Lifestyle Behavioural Intervention on Breast Cancer Survivors for the Treatment of Overweight/Obesity.
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: Behavioural Lifestyle (BL).
- Кому может быть актуально
- Состояния в реестре: Breast Cancer Female, Overweight and Obesity. Базовые параметры: 18 лет — 65 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
- Греция
- 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
Design, Implementation and Evaluation of a Behavioural Intervention to Treat Obesity in Breast Cancer Survivors.
Обзор
The goal of this clinical trial is to compare a behavioural lifestyle intervention program (BL) to usual care (UC) in breast cancer survivors. The main questions it aims to answer are: 1. If the participants of the BL group will lose more weight than the UC group. 2. If the participants of the BL group will have more lifestyle benefits than the UC group. Volunteers will participate in a 24-week behavioural program. This program aims to improve their nutrition and physical activity in order to lose at least 10% of their initial body weight.
Подробное описание
Eligible participants should be female breast cancer survivors between the ages of 18 and 65, with a BMI between 25 and 40 kg/m2, and no active cancer therapy or ongoing treatment, except for hormonal or immune therapy.
The usual care (UC) group will receive WCRF cancer prevention recommendations. The behavioural lifestyle intervention program (BL) group will participate in a 24-week intervention targeting diet and physical activity to lose weight.
The program will be considered successful if participants lose at least 10% of their initial body weight. A secondary goal is to improve their nutrition and physical activity levels. The third and last goal is to improve their overall quality of life and their anxiety levels.
The behavioral program includes in-person online meetings, group online sessions, and digital counseling material. Considering that participants will be residing all around Greece, an internet videoconferencing technology will be required.
A qualitative study incorporating focus groups undertaken prior to this study to establish the methodology resulted in the utilization of synchronous and asynchronous media, as well as a combination of in-person and group sessions.
Вмешательства
- Поведенческое Behavioural Lifestyle (BL)
24-week behavioural lifestyle intervention
Первичные конечные точки
- body weight change [Срок оценки: From enrollment to the end of treatment at 24 weeks]
Критерии участия
Критерии включения
- BMI between 25 and 40 kg/m2
Критерии исключения
- active cancer or any ongoing treatment except hormonal or immune therapy
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Простое слепое
- Основная цель
- Лечение
Центры проведения
Греция · 1 центр
- University of Thessaly — Trikala
Публикации
- Perperidi M, Saliari D, Christakis C, Huybrechts I, Saloustros E, Theodorakis Y, Androutsos O. Identifying the effective behaviour change techniques in nutrition and physical activity interventions for the treatment of overweight/obesity in post-treatment breast cancer survivors: a systematic review. Cancer Causes Control. 2023 Aug;34(8):683-703. doi: 10.1007/s10552-023-01707-w. Epub 2023 May 6. PMID 37149509
- Perperidi M, Saltaouras G, Konstandis A, De Craemer M, Saloustros E, Theodorakis Y, Androutsos O. Barriers and facilitators of healthy lifestyle and perspectives towards the development of weight loss programmes. Focus groups with post-treatment breast cancer survivors in Greece. J Nutr Sci. 2023 Nov 3;12:e111. doi: 10.1017/jns.2023.94. eCollection 2023. PMID 37964978
- Saltaouras G, Perperidi M, Vantzou D, Vatsina K, Saloustros E, Theodorakis Y, Androutsos O. Determinants of lifestyle and body weight status among breast cancer survivors with overweight/obesity and perspectives towards the development of weight loss interventions: a qualitative study with health professionals from Greece. J Nutr Sci. 2024 Jan 23;13:e4. doi: 10.1017/jns.2023.117. eCollection 2024. PMID 38282654
Идентификаторы
NCT: NCT06577545 · Behavioral Intervention in BCS