About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically-proven deep soft tissue sarcoma (STS) of the lower extremity
Localized
Adults, 18 and older
All gender types
Disqualifiers
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
Parallel
Treatments tested in this trial
Computed Tomography
Procedure/SurgeryUndergo CT
Educational Intervention
Other interventionReceive educational materials
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Physical Therapy
Procedure/SurgeryReceive prehabilitation physical therapy
Questionnaire Administration
Other interventionAncillary studies
Telemedicine
Other interventionAttend telemedicine visits
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
Symptom status
Symptom status will be assessed using the Edmonton Symptom Assessment Scale which assesses 7 symptoms including pain, fatigue, distress, and overall well-being. Univariate descriptive statistics and frequency distributions will be calculated, as appropriate for all variables.
Global health related quality of life
Global health related quality of life will be measured using the 5-level EQ-5D version (Euroqol Group) and the Patient Generated Index will be used to assess quality of life. Univariate descriptive statistics and frequency distributions will be calculated, as appropriate for all variables.
Sponsors and contacts
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