NCT02583815已完成不适用
Feasibility of Activity Monitoring in Patients With Cancer: Physical Activity Monitoring in Cancer Patients (PAMCap)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants Who Use PAM Device
研究概览
简要总结
This is an open label feasibility pilot study of commercially available physical activity monitoring devices in patients receiving systemic therapy at the Harold Simmons Cancer Center, UT Southwestern Medical Center.
详细描述
Study will be conducted for 12 weeks (+/-14 days) of monitoring.
BASELINE ASSESSMENTS Baseline assessment should be performed within 14 days of Week 1.
- Signed informed consent;
- ECOG Performance Status per treating physician (chart abstraction of available data);
- Pathology report confirming cancer diagnosis;
- Psychosocial assessment questionnaires;
- Blood for correlative biomarkers (10 ml);
- Documentation of planned/ongoing chemotherapy regimen
ON-STUDY ASSESSMENTS
- Physical Activity Monitor (PAM)
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •Signed informed consent
- •Age 18 or above
- •Receiving or planning to receive outpatient therapy for any cancer
- •Baseline ECOG status 0-2;
- •Speak and understand English as all Psychological assessment tools included in this study have not been validated in Spanish;
- •Access to smartphone device compatible to sync with PAM Device
排除标准
- •Recent injury which may result in impaired mobility;
- •Major surgery within 4 weeks or till recovery to baseline functioning (per patient) whichever is shorter;
- •Inability to comply with study requirement;
- •Medical, psychiatric condition which in the investigators opinion will affect the successful completion of study;
- •Current use of a wearable PAM device as defined by use of PAM device in the last 6 months
结局指标
主要结局
Number of Participants Who Use PAM Device
时间窗: Week 6 until week 12
The primary endpoint of the study is the feasibility defined by subjects who use a PAM device for more than 42 of 84 days in the observation period (12 weeks +/- 14 days)
次要结局
- Number of Steps(12 Weeks (+/- 14 days))
- Distance Walked(12 Weeks (+/- 14 days))
- Functional Assessment of Cancer Therapy. (FACT-G)(Baseline and every 4 weeks for 12 weeks (+/-14 days))
- Quick Inventory of Depressive Symptomatology (QIDS-SR)(Baseline and every 4 weeks for 12 weeks (+/-14 days))
- Pittsburgh Sleep Quality Index (PSQI)(Baseline and every 4 weeks for 12 weeks (+/-14 days))
- Brief Fatigue Inventory (BFI)(Baseline and every 4 weeks for 12 weeks (+/-14 days))
- Eastern Cooperative Oncology Group Performance Status(Baseline and every 4 weeks for 12 weeks (+/-14 days))
- Time Spent in Activity(12 Weeks (+/- 14 days))
研究者
研究点 (1)
Loading locations...
相似试验
撤回
不适用
Hexoskin Feasibility Study With COVID-19 PatientsCOVID-19NCT04453891Nguyen Thu Ngan Trinh
已完成
不适用
Physical Activity, mHealth and Intellectual Disability - a Pilot StudyIntellectual DisabilityNCT04929106University Hospital of North Norway9
已完成
不适用
Objective Assessment of Physical Activity During Chemotherapy for Breast CancerBreast CancerNCT03045575University of California, San Francisco65
已完成
不适用
Physical Activity Monitoring in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)Chronic Fatigue Syndrome (CFS)Myalgic Encephalomyelitis (ME)NCT04195815Haukeland University Hospital27
已完成
不适用
Walking to better health after strokeStroke - IschaemicStroke - HaemorrhagicPhysical Medicine / Rehabilitation - PhysiotherapyStrokeACTRN12616001733460Dr Lynne Clay23