Coping After Breast Cancer - a Randomized Clinical Trial With Two Digital Interventions
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: Stressproffen cognitive based stress management, Stressproffen mindfulness based intervention, Control.
- Кому может быть актуально
- Состояния в реестре: Breast Cancer Patients, Health, Subjective. Базовые параметры: 20 лет — 69 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
- Норвегия
- 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
Coping After Breast Cancer - CABC - Stressmestring Etter Brystkreft - SEB
Обзор
1. Breast cancer patients and age-matched controls are first invited to answer questions on HRQoL. 2. Among responding breast cancer patients, a subset are invited in a randomized clinical trial with two digital interventions for cancer stress management, cognitive based stress management (CBSM) and mindfulness based intervention (MBI), as well as a control group. 3. The goal is to determine whether digital CBSM or MBI can effectively reduce stress levels as compared to a control group. Second, whether these interventions can improve HRQoL (or avoid onset of HRQoL problems) for patients with breast cancer, compared to a control group.
Подробное описание
After completing the baseline HRQoL assessment, eligible breast cancer patients will be invited to participate in a randomized clinical trial.
Those who are willing will be randomly allocated to one of the following arms: a) Digital cognitive based stress management, b) Digital mindfulness based intervention or c) Control group.
The intervention is based on a revised version of the Stressproffen app, which was developed by the Oslo University Hospital (Lise Solberg Nes, Elin Børøsund and others).
Outcome measures include measures of perceived stress and HRQoL.
Вмешательства
- Другое Stressproffen cognitive based stress management
The participants will download an app (Stressproffen 2A) with cognitive based stress management. - Другое Stressproffen mindfulness based intervention
The participants will download an app (Stressproffen 2B) with mindfulness based intervention. - Другое Control
The participants will receive no app. (They will be able to download it after the end of the 3 year study).
Первичные конечные точки
- Stress [Срок оценки: change from CABC baseline (week 0) to f-up week 21]
Вторичные конечные точки (12)
- Subjective health (HRQoL) [Срок оценки: change from CABC baseline (week 0) to f-up week 21]
- Coping [Срок оценки: change from CABC baseline (week 0) to f-up week 21]
- Anxiety and depression [Срок оценки: change from CABC baseline (week 0) to f-up week 21]
- Fatigue [Срок оценки: change from CABC baseline (week 0) to f-up week 21]
- Mindfulness [Срок оценки: change from CABC baseline (week 0) to f-up week 21]
- Sleep [Срок оценки: change from CABC baseline (week 0) to f-up week 21]
- EORTC QLQ-C30 [Срок оценки: From NBCR baseline to f-up week 20]
- EORTC QLQ-BR23 [Срок оценки: From NBCR baseline to f-up week 20]
- Neuropathy (FACT GOG-NTX and -ES) [Срок оценки: From NBCR baseline to f-up week 20]
- Stress [Срок оценки: change from CABC baseline (week 0) to f-up month 15]
- Subjective health (HRQoL) [Срок оценки: change from CABC baseline (week 0) to f-up month 15]
- Coping [Срок оценки: change from CABC baseline (week 0) to f-up month 15]
Критерии участия
Критерии включения
- first occurrence breast cancer diagnosed from Jan 1, 2020
- non-metastatic cancer stage 0-III
Invasive tumors must be:
- HER2 positive (regardless of ER, PR) or
- ER negative
- (may later include other ER+ if not conflict with recruitment for EMIT/OPTIMA)
Критерии исключения
- None
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
- Профилактика
Центры проведения
Норвегия · 1 центр
- Cancer Registry of Norway — Oslo
Публикации
- Svendsen K, Nes LS, Leithe S, Meland A, Gjelsvik YM, Borosund E, Larsson IM, Myklebust TA, Balto A, Rygg CM, Kiserud CE, Antoni MH, Chalder T, Mjaaland I, Carlson LE, Eriksen HR, Ursin G. Testing two digital stress-management interventions in a randomized controlled trial of breast cancer patients. Sci Rep. 2025 Nov 6;15(1):38966. doi: 10.1038/s41598-025-22889-0. PMID 41198868
- Svendsen K, Nes LS, Meland A, Larsson IM, Gjelsvik YM, Borosund E, Rygg CM, Myklebust TA, Reinertsen KV, Kiserud CE, Skjerven H, Antoni MH, Chalder T, Mjaaland I, Carlson LE, Eriksen HR, Ursin G. Coping After Breast Cancer: Protocol for a Randomized Controlled Trial of Stress Management eHealth Interventions. JMIR Res Protoc. 2023 May 24;12:e47195. doi: 10.2196/47195. PMID 37103493
Идентификаторы
NCT: NCT04480203 · CABC - Kreftfor project - SEB