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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Educational Intervention

    Other intervention

    Receive educational materials

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Physical Therapy

    Procedure/Surgery

    Receive prehabilitation physical therapy

  • Questionnaire Administration

    Other intervention

    Ancillary studies

  • Telemedicine

    Other intervention

    Attend telemedicine visits

Treatment groups

33 Participants
are divided into 2 treatment groups
Group A: Arm I (prehabilitation physical therapy)Experimental treatment 6 interventions
Group B: Arm II (educational materials)Active comparator 5 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Up to 22 weeks
2

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.

Time frame
Up to 22 weeks
3

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.

Time frame
At 2, 6, and 12 weeks
4

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.

Time frame
At 2, 6, and 12 weeks

Secondary outcomes

1

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.

Time frame
Up to 22 weeks
2

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.

Time frame
Up to 22 weeks

Other outcomes

Sponsors and contacts

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