Group Phone-Based Weight Control for Rural Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Weight loss maintenance
研究概览
简要总结
Women who are obese at breast cancer diagnosis have a 1.5 to 2.5 increased risk of recurrence and death compared to their normal weight counterparts. Moreover, weight gain and decreased physical activity are common after diagnosis and also increase the likelihood of breast cancer recurrence and death. Rural women suffer from health disparities in breast cancer diagnosis and treatment. Women of the most rural counties also have the highest prevalence of obesity compared to urban women. To address these disparities, the overarching objective of this proposal is to develop a clinically effective and cost efficient strategy for delivering a weight control intervention to rural breast cancer survivors. Group phone-based treatment via conference call is a novel treatment delivery approach that the investigators have shown to be effective for initial weight loss among rural breast cancer survivors and more effective than the standard individual phone-based approach among rural women. This innovative method of providing group treatment addresses access barriers in rural areas and may be especially ideal for rural breast cancer survivors because it provides social support in conjunction with a level of anonymity. However, the impact of group phone counseling during extended care for weight loss maintenance beyond 6 months remains unknown. Weight loss maintenance is the more challenging phase of treatment when weight regain is common, and this regain presents a potential risk for breast cancer recurrence. This randomized controlled trial will evaluate the effects of group phone-based treatment for weight loss maintenance among rural breast cancer survivors, compared to an established mail-based education comparison condition, subsequent to a 6 month group phone-based weight loss phase for both conditions. In addition to the intervention impact on weight loss maintenance, the study will provide estimates of incremental cost-effectiveness per kg loss between the two conditions and the impact on secondary outcomes including quality of life, breast cancer risk biomarkers, dietary intake, and physical activity.
详细描述
Phase 1 - Weight Loss (0-6 months)
- Weekly group phone counseling sessions for all participants (12-14 women per group) via conference call for 26 consecutive weeks
- Low-calorie, low-fat diet recommended, including 2 pre-packaged entrees, five one-cup servings of fruits and vegetables and meal replacement shakes (provided free of charge)
- Physical activity program program recommended, beginning with 15 minutes per day, 3 days a week, working toward a goal of 225 minutes a week
- Experienced group counselor facilitates all sessions
Phase 2 - Weight Loss Maintenance (6-18 months)
- Participants randomized to either group phone counseling or mail-based comparison with no phone counseling
- Weight loss maintenance group condition includes 26 bi-weekly phone sessions, while mail-based comparison includes 26 bi-weekly newsletters in the mail
- Focus is on problem-solving
Phase 3 - Transition to Self-Reliance (18-24 months)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 75 Years（Child, Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Breast cancer patients with a BMI 27-45 kg/m2
- •Diagnosis of Stage 0-IIIc disease within the past 10 years (except Stage 0, treated with mastectomy only)
- •Have completed all local and systemic therapy at least 3 months prior to entry
- •Have clearance from their oncologist or current medical provider to participate in a weight control study
- •Must be ≤ 75 years old
- •Post-menopausal
- •Participants must live in a rural area
- •Have access to a phone
- •Able to participate in the physical activity component of the intervention, i.e., be able to walk briskly unassisted and without serious medical risk
- •Weight stable within ten pounds three months prior to entry
排除标准
- •Women with insulin-dependent diabetes
- •Ongoing participation in a formal weight loss program
- •Ongoing use of pharmacotherapy for weight loss
- •Ongoing use of medications that seriously affect weight and metabolism (e.g., steroids, phentermine)
- •Positive screen for current substance abuse, major depression, or binge eating disorder
- •Any cardiac or pulmonary disease preventing participation
- •Treatment for any other cancers within the past year
- •Previous bariatric surgery
结局指标
主要结局
Weight loss maintenance
时间窗: 6 - 18 months
Examine the impact of group phone-based treatment on weight loss maintenance from 6 to 18 months, compared to a mail-based education COMPARISON condition, following a 6-month weight loss phase among obese rural breast cancer survivors.
次要结局
- Breast cancer risk biomarkers(Baseline and 6 and 18 months)
- Quality of life(Baseline and 6, 12, 18, and 24 months)
- Cost effectiveness(18 months)