Quality of Life in Amputated Patients Based on Social Deprivation Factors
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Prosthesis Evaluation Questionnaire-Mobility Section (PEQ-MS)
研究概览
简要总结
The purpose of this study is to investigate the quality of life in patients who previously underwent major amputation, and to determine any correlation with social deprivation factors. We hypothesize that patients with increased social deprivation (public or no insurance, lower education, lower income, etc.) will have lower quality of life following amputation.
详细描述
Amputation remains an important treatment option for patients with sarcoma. While limb salvage procedures have become more widely utilized after the advent of chemotherapy, some patients still require amputation in the management of their disease. Studies have shown that patients with social deprivation factors are at higher risk of presenting with advanced disease, and thus are at increased risk of requiring definitive amputation1-3. Additional research shows amputations are more common in lower socioeconomic status patients4. Whether these procedures are done for trauma or infection, they can have morbid outcomes. Prior literature demonstrates that long-term healthcare costs after amputation are higher than in limb salvage5,6. In some patients, the costs associated with prosthetics may be prohibitive and thus impact quality of life. While many factors are thought to ultimately impact life after amputation7, it remains unclear how social deprivation affects outcomes in patients who undergo an amputation.
Data Collection: Under an approved HIPAA waiver, dependent and independent variables will be collected and retrospectively from a chart review. After we receive the initial request, we will perform a chart review to ensure inclusion/exclusion criteria was met. The following information will be obtained through a combination of the report request and subsequent chart review:
- Demographic Information: Name, MRN, Age, Gender, Insurance Status (private v Medicaid v Medicare v uninsured), Address (including Zip Code), Sarcoma Diagnosis, Amputation Level and Date, Medical Comorbidities
- Survey Information: Current work status and Occupation, Race, Education Level (Highest level degree obtained), Use of prosthesis (and why not if answer is No), Prosthesis Information if yes (Manufacturer and Model), SF-36 Questionnaire, MSTS Tumor Score Questionnaire, Prosthesis Evaluation Questionnaire-Mobility Section (PEQ-MS)
In addition to chart review, subjects will also complete a series of questionnaires to assess outcomes related to surgery. The questionnaires include SF-36 Questionnaire, MSTS Tumor Score Questionnaire, and Prosthesis Evaluation Questionnaire-Mobility Section (PEQ-MS). Prior to contact, subjects will receive a letter (waiver of documentation of informed consent) from the attending physicians describing the study and asking them if they would like to participate in the study by completing the questionnaires and allowing the use of their data for the study. The letter from the attending physicians will also explain that subjects will receive an email or telephone call from a research team member. Subjects will have the opportunity to complete the questionnaire via phone, regular mail, or email using the survey function in RedCap.
Subjects that are willing to complete the questionnaire will be enrolled under a waiver of documentation of informed consent. Subjects that are not willing to complete the questionnaire but will allow their data to be used will be enrolled under a waiver of documentation of informed consent (i.e.: Subject states on the phone they don't want to complete questionnaire, but they give permission for us to retrospectively use their data). Those subjects that have inadequate data or cannot be reached after a reasonable effort will be enrolled under a full waiver of informed consent to use their retrospective data. If subjects indicate on the phone or via email, they do not want their retrospective data used we will withdraw the subject and delete all retrospective data.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 99 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients who underwent major amputation via orthopaedic oncology attending at UF (transtibial, transfemoral, hip disarticulation, transhumeral, or trans-forearm)
- •Must be at least 6 months post amputation at the time of survey administration
- •Patients undergoing amputation for sarcoma, trauma, or chronic infection
排除标准
- •Pediatric patients (<18 years of age)
- •Adult patients with the following amputations: ray resection, transmetacarpal, wrist disarticulation, any other amputation distal to the carpi, Syme (ankle disarticulation), Chopart amputation, transmetatarsal, any other amputation distal to the tibia
- •Patients undergoing amputations for diabetes or vascular disease
- •Patients within 6 months post-operatively from their amputation
结局指标
主要结局
Prosthesis Evaluation Questionnaire-Mobility Section (PEQ-MS)
时间窗: One visit at least 6 months removed from the amputation
A questionnaire that evaluates the perceived potential for mobility using prosthetic devices over the past 4 weeks
MSTS Tumor Score Questionnaire
时间窗: One visit at least 6 months removed from the amputation
A physician/patient-completed questionnaire designed to assess functional outcome for patients with sarcomas in the extremities.
SF-36 Questionnaire
时间窗: One visit at least 6 months removed from the amputation
A survey set of generic, coherent, and easily administered quality-of-life measures.
次要结局
未报告次要终点
