Patient Reported Outcomes Following Low-dose Irradiation for Osteoarthritis (PRO-LO): A Single-arm Prospective Registry
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
- Change in Visual Analog Pain Scale (VAPS) Score from Baseline to M3 Post Radiation Treatment Completion
研究概览
简要总结
The goal of this observational registry study is to collect data related to patient reported outcomes (pain, function, quality of life, toxicity) in osteoarthritis (OA) patients receiving standard of care radiation therapy (RT).
详细描述
This is a single-institution, single-arm, prospective, observational study of patients with osteoarthritis who are being treated with standard of care radiation therapy (RT). The purpose of this non-interventional study is to systematically collect data related to patient reported outcomes (pain, function, quality of life, toxicity) with the goal of optimizing approaches to management with radiation therapy and clinical care during follow up. The primary endpoint of this study is a change in visual analog pain scale (VAPS) at 3 months post radiation and a variety of secondary endpoints are aimed at assessing disease control, patient function, avoidance of invasive surgery, and toxicity. Participants will complete patient-reported outcome surveys for pain and joint-specific functional assessment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Willing and able to provide informed consent
- •Established diagnosis of OA of at least 1 joint
- •Inadequately controlled pain due to OA despite attempts with 2 or more other treatment modalities and Visual Analogue Pain Score of 4 or greater.
- •Will undergo radiation as part of their standard of care for OA.
- •At least 55 years old
- •Ability to read and speak English.
排除标准
- •Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine ß-HCG results, obtained within 2 weeks of CT simulation for radiation planning, or on the basis of patient history, e.g.: tubal ligation, hysterectomy or a minimum of 1 year without menses).
- •Estimated life expectancy less than 6 months.
- •Radiation treatment for shoulder OA
- •Patient weight greater than 550lbs
研究组 & 干预措施
Patients with osteoarthritis receiving radiation treatment
Patients with osteoarthritis receiving standard of care radiation treatment at UNC Radiation Oncology clinic. Radiation dose and fractionation prescription is at the physician's discretion.
Typically, this prescription is delivered in 6 fractions, every other day, over 2 weeks.
结局指标
主要结局
Change in Visual Analog Pain Scale (VAPS) Score from Baseline to M3 Post Radiation Treatment Completion
时间窗: Baseline and 3 months post RT
The investigators will use the visual analog 0-10 pain scale (VAPS) and compare the baseline pre-radiation measurement to that measured at 3 months post radiation.
次要结局
- Change in Visual Analog Pain Scale (VAPS) Score Over Time(Baseline up to 5 years post RT)
- Change in Knee Joint-Specific Outcome Over Time(Baseline up to 5 years post RT)
- Change in Hip Joint-Specific Outcome Over Time(Baseline up to 5 years post RT)
- Change in Foot Joint-Specific Outcome Over Time(Baseline up to 5 years post RT)
- Change in Opioid Dosage(Baseline up to 5 years post RT)
- Change in Opioid Frequency(Baseline up to 5 years post RT)
- Invasive Procedures(Up to 5 years post RT)
- Change in NSAID Dosage(Baseline up to 5 years post RT)
- Change in NSAID Frequency(Baseline up to 5 years post RT)
- Change in Arm, Shoulder and Hand Joint-Specific Outcome Over Time(Baseline up to 5 years post RT)