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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Mayo Clinic
Study ID
NCT05526417
Status
Recruiting
Apply to this trial

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jun 8, 2022
Status verified
Jan 2026
Primary completion
Jun 8, 2026
Completion
Jun 8, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • Active Comparator: 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.

Primary Outcome Measure

Feasibility as measured by recruitment, retention, adherence, and acceptability [ Time Frame: Up to 22 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259
Clinical Trial Referral Office
[email protected]
855-776-0015
Krista A. Goulding, MD, MPH (PRINCIPAL_INVESTIGATOR)

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