Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery

Washington University School of Medicine1 site in 1 country10 target enrollmentOctober 31, 2019

ConditionsSoft Tissue Sarcoma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Soft Tissue Sarcoma
Sponsor: Washington University School of Medicine
Enrollment: 10
Locations: 1
Primary Endpoint: Percentage of prescribed dietary and physical therapy visits completed during the cancer rehabilitation protocol
Status: Terminated
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a pilot study with a feasibility lead-in evaluating the use of multimodal cancer rehabilitation in patients planning to undergo radiotherapy and surgical resection for extremity or superficial trunk soft tissue sarcoma (STS). At enrollment, patients will be assigned to either a pre-operative radiation or post-operative radiation cohort.

Registry

clinicaltrials.gov

Start Date

October 31, 2019

End Date

March 18, 2022

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Washington University School of Medicine

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically or cytologically confirmed soft tissue sarcoma of the extremity, or superficial trunk (abdomen or chest)
•Planning to receive radiotherapy and surgical resection
•At least 16 years of age.
•ECOG performance status ≤ 3
•Able to complete the cancer rehabilitation protocol safely, as determined by a treating physician.
•Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).

Exclusion Criteria

•Patients deemed ineligible for curative therapy by the treating medical oncologist, radiation oncologist, or surgeon.
•Patients with deep retroperitoneal or abdominal STS
•Patients who have received prior radiotherapy and, based on the treating radiation oncologist's opinion, may not safely be treated with protocol neoadjuvant radiotherapy.
•Currently receiving any investigational agents.
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
•Pregnant and/or breastfeeding. Women of childbearing potential must have a negative pregnancy test prior to starting radiotherapy.
•HIV-positive patients whose CD4+ T-cell count is \< 350 cells/mcL.
•Receiving concurrent chemoradiation therapy

Outcomes

Primary Outcomes

Percentage of prescribed dietary and physical therapy visits completed during the cancer rehabilitation protocol

Time Frame: Through 3 month follow-up

* This will be quantified as the proportion of prescribed visits within the prehabilitation protocol that are attended by the patient. If a patient participates in any portion of a prescribed visit, it will be counted as attended. * Physical therapy visits are optional from 6 months-24 months

Secondary Outcomes

Rate of acute treatment-related grade 2 or higher toxicity attributed to the therapy(From baseline through 24 month follow-up)
Quality of life as measured by the PROMIS Global total score(Change from baseline through 24 month follow-up)
Patient fall risk as measured by Timed Up and Go test(Change from baseline through 3 month follow-up)
Acute wound complication rate(Within first 90 days following surgery)
Patient general physical health status as measured hand grip strength(Change from baseline through 3 month follow-up)
Quality of life as measured by the Work Ability Index(Change from baseline through 24 month follow-up)
Quality of life as measured by the history of previous falls(Change from baseline through 24 month follow-up)
Quality of life as measured by the TESS(Change from baseline through 24 month follow-up)
Patient cardiovascular capacity as measured by the 6-minute walk test(Change from baseline through 3 month follow-up)
Patient general physical health status as measured by 30-second sit to stand test(Change from baseline through 3 month follow-up)