Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer II) (BEAT)
13 октября 2021 г. обновлено: Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer Study II)
The purpose of the study is to compare the effects of one exercise/counseling protocol with usual care on long term exercise adherence and on changes in health related outcomes after breast cancer diagnosis.
Обзор исследования
Статус
Завершенный
Условия
Подробное описание
Physical activity may improve quality of life, the control of comorbid conditions, and weight management while reducing breast cancer recurrence and mortality among breast cancer survivors. Unfortunately, most breast cancer survivors do not engage in regular physical activity. In fact, breast cancer survivors are often less active after a diagnosis and may not return to pre-diagnosis activity levels. Therefore, we conducted a pilot study, "BEAT Cancer", to test a specifically defined physical activity behavior change intervention to increase physical activity for breast cancer survivors. The pilot study showed significant improvement in both physical activity and health outcomes for the study participants after the intervention. Importantly, the pilot intervention resulted in changes in physical activity and social cognitive theory constructs, such as the participants feeling more confident in their ability to exercise. The positive results enhance our potential for testing mechanisms that encourage physical activity behavior change in breast cancer survivors. The current study is a follow-up to confirm program effectiveness at 3 months and to test sustainability of results at 3-12 months. We propose a multi-center, randomized controlled trial enrolling 356 breast cancer survivors with the following study aims:
- To compare the effects of the 3-month BEAT Cancer physical activity behavior change intervention to usual care on short and longer term physical activity adherence among breast cancer survivors. We hypothesize that, compared with usual care, the intervention will result in a significant increase in physical activity after the intervention that will be maintained up to 12 months after baseline.
- To better understand the reasons why breast cancer patients change their physical activity behavior, we will compare the effects of the BEAT Cancer physical activity behavior change intervention to usual care on social cognitive factors to see if such changes contribute to physical activity behavior change. We hypothesize that, compared with usual care, the intervention will result in significant improvements in social cognitive factors which lead to changes in physical activity behavior.
- We also aim to compare the short and longer term health effects of the BEAT Cancer physical activity behavior change intervention when compared with usual care. We hypothesize that, compared with usual care, the intervention will result in significant improvements in fitness, muscle strength, waist-to-hip ratio, quality of life, fatigue, and sleep quality, while reducing joint dysfunction.
Тип исследования
Интервенционный
Регистрация (Действительный)
374
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Alabama
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Birmingham, Alabama, Соединенные Штаты, 35294
- University of Alabama at Birmingham
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Illinois
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Champaign, Illinois, Соединенные Штаты, 61801
- University of Illinois
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Springfield, Illinois, Соединенные Штаты, 62702
- Southern Illinois University School of Medicine
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
От 18 лет до 70 лет (Взрослый, Пожилой взрослый)
Принимает здоровых добровольцев
Нет
Полы, имеющие право на обучение
Женский
Описание
Inclusion Criteria:
- Female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of ductal carcinoma in situ (DCIS) or Stage I, II, or IIIA breast cancer and who are not currently receiving (and do not plan to receive during the duration of the study) chemotherapy or radiation therapy. The participant may be taking longer term therapies such as aromatase inhibitors, estrogen receptor modulators, etc. The upper age limit of 70 years was chosen to reduce the likelihood of adverse events or study drop-out due to increasing comorbidities (e.g., cardiovascular disease) that occur with age.
- If the patient has undergone a surgical procedure, enrollment will be delayed until ≥ 8 weeks post-procedure.
- English speaking.
- Medical clearance for participation provided by primary care physician or oncologist.
- Participating, on average, in no more than 60 minutes of moderate physical activity or no more than 30 minutes of vigorous activity per week during the past six months.
Exclusion Criteria:
- Diagnosis of dementia or organic brain syndrome.
- Medical, psychological, or social characteristic that would interfere with ability to fully participate in program activities and assessments (e.g., psychosis, schizophrenia, etc.).
- Contraindication to participation in a regular physical activity program.
- Metastatic or recurrent disease.
- Inability to ambulate.
- Anticipates undergoing elective surgery during the duration of the intervention which would interfere with intervention participation (e.g., breast reconstructive surgery).
- Planned travel that would interfere with scheduled study sessions (no travel in the 1st 4 months and no travel ≥ 1 week in the last 8 weeks of the intervention).
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: 1: exercise with 2 counseling types
Patients will participate in 12 individual exercise sessions with an exercise specialist; plus attend 6 discussion group sessions with a trained facilitator; plus 3 face-to-face, individual counseling sessions with an exercise specialist
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Patients will participate in 12 individual exercise sessions with an exercise specialist which will include stretching exercises and aerobic treadmill walking; plus attend 6 discussion group sessions with a trained facilitator; plus 3 face-to-face, individual counseling sessions with an exercise specialist
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Другой: 2. Usual Care - written materials
Patients will receive written materials about exercise for cancer survivors
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Patients will receive written materials about exercise for cancer survivors
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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change in physical activity
Временное ограничение: baseline to 3 months
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Physical activity will be measured with accelerometers and self-report questionnaire.
Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).
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baseline to 3 months
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change in physical activity
Временное ограничение: 3 mos to 6 months
|
Physical activity will be measured with accelerometers and self-report questionnaire.
Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).
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3 mos to 6 months
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change in physical activity
Временное ограничение: 6 months to 12 months
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Physical activity will be measured with accelerometers and self-report questionnaire.
Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).
