Nutrition and Exercise During Adjuvant Treatment (NEXT) Study Implementation of a Physician-referred Exercise and Healthy Eating Intervention as Supportive Care in Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 73
- 试验地点
- 3
- 主要终点
- The primary outcome will report as recruitment, retention and adherence rates for the sample and their associated 95% confidence intervals
研究概览
简要总结
This study will offer a supervised exercise program and healthy eating education to women with breast cancer undergoing chemotherapy as a physician-referred program and measure the adoption, adherence and satisfaction with the intervention as well as its health effects. Past trials have demonstrated various health benefits of exercise yet it is not currently part of supportive care and few suitable programs exist in the community or outside of research. This study is expected to address the unique barriers related to exercise in breast cancer survivors and to better understand how the intervention might work in a real life setting.
详细描述
HYPOTHESES (Main):
- The supervised exercise and healthy eating education intervention will be feasible in terms of recruitment (>50%) and retention (>70%) of participants, and; 2) the intervention will be safe and highly acceptable to participants.
JUSTIFICATION: Past trials have demonstrated the benefits of a supervised exercise program in breast cancer survivors during chemotherapy, including reduced side effects of treatment and improvement in physical functioning and quality of life. There are currently no exercise interventions as part of standard cancer care and few suitable programs exist in the community or outside of a research protocol (where they are often associated with strict eligibility criteria and randomization). The proposed study will deliver an exercise and healthy eating program referred by an oncologist as part of supportive cancer care during adjuvant chemotherapy and is expected to specifically address reported barriers to delivery.
OBJECTIVES: The primary aim of this study is to evaluate the feasibility (recruitment rate, adoption and adherence) of a physician referred supervised exercise and healthy eating intervention in newly diagnosed women with breast cancer as supportive care.
The secondary aim is to assess the efficacy for the intervention on:
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •aged 19 years and older;
- •newly diagnosed with early stage (I-IIIA) breast cancer;
- •prescribed adjuvant chemotherapy (with or without radiation) as part of curative treatment for breast cancer; and
- •good comprehension of English
排除标准
- •contraindications for entry into an exercise program (i.e., known cardiovascular disease, uncontrolled diabetes mellitus, or musculoskeletal impairment issue);
- •body mass index (BMI) >40 (morbid obesity);
- •mobility impairment requiring use of mobility aids;
- •stage IV cancer
- •metastatic disease
- •neo-adjuvant chemotherapy (with likelihood of surgery after chemotherapy)
- •Gender exclusion criteria: Male breast cancer is excluded as it is a rare diagnosis.
- •Age exclusion criteria: Based on enrolling adult participants only. Language exclusion criteria: A good comprehension of English is required to receive instruction on the intervention and complete study forms and evaluations.
结局指标
主要结局
The primary outcome will report as recruitment, retention and adherence rates for the sample and their associated 95% confidence intervals
时间窗: 2 years
次要结局
- Means and standard deviations(2 years)
研究者
Kristin Campbell
Kristin Campbell
University of British Columbia