Women's Activity and Lifestyle Study in Connecticut
Ключови думи
Резюме
Описание
Currently, the American Cancer Society recommends a physically active lifestyle for cancer survivors to increase disease-free survival from cancer and other chronic diseases, and to improve quality of life. Studies of a strong benefit of physical activity on improving QOL following other types of cancer treatment, e.g., breast cancer, are well documented in the literature; yet very few studies of physical activity and QOL after a diagnosis of ovarian cancer have been published. Therefore, clinical trials of exercise on common physical and psychological consequences of ovarian cancer and its treatments are warranted.
The primary aims of our study are to examine, in 230 women who have completed treatment for Stage I-IV ovarian cancer, the impact of a moderate-intensity aerobic exercise intervention vs. attention control on:
- Quality of Life
- Body Composition (weight, BMI, total and % body fat, waist and hip circumference)
- Hormones possibly associated with physical activity and ovarian cancer prognosis (insulin, IGF-I, IGF-II, IGF binding protein-3, CRP, leptin, estrone, estradiol, free estradiol, and sex-hormone binding globulin, osteopontin, MIF, prolactin, and CA-125)
- Cardiorespiratory Fitness - an objective measure of functional capacity and adherence to exercise.
Hypotheses: Women randomized to exercise will experience improvements in quality of life, body composition, hormone levels, and cardiorespiratory fitness compared to women randomized to usual care.
Our trial could suggest a unique and important role for exercise in ovarian cancer care given that physical and functional aspects of QOL are often the most compromised in ovarian cancer patients.
Дати
| Последна проверка: | 03/31/2014 |
| Първо изпратено: | 05/16/2012 |
| Очаквано записване подадено: | 04/02/2014 |
| Първо публикувано: | 04/07/2014 |
| Изпратена последна актуализация: | 04/17/2018 |
| Последна актуализация публикувана: | 04/19/2018 |
| Действителна начална дата на проучването: | 04/30/2009 |
| Приблизителна дата на първично завършване: | 05/31/2013 |
| Очаквана дата на завършване на проучването: | 05/31/2013 |
Състояние или заболяване
Интервенция / лечение
Behavioral: Exercise
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Active Comparator: attention control Women randomized to attention control will receive the same attention as women randomized to exercise intervention, i.e., weekly phone calls for 6 months. Each call is about 15 min. Women in the attention control will receive information on ovarian cancer health education topics. | |
| Experimental: exercise Women randomized to exercise will receive telephone-counseling weekly for 6 months to increase their exercise |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | Female |
| Приема здрави доброволци | Да |
| Критерии | Inclusion Criteria: - stage I-IV ovarian cancer - less than 76 yrs of age Exclusion Criteria: - exercising |
Резултат
Първични изходни мерки
1. Change from Baseline in Functional Assessment of Cancer Therapy-Ovarian (FACT-O) [6 months]
2. Change from Baseline in Functional Assessment of Cancer Therapy-Fatigue (FACT-F) [6 months]
3. Change from Baseline in Short Form 36 (SF-36) [6 months]
