Individualized Prehabilitation for Enhancing Recovery and Surgical Outcomes in Patients Undergoing Radiotherapy and Surgery for Soft Tissue Sarcoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Computed Tomography, Educational Intervention, Magnetic Resonance Imaging, Physical Therapy.
- Who it may be relevant to
- Registry conditions: 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. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Interventions
- Procedure Computed Tomography
Undergo CT - Other Educational Intervention
Receive educational materials - Procedure Magnetic Resonance Imaging
Undergo MRI - Procedure Physical Therapy
Receive prehabilitation physical therapy - Other Questionnaire Administration
Ancillary studies - Other Telemedicine
Attend telemedicine visits
Primary outcome measures
- Feasibility as measured by recruitment, retention, adherence, and acceptability [Time frame: Up to 22 weeks]
- Efficacy potential [Time frame: Up to 22 weeks]
- Toronto Extremity Salvage Score [Time frame: At 2, 6, and 12 weeks]
- Functional walking capacity [Time frame: At 2, 6, and 12 weeks]
- Gait quality [Time frame: Up to 22 weeks]
- Daily step count [Time frame: Up to 22 weeks]
Secondary outcome measures (2)
- Symptom status [Time frame: Up to 22 weeks]
- Global health related quality of life [Time frame: Up to 22 weeks]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Mayo Clinic in Arizona — Scottsdale
Identifiers
NCT: NCT05526417 · GMROA2182 · NCI-2022-05583 · 21-002674