Prehabilitation and Enhanced Recovery After Surgery to Improve Acute Wound Healing Complications in Soft Tissue Sarcoma Treated With Neoadjuvant Radiotherapy
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|ClinicalTrials.gov Identifier: NCT03916796|
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : February 17, 2020
This study is designed as a lead-in adherence study evaluating feasibility followed by full pilot evaluating the prehabiliation and ERAS protocols. This study will first assess a 5-patient lead-in cohort to determine if patients adequately adhere to the prehabilitation protocol. If successful, the study will proceed with a full pilot of the multimodal prehabiliation protocol.
Prehabilitation is not well studied in the STS population. As such, a secondary goal of this study will be to determine the effects of the multi-modal prehabilitation and ERAS protocols on physical function and quality of life outcomes.
|Condition or disease||Intervention/treatment||Phase|
|Soft Tissue Sarcoma||Other: Exercise Other: Enhanced Recovery after surgery Other: Psychological screening with counselling services as needed Other: Dietary Counseling Services||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Prehabilitation and Enhanced Recovery After Surgery to Improve Acute Wound Healing Complications in Soft Tissue Sarcoma Treated With Neoadjuvant Radiotherapy|
|Actual Study Start Date :||October 31, 2019|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Dietary Counseling/Exercise/ERAS/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.
Other: 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.
Other Name: ERAS
Other: Psychological screening with counselling services as needed
-The psychological screening will be completed by the Radiation Oncology nurse at the consult visit
Other: 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
- Percentage of prescribed dietary and physical therapy visits completed during the prehabilitation period [ Time Frame: Within 90 days following surgery ]-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.
- Rate of acute treatment-related grade 2 or higher toxicity attributed to the therapy [ Time Frame: From baseline through 90 days after surgery ]
- Quality of life as measured by the PROMIS Global total score [ Time Frame: Change from baseline through 90 day 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
- Quality of life as measured by the TESS [ Time Frame: Change from baseline through 90 day 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
- Patient cardiovascular capacity as measured by the 6-minute walk test [ Time Frame: Change from baseline through 90 day follow-up ]-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 [ Time Frame: Change from baseline through 90 day 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
- Patient fall risk as measured by Timed Up and Go test [ Time Frame: Change from baseline through 90 day 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
- Patient general physical health status as measured hand grip strength [ Time Frame: Change from baseline through 90 day 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
- Quality of life as measured by the Work Ability Index [ Time Frame: Change from baseline through 90 day 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
- Quality of life as measured by the history of previous falls [ Time Frame: Change from baseline through 90 day follow-up ]-Asking patients to report the number of times they've fallen in the last 6 months. 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 [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916796
|Contact: Matthew Spraker, M.D., Ph.D.||email@example.com|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|Contact: Matthew Spraker, M.D., Ph.D. 314-362-8567 firstname.lastname@example.org|
|Principal Investigator: Matthew Spraker, M.D., Ph.D.|
|Sub-Investigator: Brian Van Tine, M.D.|
|Sub-Investigator: Angela Hirbe, M.D.|
|Sub-Investigator: Peter Oppelt, M.D.|
|Sub-Investigator: Brian Baumann, M.D.|
|Sub-Investigator: Jeff Michalski, M.D.|
|Sub-Investigator: Leping Wan, MPH|
|Sub-Investigator: Cara Cipriano, M.D.|
|Sub-Investigator: Douglas McDonald, M.D.|
|Sub-Investigator: Regis O'Keefe, M.D.|
|Sub-Investigator: Nate Olafsen, M.D.|
|Principal Investigator:||Matthew Spraker, M.D., Ph.D.||Washington University School of Medicine|