичные конечные точки (8)
  • Psychological flexibility [Срок оценки: Baseline, post-treatment (2 months after baseline), and 6-months follow-up]
  • Self-compassion and mindfulness [Срок оценки: Baseline, post-treatment (2 months after baseline), and 6-months follow-up]
  • Immunological and epigenetic markers [Срок оценки: Baseline, post-treatment (2 months after baseline) and 6-months follow-up]
  • General quality of life [Срок оценки: Baseline, post-treatment (2 months after baseline), and 6-months follow-up]
  • Major life events questionnaire - controlling variable [Срок оценки: 6-months follow-up]
  • ACT processes (Hexa(in)Flex Interview) [Срок оценки: Baseline]
  • Consumption of resources and costs [Срок оценки: Baseline, post-treatment (2 months after baseline), and 6-months follow-up]
  • Depressive symptoms and anxiety severity [Срок оценки: Baseline, post-treatment (2 months after baseline), and 6-months follow-up]

Критерии участия

Критерии включения

  • age between 18-70;
  • primary diagnosis of BC (stages between I and III);
  • undergoing radiotherapy treatment at CHUC;
  • able to understand and answer to self-report questionnaires in Portuguese.

Критерии исключения

  • currently undergoing any form of psychological intervention;
  • current diagnosis of severe psychiatric illness (psychotic disorder, bipolar disorder, substance abuse, and personality disorder) or suicidal ideation;
  • diagnosis of neurological disease.

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
Двойное слепое
Основная цель
Лечение

Центры проведения

Португалия · 1 центр
  • Radiotherapy Service of the Coimbra University Hospital (CHUC) — Coimbra

Публикации

  • Trindade IA, Soares A, Skvarc D, Carreiras D, Pereira J, Lourenco O, Sampaio F, de Sousa B, Martins TC, Boaventura P, Marta-Simoes J; Mind Project Team; Moreira H. Efficacy and cost-effectiveness of an ACT and compassion-based intervention for women with breast cancer: study protocol of two randomised controlled trials 1. Trials. 2025 Jan 3;26(1):5. doi: 10.1186/s13063-024-08626-4. PMID 39754194

Идентификаторы

NCT: NCT05642897 · CINEICC-3-IAT

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