Every Day Counts: A Lifestyle Program for Women With Metastatic Breast Cancer
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: Lifestyle Intervention, Attention Control.
- Кому может быть актуально
- Состояния в реестре: Metastatic Breast Cancer. Базовые параметры: от 18 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
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This multi-site study is being conducted to examine dietary and activity patterns, body composition, blood and quality of life in breast cancer patients. The study will recruit 176 women with MBC in Milwaukee (n=88) and Chicago (n=88).
Подробное описание
Aims/Objectives
Aim 1. To examine the efficacy of the Every Day Counts intervention in producing significant post-intervention changes in multidimensional QOL in women with MBC.
Hypothesis 1: Women randomized to the immediate EDC intervention (n=88) will exhibit greater improvements in multidimensional QOL compared to women randomized to the attention control (n=88).
Aim 2. To investigate the mechanistic effects of the Every Day Counts intervention on body composition, adipokines, serum biomarkers of inflammation and insulin sensitivity.
Hypothesis 2: The EDC intervention leads to improved QOL through mediating factors including body composition, prognostic serum biomarkers of inflammation and/or insulin resistance.
Exploratory Aim 3: To explore if microRNA (miRNA) signatures associated with inflammation and/or Metabolomics are altered with the EDC intervention.
Hypothesis: miRNAs identified in our pilot study (miR-10a-5p, miR-205-5p, and miR-211-5p) that regulate inflammation and/or Metabolomics will be related to QOL improvements and can identify women more likely to respond to lifestyle changes.
Вмешательства
- Поведенческое Lifestyle Intervention
The lifestyle intervention is a 16-week cognitive-behavioral intervention that addresses key changes in diet and PA behaviors to promote positive body composition changes. - Поведенческое Attention Control
The attention control participants will receive a home/work organization intervention: Following completion of the attention control home/work organization program and 16-week assessment, women will receive the lifestyle program.
Первичные конечные точки
- Intervention adherence [Срок оценки: 4 months]
- Intervention retention [Срок оценки: 4 months]
- Intervention retention [Срок оценки: 8 months]
- Change in Quality of Life [Срок оценки: Change from baseline to 4 months]
- Change in Quality of Life [Срок оценки: change from baseline to 8 months]
- Body composition [Срок оценки: change from baseline to 4 months]
- Body composition [Срок оценки: change from baseline to 8 months]
Вторичные конечные точки (8)
- Serum Biomarker Inflammation - C-Reactive Protein [Срок оценки: Change from baseline to 4 month]
- Serum Biomarker Insulin Resistance - Insulin [Срок оценки: Change from baseline to 4 month]
- Serum Biomarker Insulin Resistance- Glucose [Срок оценки: Change from baseline to 4 month]
- Serum Biomarker Inflammation - Tumor Necrosis Factor - alpha [Срок оценки: Change from baseline to 4 month]
- Serum Biomarker Insulin Resistance- C-Peptide [Срок оценки: Change from baseline to 4 month]
- Serum Biomarker Adipokine Dysregulation - Adiponectin [Срок оценки: Change from baseline to 4 month]
- Serum Biomarker Adipokine Dysregulation - Leptin [Срок оценки: Change from baseline to 4 month]
- Serum Biomarker Inflammation - Interleukin 6 [Срок оценки: Change from baseline to 4 month]
Критерии участия
Критерии включения
- Adult (≥ 18 years), female
- Confirmed Metastatic Breast Cancer
- Patients clinically stable with treated brain metastases are eligible
- Written documentation from their oncologist permitting study participation
- Determined to be "clinically stable" by their medical oncologist (i.e., no unintentional weight loss, no new symptoms or change in performance status for the past 4 weeks, no clinical \[including laboratory\] or radiologic evidence of disease progression, no recent or planned change in anti-neoplastic therapies, no reports of severe pain \[≥ Grade 3 per the NCI CTCAE)
- Life expectancy >6 months
-Written documentation from their oncologist permitting study participation
- Access to a mobile phone
- Understand/speak English fluently.
- Non-adherence to ACS nutritional or PA guidelines for cancer survivors as documented by questionnaire.
Критерии исключения
- Does not meet the above criteria.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Поддерживающая терапия
Центры проведения
США · 2 центра
- Loyola University — Maywood
- Medical College of Wisconsin — Milwaukee
Идентификаторы
NCT: NCT03824145 · 27600