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

Mayo Clinic

Status: Enrolling

Conditions: Stage I Soft Tissue Sarcoma of the Trunk and Extremities; Soft Tissue Sarcoma; Stage II Soft Tissue Sarcoma of the Trunk and Extremities; Stage III Soft Tissue Sarcoma of the Trunk and Extremities

Treatments: Other: Questionnaire Administration; Other: Telemedicine; Procedure: Magnetic Resonance Imaging; Other: Educational Intervention; Procedure: Physical Therapy; Procedure: Computed Tomography

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05526417

NCI-2022-05583 (Registry Identifier)

GMROA2182 (Other Identifier)

21-002674 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Arm I (prehabilitation physical therapy)

Experimental group

Description:

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.

Treatment:

Procedure: Computed Tomography

Procedure: Physical Therapy

Other: Educational Intervention

Procedure: Magnetic Resonance Imaging

Other: Telemedicine

Other: Questionnaire Administration

Arm II (educational materials)

Active Comparator group

Description:

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.

Treatment:

Procedure: Computed Tomography

Other: Educational Intervention

Procedure: Magnetic Resonance Imaging

Other: Telemedicine

Other: Questionnaire Administration