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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-08

Study Completion Date

2026-06-08

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Caregivers

Masking of treatment assignment to the surgeon and radiation oncologist.

Study Groups

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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.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Educational Intervention

Intervention Type OTHER

Receive educational materials

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Physical Therapy

Intervention Type PROCEDURE

Receive prehabilitation physical therapy

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Telemedicine

Intervention Type OTHER

Attend telemedicine visits

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.

Group Type ACTIVE_COMPARATOR

Computed Tomography

Intervention Type PROCEDURE

Undergo CT

Educational Intervention

Intervention Type OTHER

Receive educational materials

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MRI

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Telemedicine

Intervention Type OTHER

Attend telemedicine visits

Interventions

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Computed Tomography

Undergo CT

Intervention Type PROCEDURE

Educational Intervention

Receive educational materials

Intervention Type OTHER

Magnetic Resonance Imaging

Undergo MRI

Intervention Type PROCEDURE

Physical Therapy

Receive prehabilitation physical therapy

Intervention Type PROCEDURE

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Telemedicine

Attend telemedicine visits

Intervention Type OTHER

Other Intervention Names

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CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized Tomography CT CT Scan tomography Education for Intervention Intervention by Education Intervention through Education Intervention, Educational Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR MR Imaging MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Physiatric Procedure Physical Medicine Procedure Physical Therapeutics Physical Therapy Procedure Physiotherapy Physiotherapy Procedure PT Telehealth

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No