- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03916796
Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery
April 4, 2022 updated by: Washington University School of Medicine
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.
Study Overview
Status
Terminated
Conditions
Study Type
Interventional
Enrollment (Actual)
10
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel
|
-The exercise part will consist of an evaluation and treatment as prescribed by a physical therapist including aerobic & dynamic stretching warm-up, strength training, balance training, and flexibility training.
Will also include a home exercise program (HEP).
Physical therapists will have specialized training in cancer rehabilitation obtained through the ReVital certification process.
-The protocols include instructions for patient care from the time of pre-surgical admission to discharge, including directives regarding diet, labs, IV fluids, pain management, prophylactic medications, management of indwelling catheters and drains, and activity.
Other Names:
-The psychological screening will be completed by the Radiation Oncology nurse at the consult visit
-Patients will have a baseline nutrition counseling visit with a Registered Dietician.
This may include a nutrition assessment and nutrition counseling to set priorities, establish goals, and create an individualized plan
|
Experimental: Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel
|
-The exercise part will consist of an evaluation and treatment as prescribed by a physical therapist including aerobic & dynamic stretching warm-up, strength training, balance training, and flexibility training.
Will also include a home exercise program (HEP).
Physical therapists will have specialized training in cancer rehabilitation obtained through the ReVital certification process.
-The protocols include instructions for patient care from the time of pre-surgical admission to discharge, including directives regarding diet, labs, IV fluids, pain management, prophylactic medications, management of indwelling catheters and drains, and activity.
Other Names:
-The psychological screening will be completed by the Radiation Oncology nurse at the consult visit
-Patients will have a baseline nutrition counseling visit with a Registered Dietician.
This may include a nutrition assessment and nutrition counseling to set priorities, establish goals, and create an individualized plan
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of prescribed dietary and physical therapy visits completed during the cancer rehabilitation protocol
Time Frame: Through 3 month follow-up
|
|
Through 3 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of acute treatment-related grade 2 or higher toxicity attributed to the therapy
Time Frame: From baseline through 24 month follow-up
|
From baseline through 24 month follow-up
|
|
Quality of life as measured by the PROMIS Global total score
Time Frame: Change from baseline through 24 month follow-up
|
-PROMIS scales to be used: Physical Function-10, Ability to Participate in Social Roles, Pain Interference, Anxiety and Depression, and Activities-4 and Global Health assessments.
These are validated instruments with items ranked on a 5-point Likert scale.
PROMIS is scored using T scores, which are standardized to the U.S. general population and have a mean of 50 and a standard deviation of 10.
Scores above or below 50 are above or below the population average in the U.S. general population, respectively.
The total T score will be calculated for this outcome measure
|
Change from baseline through 24 month follow-up
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Quality of life as measured by the TESS
Time Frame: Change from baseline through 24 month follow-up
|
-The Toronto Extremity Salvage Score was developed as a measure of patient reported physical functioning for patients undergoing limb salvage surgery for bone and STS
|
Change from baseline through 24 month follow-up
|
Patient cardiovascular capacity as measured by the 6-minute walk test
Time Frame: Change from baseline through 3 month follow-up
|
-This test measures number of meters participants are able to walk in a level setting.
|
Change from baseline through 3 month follow-up
|
Patient general physical health status as measured by 30-second sit to stand test
Time Frame: Change from baseline through 3 month follow-up
|
-The 30 second chair stand test is used to measure functional lower extremity strength and overall endurance.
Participants are asked to go from a sitting position to standing from a chair as many times as they can within 30 seconds.
Higher numbers of sit to stand correlate with increased physical function and lower body strength
|
Change from baseline through 3 month follow-up
|
Patient fall risk as measured by Timed Up and Go test
Time Frame: Change from baseline through 3 month follow-up
|
-The Timed Up and Go is a performance test of physical mobility and fall risk.
The TUG measures how long it takes the patient, in seconds, to stand up from a standard arm chair, walk a distance of 3 meters (approximately 10 feet), turn, walk back to the chair, and sit down again.
