Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery
NCT ID: NCT03916796
Last Updated: 2022-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
10 participants
INTERVENTIONAL
2019-10-31
2022-03-18
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel
* 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
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.
Enhanced Recovery after surgery
-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 needed
-The psychological screening will be completed by the Radiation Oncology nurse at the consult visit
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
Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel
* 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
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.
Enhanced Recovery after surgery
-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 needed
-The psychological screening will be completed by the Radiation Oncology nurse at the consult visit
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
Interventions
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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.
Enhanced Recovery after surgery
-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 needed
-The psychological screening will be completed by the Radiation Oncology nurse at the consult visit
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
14 Years
ALL
No
Sponsors
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ReVital Cancer Rehabilitation
UNKNOWN
Washington University School of Medicine
OTHER
Responsible Party
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Principal Investigators
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Matthew Spraker, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Washington University School of Medicine
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Related Links
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Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Other Identifiers
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201904042
Identifier Type: -
Identifier Source: org_study_id
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