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6 months to 12 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
change in treadmill fitness
Временное ограничение: baseline, 3 months, 6 months, 12 months
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Treadmill fitness will be measured by sub-maximal fitness test.
Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).
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baseline, 3 months, 6 months, 12 months
|
|
change in waist-to-hip ratio
Временное ограничение: baseline, 3 months, 6 months, 12 months
|
Waist-to-hip ratio will be measured with a tape measure.
Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).
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baseline, 3 months, 6 months, 12 months
|
|
change in 3-day dietary intake
Временное ограничение: baseline, 3 months, 6 months, 12 months
|
3-day dietary intake will be measured by questionnaire.
Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).
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baseline, 3 months, 6 months, 12 months
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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Energy expenditure (doubly labeled water)
Временное ограничение: baseline, 3 months, and 6 months
|
Doubly labeled water results will be used to determine reliability of accelerometer measures as part of an NCI funded supplement.
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baseline, 3 months, and 6 months
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Соавторы
Следователи
- Главный следователь: Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- Rogers LQ, Hopkins-Price P, Vicari S, Markwell S, Pamenter R, Courneya KS, Hoelzer K, Naritoku C, Edson B, Jones L, Dunnington G, Verhulst S. Physical activity and health outcomes three months after completing a physical activity behavior change intervention: persistent and delayed effects. Cancer Epidemiol Biomarkers Prev. 2009 May;18(5):1410-8. doi: 10.1158/1055-9965.EPI-08-1045. Epub 2009 Apr 21.
- Rogers LQ, Hopkins-Price P, Vicari S, Pamenter R, Courneya KS, Markwell S, Verhulst S, Hoelzer K, Naritoku C, Jones L, Dunnington G, Lanzotti V, Wynstra J, Shah L, Edson B, Graff A, Lowy M. A randomized trial to increase physical activity in breast cancer survivors. Med Sci Sports Exerc. 2009 Apr;41(4):935-46. doi: 10.1249/MSS.0b013e31818e0e1b.
- Rogers LQ, Markwell SJ, Verhulst S, McAuley E, Courneya KS. Rural breast cancer survivors: exercise preferences and their determinants. Psychooncology. 2009 Apr;18(4):412-21. doi: 10.1002/pon.1497.
- Rogers LQ, Courneya KS, Verhulst S, Markwell SJ, McAuley E. Factors associated with exercise counseling and program preferences among breast cancer survivors. J Phys Act Health. 2008 Sep;5(5):688-705. doi: 10.1123/jpah.5.5.688.
- Rogers LQ, McAuley E, Courneya KS, Verhulst SJ. Correlates of physical activity self-efficacy among breast cancer survivors. Am J Health Behav. 2008 Nov-Dec;32(6):594-603. doi: 10.5555/ajhb.2008.32.6.594.
- Rogers LQ, Markwell S, Hopkins-Price P, Vicari S, Courneya KS, Hoelzer K, Verhulst S. Reduced barriers mediated physical activity maintenance among breast cancer survivors. J Sport Exerc Psychol. 2011 Apr;33(2):235-54. doi: 10.1123/jsep.33.2.235.
- Rogers LQ, McAuley E, Anton PM, Courneya KS, Vicari S, Hopkins-Price P, Verhulst S, Mocharnuk R, Hoelzer K. Better exercise adherence after treatment for cancer (BEAT Cancer) study: rationale, design, and methods. Contemp Clin Trials. 2012 Jan;33(1):124-37. doi: 10.1016/j.cct.2011.09.004. Epub 2011 Sep 29.
- Rogers LQ, Courneya KS, Anton PM, Hopkins-Price P, Verhulst S, Vicari SK, Robbs RS, Mocharnuk R, McAuley E. Effects of the BEAT Cancer physical activity behavior change intervention on physical activity, aerobic fitness, and quality of life in breast cancer survivors: a multicenter randomized controlled trial. Breast Cancer Res Treat. 2015 Jan;149(1):109-19. doi: 10.1007/s10549-014-3216-z. Epub 2014 Nov 23.
- Ainsworth MC, Pekmezi D, Bowles H, Ehlers D, McAuley E, Courneya KS, Rogers LQ. Acceptability of a Mobile Phone App for Measuring Time Use in Breast Cancer Survivors (Life in a Day): Mixed-Methods Study. JMIR Cancer. 2018 May 14;4(1):e9. doi: 10.2196/cancer.8951.
- Rogers LQ, Courneya KS, Anton PM, Hopkins-Price P, Verhulst S, Robbs RS, Vicari SK, McAuley E. Social Cognitive Constructs Did Not Mediate the BEAT Cancer Intervention Effects on Objective Physical Activity Behavior Based on Multivariable Path Analysis. Ann Behav Med. 2017 Apr;51(2):321-326. doi: 10.1007/s12160-016-9840-6.
Полезные ссылки
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования
1 июня 2009 г.
Первичное завершение (Действительный)
1 марта 2017 г.
Завершение исследования (Действительный)
1 марта 2017 г.
Даты регистрации исследования
Первый отправленный
26 июня 2009 г.
Впервые представлено, что соответствует критериям контроля качества
26 июня 2009 г.
Первый опубликованный (Оценивать)
29 июня 2009 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
21 октября 2021 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
13 октября 2021 г.
Последняя проверка
1 октября 2021 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- ROG-SCCI 09-003-2
- 3R01CA136859-02S1 (Грант/контракт NIH США)
- U01CA136859 (Грант/контракт NIH США)
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .