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

NCT05526417 | Recruiting

• 3 other identifiers: GMROA2182NCI-2022-0558321-002674
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (6)

• Feasibility as measured by recruitment, retention, adherence, and acceptability

  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.

  Up to 22 weeks

• Efficacy potential

  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.

  Up to 22 weeks

• Toronto Extremity Salvage Score

  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.

  At 2, 6, and 12 weeks

• Functional walking capacity

  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.

  At 2, 6, and 12 weeks

• Gait quality

  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.

  Up to 22 weeks

• Daily step count

  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.

  Up to 22 weeks

Secondary Outcomes (2)

• Symptom status

  Up to 22 weeks

• Global health related quality of life

  Up to 22 weeks

Study Arms (2)

Arm I (prehabilitation physical therapy)

EXPERIMENTAL

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.

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

Arm II (educational materials)

ACTIVE COMPARATOR

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.

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

Interventions

Educational Intervention OTHER

Receive educational materials

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Arm I (prehabilitation physical therapy); Arm II (educational materials)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging

Arm I (prehabilitation physical therapy); Arm II (educational materials)

Physical Therapy PROCEDURE

Receive prehabilitation physical therapy

Also known as: Physiatric Procedure, Physical Medicine Procedure, Physical Therapeutics, Physical Therapy Procedure, Physiotherapy, Physiotherapy Procedure, PT

Arm I (prehabilitation physical therapy)

Questionnaire Administration OTHER

Ancillary studies

Arm I (prehabilitation physical therapy); Arm II (educational materials)

Telemedicine OTHER

Attend telemedicine visits

Also known as: Telehealth

Arm I (prehabilitation physical therapy); Arm II (educational materials)

Computed Tomography PROCEDURE

Undergo CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography

Arm I (prehabilitation physical therapy); Arm II (educational materials)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Sarcoma

Interventions

Early Intervention, Educational; Educational Status; Methods; Magnetic Resonance Spectroscopy; Physical Therapy Modalities; Telemedicine

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical; Therapeutics; Rehabilitation; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Krista A. Goulding, MD, MPH

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Masking of treatment assignment to the surgeon and radiation oncologist.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: June 8, 2022
• Primary Completion (Estimated): June 8, 2026
• Study Completion (Estimated): June 8, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Locations

US (1)