Эта страница была переведена автоматически, точность перевода не гарантируется. Пожалуйста, обратитесь к английской версии для исходного текста.

Impact of Weight Loss Interventions for Overweight Breast Cancer Survivors (VCC0910)

14 января 2013 г. обновлено: Kim Dittus, University of Vermont

Obesity is an epidemic and the majority of breast cancer survivors are overweight or obese. The American Cancer Society has called for weight loss treatment to be standard of care for overweight women with breast cancer. During therapy women with breast cancer often gain weight and lose lean muscle mass. Overweight breast cancer survivors are more likely to have their cancer come back. The reason why overweight breast cancer survivors are more likely to re-occur has not been well studied, but changes in how insulin works may contribute. Overweight survivors are also at risk for the other chronic diseases associated with obesity. Fortunately, weight losses of as little as 5-7% of baseline body weight can improve risk of chronic disease. An effective behaviorally-based, lifestyle intervention delivered via the internet has been developed at the University of Vermont. This successful intervention has not been tested among breast cancer survivors. Given that women tend to lose muscle mass during cancer therapy the addition of a resistance training component to the weight loss intervention may be important. Therefore the overall goal of this project is to pilot test a proven distantly- delivered behavioral weight loss intervention among overweight breast cancer survivors and to evaluate whether a resistance program results in improvements in lean body mass, while studying how both interventions change insulin sensitivity.

Specifically, this project is a randomized, controlled clinical trial designed to test the effectiveness and acceptability of a 6-month behavioral weight loss intervention with and without resistance training. Participants will be randomized to one of two groups: 1) behavioral weight control treatment via the Internet; or 2) behavioral weight control treatment via the Internet plus a resistance training program. Women eligible to participate include overweight breast cancer survivors who are age 50 or older and 6-36 months past receiving chemotherapy. Assessments will be conducted at baseline and six months and will include measures of body weight, muscle mass, adherence to treatment, and insulin sensitivity.

Обзор исследования

Статус

Завершенный

Условия

Вмешательство/лечение

Тип исследования

Интервенционный

Регистрация (Действительный)

72

Фаза

  • Непригодный

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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 40 лет до 65 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Полы, имеющие право на обучение

Женский

Описание

Inclusion Criteria:

  • Post-menopausal (last period 12 mos prior to study enrollment or oophorectomy)
  • Age 40-65
  • DCIS, Stage I, II, III Breast Cancer
  • BMI between 27-50
  • Completed chemotherapy to treat early stage breast cancer (Stage I-III) no less then 6 months and no more than 48 months from start of study or for specific aim 3 Diagnosis of DCIS or Stage I breast cancer who did not receive chemotherapy.

Exclusion Criteria:

  • Participant can not have a psychotic or central nervous system impairment that would limit compliance with study requirements
  • Evidence of metastatic disease
  • Chemotherapy for cancer other than breast cancer
  • Diabetes mellitus, uncontrolled hypo or hyper thyroidism, liver failure
  • Celiac sprue, inflammatory bowel disease
  • Inability to walk for exercise
  • Lymphedema as indicated by a 2 cm circumference difference at the elbow
  • weight loss in the previous 6 months of 10 lbs or greater

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: Поддерживающая терапия
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Нет (открытая этикетка)

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Экспериментальный: weight loss intervention
Behavioral weight loss intervention
Поведенческий: weight loss intervention
Behavioral weight loss intervention
Экспериментальный: Weight Loss plus Resistance Training
Behavioral weight loss intervention with the addition of resistance training
Поведенческий: Weight Loss
Behavioral weight loss intervention
Активный компаратор: Comparator
Group of women who did not receive chemotherapy
Поведенческий: Weight Loss
Behavioral weight loss intervention

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Identify changes in energy balance and insulin sensitivity parameters in overweight breast cancer survivors after a behavioral weight loss intervention.
Временное ограничение: Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Primary outcome measures include weight, fat free mass, fat mass, total and active energy expenditure, calorie intake and oral glucose tolence test
Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Determine whether the addition of resistance training to a behavioral weight loss intervention preserves muscle mass and improves weight loss or insulin sensitivity in breast cancer survivors.
Временное ограничение: Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Outcomes include weight, fat free mass, fat mass, strength (upper extremity and lower extremity) and oral glucose tolerence test
Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Identify differences in weight loss and energy balance between post menopausal breast cancer survivors who received chemotherapy and those who did not receive chemotherapy as part of their oncologic management.
Временное ограничение: Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Outcomes: weight, fat mass, Fat free mass, total and active energy expenditure, calorie intake
Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Determine differences in insulin sensitivity parameters between post menopausal breast cancer survivors who received chemotherapy and those who did not.
Временное ограничение: Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Oral glusoe tolerence test
Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Determine feasibility, acceptability, and safety of weight loss intervention without resistance training for breast cancer survivors.
Временное ограничение: Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Outcomes include compliance as determined by percent of indiviudals completing each lesson and completing the program. Saftery is assessed by identifying injury or worsening lymphedema. Acceptability is determined with a survey.
Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Assess changes in health-related quality of life after a weight loss intervention.
Временное ограничение: Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Outcomes include SF-36 and FACT-fatigue surveys
Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Determine feasibility, acceptability, and safety of weight loss intervention with resistance training for breast cancer survivors.
Временное ограничение: Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.
Outcomes include compliance as determined by percent of indiviudals completing each lesson and completing the program. Saftery is assessed by identifying injury or worsening lymphedema. Acceptability is determined with a survey.
Time frame is before & after the intervention. The intervention is 6 months. 4 groups of 10-22 women go through together. The groups start at different times. The last group starts May 2011. The last measurements will be obtained early Dec. of 2011.

Соавторы и исследователи

Здесь вы найдете людей и организации, участвующие в этом исследовании.

Спонсор

University of Vermont

Соавторы

University of Vermont Medical Center

Следователи

  • Главный следователь: Kim L Dittus, MD, PhD, University of Vermont/ Fletcher Allen Health Care

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

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 октября 2009 г.

Первичное завершение (Действительный)

1 января 2012 г.

Завершение исследования (Действительный)

1 января 2012 г.

Даты регистрации исследования

Первый отправленный

12 апреля 2010 г.

Впервые представлено, что соответствует критериям контроля качества

28 ноября 2011 г.

Первый опубликованный (Оценивать)

30 ноября 2011 г.

Обновления учебных записей

Последнее опубликованное обновление (Оценивать)

15 января 2013 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

14 января 2013 г.

Последняя проверка

1 января 2013 г.

Дополнительная информация

Термины, связанные с этим исследованием

Ключевые слова

Дополнительные соответствующие термины MeSH

Другие идентификационные номера исследования

  • 10-031

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. .

Подписаться