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临床试验/NCT04575402
NCT04575402进行中(未招募)不适用

Evaluating the Role of Wearable Technology and Patient-reported Outcomes to Monitor Physical Function Decline in Prostate Cancer Survivors

Cedars-Sinai Medical Center1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年2月19日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
40
试验地点
1
主要终点
Physical function decline within 3 months from baseline

研究概览

简要总结

Prospective observational research study to evaluate the role of wearable activity monitors to predict physical function decline among prostate cancer survivors receiving ADT.

详细描述

Physical function is a known predictor of QOL in advanced prostate cancer patients and key measure of treatment tolerability. While treatment with Androgen Deprivation Therapy (ADT) improves survival, it is associated with significant toxicities that lead to physical function (PF) decline. The average age of incident prostate cancer is 66 years, and in this older group of men, chronic comorbid conditions often co-occur with diagnosis, further adding to the risk for PF decline. With over 2.9 million prostate cancer survivors in the US, there is an increasing demand for adequate symptom monitoring and PF assessment throughout cancer care. However, there are currently no validated methods to systematically evaluate and predict PF decline. Thus, the overarching objective of this proposal is to determine whether the use of wearable technology to monitor objective daily activity combined with routine symptom reporting can predict PF decline. To accomplish this, we propose a mixed-methods approach that will provide quantitative information to help identify PC survivors at higher risk for PF decline as well as a qualitative aim gain a deeper understanding of the perceived relationships that PC survivors have with their physical activity levels and treatment symptoms.

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
Male
接受健康志愿者

入选标准

  • Prostate cancer patients receiving ADT (+/- radiation) or planning to receive ADT. Start date of ADT must be planned for no more 7 days after baseline, or patients must have started ADT within 6 months prior to enrollment.
  • 18 years or older
  • Ambulatory (use of walking aids, such as cane and rollator, is acceptable)
  • Access to a device that has the capability to sync to the Fitbit
  • Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
  • English or Spanish speaking
  • Informed consent obtained from subject and ability for subject to comply with the requirements of the study.

排除标准

  • Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment. However, removable hearing aids are permitted.

结局指标

主要结局

Physical function decline within 3 months from baseline

时间窗: 3 months

Patient-reported physical function defined as 5-point change in standardized NIH PROMIS t-scores (mean 50, SD: 10), where higher scores represent higher physical function)

Absolute change in average step counts at 3 months from baseline

时间窗: 3 months

Change will be calculated based on difference in average weekly step count at baseline from the average weekly step count at end-of-study visit as measured using a Fitbit activity monitor where mean weekly Fitbit activity values will be calculated

次要结局

  • Mean change in Fitbit 24-hour activity(3 months)
  • Key themes and concepts surrounding the relationships patients have with their treatment symptoms and how they affect their daily activity, as assessed in qualitative interviews.(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gillian Gresham

Assistant Professor

Cedars-Sinai Medical Center

研究点 (1)

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