Taking Health Realization Into Valued Eating and Exercise (THRIVE): A Feasibility Study of an Intervention to Prevent Weight Gain for Breast Cancer Survivors During Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Feasibility of conducting the weight gain prevention intervention, measured as the percent of screened participants that are eligible and agree to participate
研究概览
简要总结
This pilot clinical trial studies a health education intervention in reducing weight gain in patients with newly diagnosed stage I-IV breast cancer undergoing chemotherapy. A health education program may reduce weight gain and improve quality of life in patients undergoing chemotherapy for breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of conducting a weight maintenance intervention, in terms of recruiting and retaining participants.
II. To obtain preliminary data on the effectiveness of an intervention to prevent weight gain on body composition, self-efficacy, perceived stress, fatigue, depression, exercise capacity, and health-related quality of life (HRQL). Changes in physical activity and dietary intake will also be monitored.
III. To determine if the weight control protocol requires refinement for use in a randomized controlled trial.
IV. To determine how many participants opt to enroll in a short-term healthy lifestyle program at completion of the final testing visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with newly-diagnosed breast cancer, stage I-IV who are within first two rounds of chemotherapy
- •3.1.2 Women who are receiving, or scheduled to receive, one of the following classes of therapy in the adjuvant or neo-adjuvant setting: anthracyclines, taxanes, cyclophosphamide, or trastuzumab. Participants must be within their first two rounds of chemotherapy - Body mass index (BMI) > 20
- •Treating physician approval to participate in study
- •Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
排除标准
- •Diagnosis of recurrent breast cancer
- •Women who are already participating in a formal or medically prescribed weight management program
- •Women who have already completed more than two rounds of chemotherapy
- •Women who are pregnant or nursing
研究组 & 干预措施
Supportive care (health education program)
See Detailed Description.
干预措施: educational intervention (Other)
Supportive care (health education program)
See Detailed Description.
干预措施: counseling intervention (Other)
Supportive care (health education program)
See Detailed Description.
干预措施: telephone-based intervention (Behavioral)
Supportive care (health education program)
See Detailed Description.
干预措施: questionnaire administration (Other)
Supportive care (health education program)
See Detailed Description.
干预措施: quality-of-life assessment (Procedure)
结局指标
主要结局
Feasibility of conducting the weight gain prevention intervention, measured as the percent of screened participants that are eligible and agree to participate
时间窗: Baseline
Reasons why participants are not eligible will be reported and inclusion/exclusion criteria will be reevaluated. The proportion of participants who completed all sessions and testing visits will be estimated and compared. Barriers to recruitment (e.g., timing of intervention, inconvenience, time constraints, participant feeling too sick) will be recorded to assist in designing the larger trial.
次要结局
- Effect of the intervention on fatigue(Up to 52 weeks)
- Effect of the intervention on physical activity participation(Up to 52 weeks)
- Effect of the intervention on perceived stress(Up to 52 weeks)
- Effect of the intervention on body composition(Up to 52 weeks)
- Effect of the intervention on fruit, vegetable, and fat intake(Up to 52 weeks)
- Effect of the intervention on self-efficacy(Up to 52 weeks)
- Effect of the intervention on 6 minute walk distance(Up to 52 weeks)
- Sample size for future larger trials(Up to 52 weeks)
- Effect of the intervention on health-related quality of life(Up to 52 weeks)