Weight Reduction Intervention for Breast Cancer Survivors
Ключови думи
Резюме
Описание
Background: Overweight or obesity is an established negative prognostic factor in both premenopausal and postmenopausal breast cancer. Adverse effects of adiposity on prognosis may be explained by effects on gonadal hormones, insulin, insulin-like growth factor (IGF)-I, IGF binding proteins (IGFBPs), and leptin.
Objective/Hypothesis: This study tests whether a multifaceted approach can achieve weight loss and maintenance in overweight or obese breast cancer survivors. The intervention incorporates cognitive-behavioral therapy, increased physical activity, diet modification, and strategies to improve body image and self-acceptance. This approach and intervention were developed and pilot-tested with support from a previous peer-reviewed grant. Weight change from baseline to one year in the pilot study (n=85) was -5.2 (6.3) kg (mean [SD]) in the intervention group vs. -0.1 (6.5) kg in the control group (P < 0.05), using intent to treat analysis with baseline values carried forward for dropouts.
Specific aims: (1) To test whether the intervention promotes weight loss and maintenance of that loss over an 18-month time period in a larger group; (2) To describe the effect of the intervention on hormonal factors (insulin, leptin, IGF-I, IGFBP-1, IGFBP-3, sex-hormone binding globulin, and serum estrogens); and (3) To describe the relationships between body weight and weight reduction and measures of psychosocial factors (health-related quality of life, fatigue, depression, eating attitudes, and weight and shape concerns).
Study design: The study targets 253 overweight or obese women previously treated for early stage breast cancer and utilizes a randomized study design with subjects assigned to the group-based healthy weight management program (with individualized telephone counseling support) or a wait-list control group. Data collection includes anthropometric and psychosocial measures, body composition (dual-energy x-ray absorptiometry), cardiopulmonary fitness testing, and hormonal measures at baseline and six and 18 months.
Дати
| Последна проверка: | 08/31/2011 |
| Първо изпратено: | 10/15/2008 |
| Очаквано записване подадено: | 10/15/2008 |
| Първо публикувано: | 10/16/2008 |
| Изпратена последна актуализация: | 09/15/2011 |
| Последна актуализация публикувана: | 09/19/2011 |
| Действителна начална дата на проучването: | 12/31/2004 |
| Приблизителна дата на първично завършване: | 01/31/2009 |
| Очаквана дата на завършване на проучването: | 11/30/2009 |
Състояние или заболяване
Интервенция / лечение
Behavioral: 1
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: 1 The intervention program consists of group sessions provided according to the following schedule: weekly for 4 months, every other week for two months, and follow-up monthly sessions through 18 months of active subject participation. The time points for data collection from all subjects are baseline, 6 months, and 18 months. The group sessions offered to the treatment study arm are closed-group contingents with an average of 12-15 women assigned to each group. | Behavioral: 1 The intervention program emphasizes regular physical activity, healthy eating, and psychological components within the structure of CBT for obesity. The physical activity component emphasizes planned aerobic exercise, increased physical activity and strength training. A deficit of 500-1000 kcal/day is the recommended level of dietary modification to promote weight loss and maintenance. Group sessions are held weekly for 4 months, every other week for two months, and monthly sessions through 18 months. Data are collected at baseline, 6 months, and 18 months. Wait-list group subjects will receive general contact without specific reference to weight management topics through a 24-month period of data collection and will then be provided intervention materials in a seminar format. |
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: - Diagnosed with Stage I-IIIA breast cancer within the previous 10 years - Have completed initial treatments (i.e., surgery, adjuvant chemotherapy, radiation therapy) - Have initial BMI >25.0 kg/m2 - A minimum of 15 kg over ideal weight - Willingness and ability to attend group meetings and to maintain contact with the investigators for 18 months - Ability to provide dietary and exercise data by telephone at prescribed intervals. Exclusion Criteria: - Inability to participate in physical activity because of severe disability |
Резултат
Първични изходни мерки
1. Weight loss [2 years]
Вторични изходни мерки
1. Increase in physical activity levels [2 years]
