Back to resultsRehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery
Primary Purpose
Soft Tissue Sarcoma
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Enhanced Recovery after surgery
Psychological screening with counselling services as needed
Dietary Counseling Services
Sponsored by
About this trial
This is an interventional supportive care trial for Soft Tissue Sarcoma
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
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel
Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel
Arm Description
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Rate of acute treatment-related grade 2 or higher toxicity attributed to the therapy
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
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
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.
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
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
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
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
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
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.
Full Information
NCT ID
NCT03916796
First Posted
April 10, 2019
Last Updated
April 4, 2022
Sponsor
Washington University School of Medicine
Collaborators
ReVital Cancer Rehabilitation
1. Study Identification
Unique Protocol Identification Number
NCT03916796
Brief Title
Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery
Official Title
Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Too many barriers to enrolling well going forward
Study Start Date
October 31, 2019 (Actual)
Primary Completion Date
August 17, 2021 (Actual)
Study Completion Date
March 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
ReVital Cancer Rehabilitation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Soft Tissue Sarcoma
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel
Arm Type
Experimental
Arm Description
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
Arm Title
Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
-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.
Intervention Type
Other
Intervention Name(s)
Enhanced Recovery after surgery
Other Intervention Name(s)
ERAS
Intervention Description
-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.
Intervention Type
Other
Intervention Name(s)
Psychological screening with counselling services as needed
Intervention Description
-The psychological screening will be completed by the Radiation Oncology nurse at the consult visit
Intervention Type
Other
Intervention Name(s)
Dietary Counseling Services
Intervention Description
-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
Primary Outcome Measure Information:
Title
Percentage of prescribed dietary and physical therapy visits completed during the cancer rehabilitation protocol
Description
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
Time Frame
Through 3 month follow-up
Secondary Outcome Measure Information:
Title
Rate of acute treatment-related grade 2 or higher toxicity attributed to the therapy
Time Frame
From baseline through 24 month follow-up
Title
Quality of life as measured by the PROMIS Global total score
Description
-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
Time Frame
Change from baseline through 24 month follow-up
Title
Quality of life as measured by the TESS
Description
-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
Time Frame
Change from baseline through 24 month follow-up
Title
Patient cardiovascular capacity as measured by the 6-minute walk test
Description
-This test measures number of meters participants are able to walk in a level setting.
Time Frame
Change from baseline through 3 month follow-up
Title
Patient general physical health status as measured by 30-second sit to stand test
Description
-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
Time Frame
Change from baseline through 3 month follow-up
Title
Patient fall risk as measured by Timed Up and Go test
Description
-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
Time Frame
Change from baseline through 3 month follow-up
Title
Patient general physical health status as measured hand grip strength
Description
-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
Time Frame
Change from baseline through 3 month follow-up
Title
Quality of life as measured by the Work Ability Index
Description
-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
Time Frame
Change from baseline through 24 month follow-up
Title
Quality of life as measured by the history of previous falls
Description
-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
Time Frame
Change from baseline through 24 month follow-up
Title
Acute wound complication rate
Description
-Wound complications include secondary procedures, deep wound packing, readmission to the hospital, wet dressings >4 weeks, or extended dressings >6 weeks.
Time Frame
Within first 90 days following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Spraker, M.D., Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery
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