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Too many barriers to enrolling well going forward
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| Name | Class |
|---|---|
| ReVital Cancer Rehabilitation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pre-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel | Experimental |
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| Post-Operative Radiotherapy: Dietary Counseling/Exercise/Psychological Counsel | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise | Other | -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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of prescribed dietary and physical therapy visits completed during the cancer rehabilitation protocol |
| Through 3 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | -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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Spraker, M.D., Ph.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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|
| Enhanced Recovery after surgery | Other | -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. |
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| Psychological screening with counselling services as needed | Other | -The psychological screening will be completed by the Radiation Oncology nurse at the consult visit |
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| Dietary Counseling Services | Other | -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 |
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| 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 | 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. | 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 | 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 | 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 | 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 | 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 | 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. | Within first 90 days following surgery |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| D000080482 | Enhanced Recovery After Surgery |
| D006301 | Health Services Needs and Demand |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D019990 | Perioperative Care |
| D013514 | Surgical Procedures, Operative |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D003695 | Delivery of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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