PATTERN: Predicting the Impact of Treatment Toxicities on Health During Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change in patient-reported neuropathy
研究概览
简要总结
This study investigates the effects of treatment from chemotherapy for cancer on symptoms, function, and falls during treatment and through the recovery phase of cancer care. The goal is to identify simple tests that can help medical providers predict which and when patients show increased risk for falls and functional decline and informing rehabilitation providers about which mobility deficits to target.
详细描述
Aggressive treatments for cancer have improved survival, but often cause serious long-term adverse effects on daily life that last for many years. Chemotherapy-induced peripheral neuropathy (CIPN) is a persistent cancer treatment-related symptom that may negatively impact physical functioning, falls, and quality of life.
The persistence of CIPN symptoms and their relationship with life-threatening falls and disability point to a gap in oncology and follow-up care. A critical first step toward filling this gap is to characterize the natural trajectories of symptoms, functioning, and falls across the in-treatment and recovery phases of cancer care.
This study will prospectively enroll 200 adults with cancer that are scheduled to receive neurotoxic chemotherapy at the Portland campus of Oregon Health & Science University, 5 OHSU Knight Cancer Institute community hematology-oncology clinics, and OHSU research affiliate sites. Data collection occurs at patients' routine clinical appointments and at home via electronic surveys and passive monitoring devices. In the clinic, data collection occurs at 4-6 week intervals during treatment according to each patient's infusion schedule, and then approximately every 3 months for an additional year during routine follow-up care. Clinic-based assessments include tests of perceived sensation (tuning fork, monofilament, and biothesiometer), upper body strength (handgrip dynamometry), lower body strength (chair stand test), static balance (postural sway), and dynamic balance (Timed Up and Go test). Non-clinic-based data collection occurs weekly and assesses symptoms and falls via web-based surveys. At time points corresponding to clinic testing visits, participants are sent home with passive monitoring devices (instrumented socks and wrist-worn activity monitors) that measure physical activity and mobility.
PRIMARY OBJECTIVE:
I. To characterize trajectories of chemotherapy induced peripheral neuropathy (CIPN) symptoms and physical functioning (physical activity, mobility, self-report functioning and disability) and capture the variability in different patient trajectories across treatment and one year of recovery among persons receiving neurotoxic chemotherapy for cancer.
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
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-85 years old on date of enrollment.
- •Diagnosed with stage I-III cancer, or stage IV cancer considered curable, other than cancers or metastases in the brain or spinal cord.
- •Scheduled to receive any neurotoxic chemotherapy including taxane derivative, platinum complex, and/or vinca alkyloids
排除标准
- •Previously received neurotoxic chemotherapy
- •Cognitive difficulties that preclude answering the survey questions, participating in the performance tests, or giving informed consent
- •A medical condition, movement or neurological disorder, or medication use that contraindicates participation in mobility testing and/or that confounds the ability to detect treatment-related changes in balance and mobility. Specific medical conditions include, but are not limited to, severe dystrophy, severe spasticity, epilepsy, seizures, Alzheimer's and dementia, while physical conditions include a severe balance disorder (i.e., later-stage Parkinson's, stroke), inability to ambulate (use of an assistive device permitted), inability to stand for 3 minutes, or severe hearing or vision problem
结局指标
主要结局
Change in patient-reported neuropathy
时间窗: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Measured using the Patient-Reported Outcomes version of the Common Toxicity Criteria and Adverse Events version 1.0 (PRO-CTCAE™) reporting tool. Two items from the PRO-CTCAE™ ask if the patient experienced numbness or tingling in the hands or feet in the last 7 days using a 5-pt scale (0=none to 4=very severe) and how much the symptom interfered with their daily life using a 5-pt scale (0=not at all to 4=very much).
Change in daily functional mobility
时间窗: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Measured using instrumented socks (APDM.com) with inertial sensors embedded into neoprene ankle wraps. Patients wear the instrumented socks during waking hours over 7-day periods that correspond to each in-clinic assessment.
Change in perceived disability
时间窗: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Measured using the disability component of the Late-Life Function and Disability Instrument (LLFDI) which assesses disability in terms of frequency and limitation in performing 16 life tasks. Scores range from 0 to 100, with higher scores indicating less disability.
Change in daily physical activity
时间窗: Baseline up to 1 year after completion of chemotherapy (average of 16 months)
Measured using ActiGraph GT9X Link devices. The ActiGraph algorithms generate accurate and reliable data on total energy expenditure (kcal/d). Patients wear the devices over 7-day periods that correspond to each in-clinic assessment.
次要结局
- Change in objective loss of perceived sensation(Baseline up to 1 year after completion of chemotherapy (average of 16 months))
- Change in quality of life(Baseline up to 1 year after completion of chemotherapy (average of 16 months))
- Change in upper extremity strength(Baseline up to 1 year after completion of chemotherapy (average of 16 months))
- Falls(Baseline up to 1 year after completion of chemotherapy (average of 16 months))
- Change in patient-reported symptoms(Baseline up to 1 year after completion of chemotherapy (average of 16 months))
- Change in static balance(Baseline up to 1 year after completion of chemotherapy (average of 16 months))
- Change in skeletal muscle index(Baseline up to 1 year after completion of chemotherapy (average of 16 months))
- Change in objective functional strength(Baseline up to 1 year after completion of chemotherapy (average of 16 months))
- Change in functional mobility(Baseline up to 1 year after completion of chemotherapy (average of 16 months))
研究者
Kerri Winters
Principal Investigator
OHSU Knight Cancer Institute