Life on the Go 2: Evaluating the Effect of Physical Activity of Patients With Recurrent Ovarian Cancer Using State of the Art Activity Tracking Device
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number of participants who wear and track g data using the Fitbit Charge 2 activity wrist band
研究概览
简要总结
This phase II trial studies how well physical activity monitored by Fitbit Charge 2 works in improving quality of life in participants with ovarian, primary peritoneal, or fallopian tube cancer that has come back. A modern, state of the art activity tracking device (Fitbit Charge 2) may help to measure physical activity, heart rate, and sleep pattern, and may help doctors to learn whether physical activity level has any relationship to energy level, sleep duration and quality, toxicity from chemotherapy, immune cells in blood, and bacterial composition in gut.
详细描述
PRIMARY OBJECTIVES:
I. To demonstrate feasibility of wearing (at least 70% of the time) and tracking data (daily physical activity, heart rate, sleep pattern) using a Fitbit Charge 2 activity wrist band (or any comparable activity wristband that the patient may already use and is capable of the same functions, such as Fitbit Charge HR, Fitbit Surge or Fitbit Blaze) in 30 patients with recurrent ovarian cancer who are progressing on treatment and starting first cycle of a new regimen for a total of 9 months.
II. To demonstrate feasibility of using persuasive fitness technologies to increase physical activity by 30 % from baseline and to increase patients? active minutes to 30 minutes, five times a week, or by 30% if patient is meeting that goal already, for 6 months period of time.
SECONDARY OBJECTIVES:
I. To assess how patient?s physical activity level, without providing specific counseling or exercise regimen, compares to American Heart Association (AHA)?s recommendation and to the target of 10,000 steps promoted by various activity tracking devices.
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
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1
- •Have recurrent epithelial ovarian, primary peritoneal or fallopian tube cancer (serous, clear cell, endometrioid or mucinous)
- •Patient is willing to wear activity tracking device at least 70% of the time for the duration of the study (9 months)
- •Patient is getting cancer treatment and surveillance visit at Roswell Park Cancer Institute during the study period
- •Patient is willing to participate in quality of life (QOL) questionnaires and blood and stool collection throughout the study for translational research purposes
- •Has no risk factors for increased risk for exercise related complications assessed by 2017 Physical Activity Readiness Questionnaire for Everyone (PAR-Q+) questionnaire and principal investigator (PI)/cooperative (Co)-PI
- •If positive screening test on 2017 PAR-Q+ questionnaire, medical clearance need to be documented by PI/Co-PI with doctor of medicine (MD) degree and/or primary care physician or cardiologist, if deemed necessary by the PI/Co-PIs prior to starting increased physical activity (PA) portion of the trial
排除标准
- •Patient with serious psychiatric illness (e.g. lifetime bipolar disorder, schizophrenia or other psychosis, serious personality disorder, severe major depressive disorder or recent suicide or psychiatric hospitalization in the previous 12 months)
- •Patients with a life expectancy of less than 6 months
- •Patients may not have any other active malignancy that currently requires treatment with the exception of non-melanoma skin cancer
- •Unwilling or unable to follow protocol requirements
结局指标
主要结局
Number of participants who wear and track g data using the Fitbit Charge 2 activity wrist band
时间窗: Up to 3 years
If observed compliance rate is 70% , use of the device will be deemed feasible.
Persuasive effect of using the Fitbit Charge 2 on physical activity (PA)
时间窗: Up to 3 years
Will be assessed by comparing average daily PA measurements (described above) between pre- and post-counseling, using two-sided t-tests.
次要结局
- Daily steps(Up to 3 years)
- Heart Rate(Up to 3 years)
- Change in Quality of Life Questionnaire scores(Up to 3 years)