Pre-Operative ERAS® (Enhanced Recovery After Surgery): Randomized Feasibility Trial of Implementing Individualized Prehabilitation for People Undergoing Neo-Adjuvant Radiotherapy and Lower Limb Soft-Tissue Sarcoma Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Efficacy potential
研究概览
简要总结
This clinical trial evaluates whether patients with deep soft tissue sarcomas who receive a tailored prehabilitation exercise regimen during standard radiotherapy and prior to standard of care surgery have better recovery and surgical outcomes than those who do not. Patients undergoing surgery to soft tissue sarcomas are at high risk for post-operative disability, which is associated with high rates of depression and poor health-related quality of life. Prehabilitation is the practice of exercising before surgery to ensure that the patient is in the best possible condition. It allows patients to prepare their bodies for recovery after surgery, which may result in better surgical outcomes, recovery, and quality of life after surgery.
详细描述
PRIMARY OBJECTIVES:
I. To determine if a tailored prehabilitation program focusing on functional optimization of spared limb tissue in two groups of patients with localized, lower extremity soft tissue sarcoma, one with prehabilitation and one with equal attention and informational support, improves functional outcome as measure by the Toronto Extremity Salvage Score (TESS).
II. To identify the measures and metrics most responsive to the intervention using the (TESS), Six Minute Walk Test (6MWT), wearable Heel2Toe sensor technology, and daily step count.
III. To estimate recruitment, retention, adherence, and acceptability rates.
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Care Provider)
盲法说明
Masking of treatment assignment to the surgeon and radiation oncologist.
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
- •Histologically or cytologically-proven deep soft tissue sarcoma (STS) of the lower extremity
- •Localized
- •Adults, 18 and older
- •All gender types
- •Subjects must be able to provide appropriate consent or have an appropriate representative available to do so
排除标准
- •Soft tissue sarcomas that are in a superficial location relative to fascia
- •Patients with metastatic disease (distant or nodal)
- •Both and upper and lower extremity involvement
研究组 & 干预措施
Arm I (prehabilitation physical therapy)
Patients perform personalized prehabilitation physical therapy exercises BID 5 days per week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery, attend telemedicine visits with a physical therapist once a week for 9 weeks, and receive educational materials. Patients undergo MRI and CT at week 9.
干预措施: Educational Intervention (Other)
Arm I (prehabilitation physical therapy)
Patients perform personalized prehabilitation physical therapy exercises BID 5 days per week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery, attend telemedicine visits with a physical therapist once a week for 9 weeks, and receive educational materials. Patients undergo MRI and CT at week 9.
干预措施: Computed Tomography (Procedure)
Arm I (prehabilitation physical therapy)
Patients perform personalized prehabilitation physical therapy exercises BID 5 days per week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery, attend telemedicine visits with a physical therapist once a week for 9 weeks, and receive educational materials. Patients undergo MRI and CT at week 9.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm I (prehabilitation physical therapy)
Patients perform personalized prehabilitation physical therapy exercises BID 5 days per week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery, attend telemedicine visits with a physical therapist once a week for 9 weeks, and receive educational materials. Patients undergo MRI and CT at week 9.
干预措施: Physical Therapy (Procedure)
Arm I (prehabilitation physical therapy)
Patients perform personalized prehabilitation physical therapy exercises BID 5 days per week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery, attend telemedicine visits with a physical therapist once a week for 9 weeks, and receive educational materials. Patients undergo MRI and CT at week 9.
干预措施: Questionnaire Administration (Other)
Arm I (prehabilitation physical therapy)
Patients perform personalized prehabilitation physical therapy exercises BID 5 days per week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery, attend telemedicine visits with a physical therapist once a week for 9 weeks, and receive educational materials. Patients undergo MRI and CT at week 9.
干预措施: Telemedicine (Other)
Arm II (educational materials)
Patients receive educational materials and attend a telemedicine visit with a research assistant once a week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery. Patients undergo MRI and CT at week 9.
干预措施: Magnetic Resonance Imaging (Procedure)
Arm II (educational materials)
Patients receive educational materials and attend a telemedicine visit with a research assistant once a week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery. Patients undergo MRI and CT at week 9.
干预措施: Computed Tomography (Procedure)
Arm II (educational materials)
Patients receive educational materials and attend a telemedicine visit with a research assistant once a week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery. Patients undergo MRI and CT at week 9.
干预措施: Educational Intervention (Other)
Arm II (educational materials)
Patients receive educational materials and attend a telemedicine visit with a research assistant once a week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery. Patients undergo MRI and CT at week 9.
干预措施: Questionnaire Administration (Other)
Arm II (educational materials)
Patients receive educational materials and attend a telemedicine visit with a research assistant once a week for 8 weeks while receiving standard of care radiotherapy and prior to standard of care surgery. Patients undergo MRI and CT at week 9.
干预措施: Telemedicine (Other)
结局指标
主要结局
Efficacy potential
时间窗: Up to 22 weeks
Univariate descriptive statistics and frequency distributions will be calculated, as appropriate for all variables. Baseline values for demographic, clinical, and outcome variables will be tabulated for the treatment groups. Between-group effect sizes will be estimated for continuous outcomes.
Gait quality
时间窗: Up to 22 weeks
Gait quality will be measured during the 6MWT using a wearable developed by the team, Heel2Toe sensor. The parameters of gait quality will include proportion of steps with as strong a heel strike pre-operatively, as well as distribution of cadence and of angular velocity. Irregular stepping pattern is indicated by lack of heel strike, large variability in cadence, stride length, and angular velocity as indicated by coefficient of variation. Univariate descriptive statistics and frequency distributions will be calculated, as appropriate for all variables.
Daily step count
时间窗: Up to 22 weeks
Daily step count for the duration of the study will be obtained using the native accelerometer/gyroscope and pedometers available on both iPhone and android devices. Will summarize this complex data using benchmarks of 1, 3, 5, 7, 9 (000 steps) based on meaningful physical activity targets. Will measure the time to achieve these targets post-surgery. These will be captured for the 9 week prehabilitation period and the post-surgery recovery period. As indicated, will focus on steps taken outside of the house as "in house" steps tend to be of very low cadence. For step counts, time to reach the benchmarks of 1, 3, 5, 7, 9 (000 steps) will be calculated and presented descriptively. Univariate descriptive statistics and frequency distributions will be calculated, as appropriate for all variables.
Feasibility as measured by recruitment, retention, adherence, and acceptability
时间窗: Up to 22 weeks
Univariate descriptive statistics and frequency distributions will be calculated, as appropriate for all variables. Baseline values for demographic, clinical, and outcome variables will be tabulated for the treatment groups.
Toronto Extremity Salvage Score
时间窗: At 2, 6, and 12 weeks
This is a self-report measure comprising 30 items (23 for activities of daily living; 7 items for role participation). Will use this measure, completed using observed performance for feasible items and self-report for the remaining items (getting in and out of a car, shopping; driving). Univariate descriptive statistics and frequency distributions will be calculated, as appropriate for all variables. Baseline values for demographic, clinical, and outcome variables will be tabulated for the treatment groups. Between-group effect sizes will be estimated from a mixed model which considers the individual as a cluster with multiple measures per person.
Functional walking capacity
时间窗: At 2, 6, and 12 weeks
Functional walking capacity is defined as walking capacity needed for everyday activities of daily living such as shopping, traveling to and from work, and walking in the workplace or public buildings. The six minute walk test (6MWT) is the gold standard measure for this. The units are distance in meters covered during the test. There is a standardized mobile application for measuring and data comes minute by minute to assess fatigability. Univariate descriptive statistics and frequency distributions will be calculated, as appropriate for all variables.
次要结局
- Global health related quality of life(Up to 22 weeks)
- Symptom status(Up to 22 weeks)