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).
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.
Study Type
OBSERVATIONAL
Enrollment
40
UNC Chapel Hill
Chapel Hill, North Carolina, United States
Change in Visual Analog Pain Scale (VAPS) Score from Baseline to M3 Post Radiation Treatment Completion
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.
Time frame: Baseline and 3 months post RT
Change in Visual Analog Pain Scale (VAPS) Score Over Time
The investigators will use the visual analog 0-10 pain scale (VAPS), where 0 is no pain and 10 is the worst physical pain imaginable, and compare the baseline pre-radiation measurement to that assessed at 6 weeks, 6 and 12 months, and yearly up to 5 years post radiation (RT). Higher scores indicate a worse outcome.
Time frame: Baseline up to 5 years post RT
Change in Hip Joint-Specific Outcome Over Time
Joint-specific outcomes measures scales will include the Hip Injury and Osteoarthritis Outcome Score (HOOS). With 1 being the most functional usage of the joint, and 5 being least functional usage of the joint. The higher the value, the less functional outcome of the joint. Investigators will compare the baseline pre-radiation measurement to that assessed at 6 weeks, 3, 6 and 12 months, and yearly up to 5 years post radiation.
Time frame: Baseline up to 5 years post RT
Change in Knee Joint-Specific Outcome Over Time
Joint-specific outcomes measures scales will include the Knee Injury and Osteoarthritis Outcome Score (KOOS). With 1 being the most functional usage of the joint, and 5 being least functional usage of the joint. The higher the value, the less functional outcome of the joint. It will compare the baseline pre-radiation measurement to that assessed at 6 weeks, 3, 6 and 12 months, and yearly up to 5 years post radiation.
Time frame: Baseline up to 5 years post RT
Change in Arm, Shoulder and Hand Joint-Specific Outcome Over Time
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Joint-specific outcomes measures scales will include the Disability of Arm Shoulder and Hand (DASH). With 1 being the most functional usage of the joint, and 5 being least functional usage of the joint. The higher the value, the less functional outcome of the joint. It will compare the baseline pre-radiation measurement to that assessed at 6 weeks, 3, 6 and 12 months, and yearly up to 5 years post radiation.
Time frame: Baseline up to 5 years post RT
Change in Foot Joint-Specific Outcome Over Time
Joint-specific outcomes measures scales will include the Foot \& Ankle Disability Index Score (FADI). With 1 being the most functional usage of the joint, and 5 being least functional usage of the joint. The higher the value, the less functional outcome of the joint. It will compare the baseline pre-radiation measurement to that assessed at 6 weeks, 3, 6 and 12 months, and yearly up to 5 years post radiation.
Time frame: Baseline up to 5 years post RT
Change in NSAID Dosage
The investigator will compare NSAID doses at baseline to that measured at 6 weeks, 3, 6, and 12 months, and yearly up to 5 years post-radiation.
Time frame: Baseline up to 5 years post RT
Change in Opioid Dosage
The investigator will compare opioid doses at baseline to that measured at 6 weeks, 3, 6, and 12 months, and yearly up to 5 years post-radiation.
Time frame: Baseline up to 5 years post RT
Change in NSAID Frequency
The investigator will compare NSAID frequencies at baseline to that measured at 6 weeks, 3, 6, and 12 months, and yearly up to 5 years post radiation.
Time frame: Baseline up to 5 years post RT
Change in Opioid Frequency
The investigator will compare opioid frequencies at baseline to that measured at 6 weeks, 3, 6, and 12 months, and yearly up to 5 years post radiation.
Time frame: Baseline up to 5 years post RT
Invasive Procedures
The investigator will report invasive procedures to treat the radiated joint experienced by each subject for the treatment of OA.
Time frame: Up to 5 years post RT