Scores of 11 or below are predictive of fall risk
|
Change from baseline through 3 month follow-up
|
Patient general physical health status as measured hand grip strength
Time Frame: Change from baseline through 3 month follow-up
|
-Hand grip strength is measured with the Jamar hydraulic handgrip dynamometer.
Measurement is completed with participant in seated position, holding arm at side, elbow at 90 degrees, and with dynamometer at either second or third position (based on size of hands, smaller hands position 2, larger hands position 3) and participants are encouraged to squeeze as much as possible, 3 times with a minute in between each trial.
Number of pounds strength is recorded along with hand dominance.
This measure is used to record upper body strength
|
Change from baseline through 3 month follow-up
|
Quality of life as measured by the Work Ability Index
Time Frame: Change from baseline through 24 month follow-up
|
-This patient-reported outcome measure asks ability to work on a scale of 0-10 with 0 being unable, and 10 fully able.
It follows with two items asking about reduction in physical and mental work ability due to cancer and its treatment.
Lastly, it asks how many days the participant has been off work.
For this assessment higher scores indicate better levels of work ability
|
Change from baseline through 24 month follow-up
|
Quality of life as measured by the history of previous falls
Time Frame: Change from baseline through 24 month follow-up
|
-Asking patients to report the number of times they've fallen.
Patients who respond they have fallen in the past is correlated to risk of treatment toxicity and risk of future falls
|
Change from baseline through 24 month follow-up
|
Acute wound complication rate
Time Frame: Within first 90 days following surgery
|
-Wound complications include secondary procedures, deep wound packing, readmission to the hospital, wet dressings >4 weeks, or extended dressings >6 weeks.
|
Within first 90 days following surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 31, 2019
Primary Completion (Actual)
August 17, 2021
Study Completion (Actual)
March 18, 2022
Study Registration Dates
First Submitted
April 10, 2019
First Submitted That Met QC Criteria
April 12, 2019
First Posted (Actual)
April 16, 2019
Study Record Updates
Last Update Posted (Actual)
April 12, 2022
Last Update Submitted That Met QC Criteria
April 4, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201904042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Soft Tissue Sarcoma
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OHSU Knight Cancer InstituteNational Cancer Institute (NCI)WithdrawnStage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue Sarcoma | Stage IIA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma
-
National Institutes of Health Clinical Center (CC)CompletedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IVA Adult Soft Tissue Sarcoma | Stage IIB Adult Soft Tissue Sarcoma | Stage IIC Adult Soft Tissue Sarcoma | Stage IVB Adult Soft Tissue Sarcoma
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University of WashingtonAadi Bioscience, Inc.Active, not recruitingAdvanced Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Locally Advanced Soft Tissue SarcomaUnited States
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CytRxUnknownUnresectable Soft Tissue Sarcoma | Metastatic Soft Tissue Sarcoma | Locally Advanced Soft Tissue SarcomaUnited States, Australia, Russian Federation, Hungary, India, Romania, Ukraine
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National Cancer Institute (NCI)RecruitingMetastatic Alveolar Soft Part Sarcoma | Unresectable Alveolar Soft Part Sarcoma | Advanced Soft Tissue Sarcoma | Advanced Alveolar Soft Part SarcomaUnited States
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National Cancer Institute (NCI)TerminatedRecurrent Adult Soft Tissue Sarcoma | Stage III Adult Soft Tissue Sarcoma | Stage IV Adult Soft Tissue Sarcoma | Stage I Adult Soft Tissue Sarcoma | Stage II Adult Soft Tissue SarcomaUnited States
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Centre Leon BerardNovartis; National Cancer Institute, FranceRecruitingAdvanced Soft-tissue Sarcoma | Metastatic Soft-tissue SarcomaFrance
-
UNICANCERRecruitingAdvanced Soft-tissue Sarcoma | Metastatic Soft-tissue SarcomaFrance
-
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