Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery

Soft Tissue Sarcoma Clinical Trial

Official title:

Rehabilitation and Quality of Life Assessment for Soft Tissue Sarcoma Treated With Radiotherapy and Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03916796
• Other study ID #: 201904042
• Status: Terminated
• Phase: N/A
• Start date: October 31, 2019
• Est. completion date: March 18, 2022

Study information

• Verified date: April 2022
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). At enrollment, patients will be assigned to either a pre-operative radiation or post-operative radiation cohort.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: March 18, 2022
• Est. primary completion date: August 17, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	ReVital Cancer Rehabilitation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Through 3 month follow-up
Secondary	Rate of acute treatment-related grade 2 or higher toxicity attributed to the therapy		From baseline through 24 month follow-up
Secondary	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	Change from baseline through 24 month follow-up
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine