Идёт набор NCT05526417

Individualized Prehabilitation for Enhancing Recovery and Surgical Outcomes in Patients Undergoing Radiotherapy and Surgery for Soft Tissue Sarcoma

Без фазы С лечением Soft Tissue Sarcoma Stage I Soft Tissue Sarcoma of the Trunk and Extremities Stage II Soft Tissue Sarcoma of the Trunk and Extremities Stage III Soft Tissue Sarcoma of the Trunk and Extremities

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Computed Tomography, Educational Intervention, Magnetic Resonance Imaging, Physical Therapy.
Кому может быть актуально: Состояния в реестре: Soft Tissue Sarcoma, Stage I Soft Tissue Sarcoma of the Trunk and Extremities, Stage II Soft Tissue Sarcoma of the Trunk and Extremities, Stage III Soft Tissue Sarcoma of the Trunk and Extremities. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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:

I. To compare changes in quality of life over time as a result of the prehabilitation intervention using the Edmonton Symptom Assessment Scale (ESAS), European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D-5L) (Euroqol Group), the Patient Generated Index (PGI).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients perform personalized prehabilitation physical therapy exercises twice a day (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 magnetic resonance imaging (MRI) and computed tomography (CT) at week 9.

ARM II: 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 prior to standard of care surgery. Patients undergo MRI and CT at week 9.

After completion of study, patients are followed up at weeks 2, 6, and 12.

Вмешательства

Процедура Computed Tomography
Undergo CT
Другое Educational Intervention
Receive educational materials
Процедура Magnetic Resonance Imaging
Undergo MRI
Процедура Physical Therapy
Receive prehabilitation physical therapy
Другое Questionnaire Administration
Ancillary studies
Другое Telemedicine
Attend telemedicine visits

Первичные конечные точки

Feasibility as measured by recruitment, retention, adherence, and acceptability [Срок оценки: Up to 22 weeks]
Efficacy potential [Срок оценки: Up to 22 weeks]
Toronto Extremity Salvage Score [Срок оценки: At 2, 6, and 12 weeks]
Functional walking capacity [Срок оценки: At 2, 6, and 12 weeks]
Gait quality [Срок оценки: Up to 22 weeks]
Daily step count [Срок оценки: Up to 22 weeks]

Вторичные конечные точки (2)

Symptom status [Срок оценки: Up to 22 weeks]
Global health related quality of life [Срок оценки: Up to 22 weeks]

Критерии участия

Критерии включения

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