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临床试验/NCT03045575
NCT03045575已完成不适用

Objective Assessment of Physical Activity During Chemotherapy for Breast Cancer

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2016年8月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
1
主要终点
Adherence

研究概览

简要总结

This is a prospective observational study designed to determine the feasibility and acceptability of objectively measuring physical activity, sedentary time, and sleep using the Fitbit Charge HR wristband. 50 patients who have been diagnosed with breast cancer and are planning to initiate chemotherapy will be invited to participate in this study, and we will measure general and breast-specific quality-of-life using Patient-Reported Outcomes Measurement Information System (PROMIS) measures for 3-6 months after completion of chemotherapy.

详细描述

Over 3.1 million women are currently living with a diagnosis of breast cancer in the United States (US), representing 41% of all female cancer survivors in the US. The increased breast cancer survival rate has necessitated a shift in cancer care toward developing interventions to empower patients to improve their quality-of-life, and perhaps prognosis, during and after treatment. Among women diagnosed with early-stage (I or II) breast cancer, around 40% will receive chemotherapy. Among women diagnosed with late-stage (III or IV), around 75% will receive chemotherapy. Adjuvant chemotherapy is associated with many side effects, including fatigue, nausea, disturbed sleep, decreased activity, and weight gain. Women receiving chemotherapy gain an average of 2.5 to 6.2 kg during therapy. Weight gain increases the risk of breast cancer recurrence and mortality, as well as cardiovascular disease, diabetes, and second primary cancers. Physical activity alleviates or reduces both short and long term treatment side effects of chemotherapy, including weight gain, and restores physical functioning in breast cancer patients. Additionally, randomized controlled trials in breast cancer patients have shown that adding exercise to chemotherapy programs can improve breast cancer outcomes.

Although there are many benefits of engaging in physical activity during cancer treatments, activity levels typically decline throughout treatment. Existing research has relied on self-reported activity levels, which is a poor measure of low-intensity activities and can only capture a periodic snap shot of activity levels. This study will provide objective physical activity data across the entirety of the patient's chemotherapy treatments. This in depth data will provide a new perspective on the patterns of activity levels and help to identify if there are critical times in which to intervene to prevent physical activity declines.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • have been diagnosed with breast cancer
  • be planning to initiate chemotherapy for breast cancer at University of California, San Francisco (UCSF)
  • be able to speak and read English, or have a family member or friend who can assist in translating and completing surveys in English
  • be able to walk unassisted
  • be able to navigate websites, fill out forms on the web, communicate by email, and have regular access to the internet

排除标准

  • We will exclude individuals who cannot speak or read English unless they have a friend or family member who can assist in translating and completing quality of life surveys in English. In addition, the Fitbit® requires the ability to connect to the Internet and input data in a website, therefore we will exclude patients with no regular access to the Internet or who are unable to fill out forms on the web or navigate websites. We will exclude patients who are unable to walk unassisted.

结局指标

主要结局

Adherence

时间窗: 9 months

Adherence, defined at the percentage of weeks that a participant successfully syncs their Fitbit at least once a week during the course of the study, will be reported as a point estimate and 95% confidence interval

次要结局

  • Quality of Life - Physical Function(Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.)
  • Quality of Life - Anxiety(Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.)
  • Quality of Life - Fatigue(Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.)
  • Quality of Life - Social roles(Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.)
  • Quality of Life - Depression(Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.)
  • Quality of Life - Applied cognition general concerns(Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.)
  • Quality of Life - Applied cognitive abilities(12 months from start of chemotherapy)
  • Quality of Life - Sleep disturbance(Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.)
  • Body Size(Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.)
  • Quality of Life - Sleep-related impairment(Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.)
  • Quality of Life - Exercise Vital Sign(Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.)
  • Quality of Life - Pain interference(Baseline, midpoint of chemotherapy, end of chemotherapy, and 6 months following end of chemotherapy.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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