Soft Tissue SarcomaNCT03916796
Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery
A study testing Exercise, Enhanced Recovery after surgery and Psychological screening with counselling services as needed in people with Soft Tissue Sarcoma, run by Washington University School of Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Exercise, Enhanced Recovery after surgery and Psychological screening with counselling services as needed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2019to 18 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
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.
- Conditions
- Soft Tissue Sarcoma
- Being tested
- Exercise, Enhanced Recovery after surgery, Psychological screening with counselling services as needed, Dietary Counseling Services
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
-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.
Enhanced Recovery after surgeryOther
Also called ERAS
-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.
Psychological screening with counselling services as neededOther
-The psychological screening will be completed by the Radiation Oncology nurse at the consult visit
Dietary Counseling ServicesOther
-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
| Study group | Role | What they receive |
|---|---|---|
| Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel | Experimental | * Patients must be treated using daily image-guided radiotherapy
* Dietary counseling at baseline
* Exercise intervention throughout cancer rehabilitation protocol
* Psychological screening with counselling services as needed - nurse will administer the NCCN distress thermometer and refer the patient to applicable psychological counselling Receives: Other: Exercise; Other: Enhanced Recovery after surgery; Other: Psychological screening with counselling services as needed; Other: Dietary Counseling Services |
| Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel | Experimental | * Patients must be treated using daily image-guided radiotherapy
* Dietary counseling at baseline
* Exercise intervention throughout cancer rehabilitation protocol
* Psychological screening with counselling services as needed - nurse will administer the NCCN distress thermometer and refer the patient to applicable psychological counselling Receives: Other: Exercise; Other: Enhanced Recovery after surgery; Other: Psychological screening with counselling services as needed; Other: Dietary Counseling Services |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of prescribed dietary and physical therapy visits completed during the cancer rehabilitation protocol
- 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
Measured: Through 3 month follow-up
Secondary outcomes (10)
Rate of acute treatment-related grade 2 or higher toxicity attributed to the therapy
Measured: From baseline through 24 month follow-up
Quality of life as measured by the PROMIS Global total score
-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
Measured: Change from baseline through 24 month follow-up
Quality of life as measured by the TESS
-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
Measured: Change from baseline through 24 month follow-up
Patient cardiovascular capacity as measured by the 6-minute walk test
-This test measures number of meters participants are able to walk in a level setting.
Measured: Change from baseline through 3 month follow-up
Patient general physical health status as measured by 30-second sit to stand test
-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
Measured: Change from baseline through 3 month follow-up
Patient fall risk as measured by Timed Up and Go test
-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
Measured: Change from baseline through 3 month follow-up
Patient general physical health status as measured hand grip strength
-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
Measured: Change from baseline through 3 month follow-up
Quality of life as measured by the Work Ability Index
-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
Measured: Change from baseline through 24 month follow-up
Quality of life as measured by the history of previous falls
-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
Measured: Change from baseline through 24 month follow-up
Acute wound complication rate
-Wound complications include secondary procedures, deep wound packing, readmission to the hospital, wet dressings >4 weeks, or extended dressings >6 weeks.
Measured: Within first 90 days following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start31 Oct 2019
- Primary completion17 Aug 2021
- Study completion18 Mar 2022
Why it stopped: Too many barriers to enrolling well going forward
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- ReVital Cancer Rehabilitation
- Responsible party
- Sponsor
- Investigators
- Matthew Spraker, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03916796
- Sponsor's protocol ID
- 201904042
- Status last verified
- Apr 2022
- First submitted
- 10 Apr 2019
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery
- ClinicalTrials.gov ID
- NCT03916796
- Acronym / sponsor ID
- 201904042
- Conditions
- Soft Tissue Sarcoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too many barriers to enrolling well going forward
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- ReVital Cancer Rehabilitation
- Study start
- 31 Oct 2019 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel | Experimental | Other: Exercise, Other: Enhanced Recovery after surgery, Other: Psychological screening with counselling services as needed, Other: Dietary Counseling Services* Patients must be treated using daily image-guided radiotherapy * Dietary counseling at baseline * Exercise intervention throughout cancer rehabilitation protocol * Psychological screening with counselling services as needed - nurse will administer the NCCN distress thermometer and refer the patient to applicable psychological counselling |
| Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel | Experimental | Other: Exercise, Other: Enhanced Recovery after surgery, Other: Psychological screening with counselling services as needed, Other: Dietary Counseling Services* Patients must be treated using daily image-guided radiotherapy * Dietary counseling at baseline * Exercise intervention throughout cancer rehabilitation protocol * Psychological screening with counselling services as needed - nurse will administer the NCCN distress thermometer and refer the patient to applicable psychological counselling |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise-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. | Other | Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel, Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel |
| Enhanced Recovery after surgeryAlso: ERAS-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 | Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel, Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel |
| Psychological screening with counselling services as needed-The psychological screening will be completed by the Radiation Oncology nurse at the consult visit | Other | Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel, Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel |
| Dietary Counseling Services-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 | Other | Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel, Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel |
Primary outcome
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
10 secondary outcomes
Rate of acute treatment-related grade 2 or higher toxicity attributed to the therapy
Time frame: 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
Quality of life as measured by the TESS
Time frame: 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
Patient general physical health status as measured by 30-second sit to stand test
Time frame: 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
Patient general physical health status as measured hand grip strength
Time frame: 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
Quality of life as measured by the history of previous falls
Time frame: Change from baseline through 24 month follow-up
Acute wound complication rate
Time frame: Within first 90 days following surgery
Results and safety
The study was stopped early (reason given: Too many barriers to enrolling well going forward). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Spraker, M.D., Ph.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise, Enhanced Recovery after surgery and Psychological screening with counselling services as needed in people with Soft Tissue Sarcoma, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Too many barriers to enrolling well going forward). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of prescribed dietary and physical therapy visits completed during the cancer rehabilitation protocol (time frame: Through 3 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2022; AzTrials last refreshed its copy on 8 Nov 2026.