Pilot Study of a Consumer-Based Activity Monitor (Fitbit Zip) in Evaluating Perioperative Activity of Older Adults Undergoing Major Oncologic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of Patients Who Self-report Wearing the Consumer-based Activity Monitor at Least 16 Days of the 21 Day Period
研究概览
简要总结
This pilot clinical trial studies how well consumer-based activity monitor works in evaluating and measuring activity of older patients with abdominal cancer undergoing surgery. Consumer-based activity monitor (CAM) may identify patients who are at-risk for increased post-surgery medical problems. With early identification of at-risk patients, CAM provide supervised exercise in the preoperative and postoperative periods to improve over mobility and potentially decrease preoperative complications among patients undergoing major abdominal surgery.
详细描述
PRIMARY OBJECTIVES:
I. To demonstrate the feasibility and adherence of using a consumer-based activity monitor during the preoperative period both in the hospital as well as at home.
SECONDARY OBJECTIVES:
I. To evaluate the ability of a consumer-based activity monitor to demonstrate a 50% decrease in average daily steps for participants before and after major oncologic surgery.
II. To characterize in-home movement among older cancer patients. III. To compare in-home CAM data to in-clinic pre- and post-operative mobility testing using the Short Physical Performance Battery (SPPB).
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
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eastern Cooperative Oncology Group (ECOG) < 3
- •Histologically or cytologically confirmed gastrointestinal or peritoneal malignancy
- •Scheduled for major open abdominal oncologic surgery
- •Able to walk without an assistive device
- •Able to complete a minimum of 4 days of in-home activity monitoring before operation
- •Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document
- •Ability to understand and complete the study survey instruments in English
排除标准
- •Cerebrovascular accident (CVA) or stroke within the past 6 months
- •Severe or symptomatic heart disease
- •Currently residing in nursing or assisted living facility
- •Neurologic disorder that impairs ambulation (e.g. Parkinson's)
- •Actively undergoing treatment for a psychiatric illness
- •Resting blood pressure > 160/100
- •Clinically evident cognitive and/or behavioral impairment that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures, specifically completing home activity monitoring
- •Current alcohol or other substance abuse or history of abuse within 6 months prior to screening
- •Post-operative complications that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures, specifically completing home activity monitoring
- •Unable to understand and complete the study survey instruments in English
研究组 & 干预措施
Supportive care (consumer-based activity monitor)
Patients wear Fitbit Zip (portable pedometer device) to track physical activity for 7 days before undergoing surgery and for 21 more days after undergoing surgery.
干预措施: Management of Therapy Complications Fitbit Zip (portable pedometer device) (Device)
Supportive care (consumer-based activity monitor)
Patients wear Fitbit Zip (portable pedometer device) to track physical activity for 7 days before undergoing surgery and for 21 more days after undergoing surgery.
干预措施: Questionnaire Administration (Other)
Supportive care (consumer-based activity monitor)
Patients wear Fitbit Zip (portable pedometer device) to track physical activity for 7 days before undergoing surgery and for 21 more days after undergoing surgery.
干预措施: Quality-of-Life Assessment (Other)
结局指标
主要结局
Number of Patients Who Self-report Wearing the Consumer-based Activity Monitor at Least 16 Days of the 21 Day Period
时间窗: 21 days
Feasibility will be defined as the number of patients who self-report wearing the CAM device at least 16 days of the 21 day period.
次要结局
- Change in Daily Steps for Participants Before and After Major Oncologic Surgery(baseline and 90 days)
- Change in Short Physical Performance Battery (SPPB)(baseline and 90 days)
- Change in Health-related Quality of Life (FACT-G) Questionnaire(baseline and 90 days)
- Change in Pepper Assessment Tool for Disability (PAT-D)(baseline and 90 days)
- Change in the Mobility Assessment Tool-Short Form (MAT-sf).(baseline and 90 days)
- Change in Fatigue Assessment- Fatigue Visual Analog Scale (FVAS).(baseline and 90 days)
- Change in Duration of 400-meter Walk(baseline and 90 days)
- Change in CHAMPS Between the Pre- and Post-operative Period(baseline and 90 days)
- Change in Pain Assessment -Pain Visual Analog Scale, (PVAS)(baseline and 90 days)