Trial Title:
Individualized Prehabilitation for Enhancing Recovery and Surgical Outcomes in Patients Undergoing Radiotherapy and Surgery for Soft Tissue Sarcoma
NCT ID:
NCT05526417
Condition:
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
Conditions: Official terms:
Sarcoma
Coal Tar
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Care Provider)
Masking description:
Masking of treatment assignment to the surgeon and radiation oncologist.
Intervention:
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo CT
Arm group label:
Arm I (prehabilitation physical therapy)
Arm group label:
Arm II (educational materials)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized Tomography
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Other
Intervention name:
Educational Intervention
Description:
Receive educational materials
Arm group label:
Arm I (prehabilitation physical therapy)
Arm group label:
Arm II (educational materials)
Other name:
Education for Intervention
Other name:
Intervention by Education
Other name:
Intervention through Education
Other name:
Intervention, Educational
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Arm I (prehabilitation physical therapy)
Arm group label:
Arm II (educational materials)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Intervention type:
Procedure
Intervention name:
Physical Therapy
Description:
Receive prehabilitation physical therapy
Arm group label:
Arm I (prehabilitation physical therapy)
Other name:
Physiatric Procedure
Other name:
Physical Medicine Procedure
Other name:
Physical Therapeutics
Other name:
Physical Therapy Procedure
Other name:
Physiotherapy
Other name:
Physiotherapy Procedure
Other name:
PT
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Arm I (prehabilitation physical therapy)
Arm group label:
Arm II (educational materials)
Intervention type:
Other
Intervention name:
Telemedicine
Description:
Attend telemedicine visits
Arm group label:
Arm I (prehabilitation physical therapy)
Arm group label:
Arm II (educational materials)
Other name:
Telehealth
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.
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Arizona
Address:
City:
Scottsdale
Zip:
85259
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trial Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Krista A. Goulding, M.D., M.P.H.
Email:
Principal Investigator
Start date:
June 8, 2022
Completion date:
June 8, 2026
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05526417
https://www.mayo.edu/research/clinical-trials
