Prehabilitation Soft-Tissue Sarcoma of Lower Limb
Starting Recovery Pre-operatively: Feasibility of Implementing Individualized Prehabilitation for People Scheduled for Lower Limb Soft-tissue Sarcoma Surgery
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
This study is about preparing people with cancerous tumours, soft-tissue sarcoma (STS), in the leg to recover more quickly from surgery. Prehabilitation or "surgery school" is done before surgery while undergoing other cancer-related treatments. To test this idea, two groups will be formed. One group will have the prehabilitation program and the other group will have the same amount of attention from the research team who will visit them at the time of the radiotherapy sessions to provide support and any information they may need.The results of the study will indicate whether it is a good idea to conduct a bigger study that would involve many centres in Canada.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2020
CompletedFirst Posted
Study publicly available on registry
August 19, 2020
CompletedStudy Start
First participant enrolled
September 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2021
CompletedSeptember 21, 2020
September 1, 2020
5 months
July 29, 2020
September 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Change in Toronto Extremity Salvage Score
self-report measure comprising 30 items (0-100; 0 worse, 100 better outcome)
Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
Change in Six-Minute Walk Test
Walking Capacity
Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
Daily step count
will be obtained using the native accelerometer/gyroscope and pedometers available on both iphone (iOS) and android devices. For example, the android connection is through Google Fit
12 weeks
Change in Gait Quality (Angular velocity, cadence, heel strike)
Obtained through device placed on the shoe of participants
Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
Secondary Outcomes (3)
Change in Edmonton Symptom Assessment Scale
Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
Change in health related quality of life
Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
Change in individualized health related quality of life
Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
Study Arms (2)
Prehabilitation group
ACTIVE COMPARATORThe prehabilitation group will receive a set of exercises designed to strengthen both limbs. The exercises will be taught and illustrated by a trained physiotherapist and are to be done daily during the period prior to surgery. The participant will be coached and supported for the exercise program, twice a week during the pre-operative period.
Informational support group (control group)
OTHERThe focus for participants in the Informational Support Group will be on needs for information and psychosocial support during the pre-operative period. The intervention will be in the form of telephone or video calls by a trained health professional. These calls will be scheduled twice a week during the pre-operative period.
Interventions
Personalized and individualized exercises for lower limb soft-tissue sarcoma of each participant in this group.
The focus for participants in the Informational Support Group will be on needs for information and psychosocial support during the pre-operative period.
Eligibility Criteria
You may qualify if:
- Deep lower extremity Soft-tissue Sarcoma (buttock to foot)
- Histologically or cytologically-proven Soft-tissue Sarcoma (excluding superficial location) of the lower extremity.
You may not qualify if:
- Patients with metastatic disease (distant or nodal)
- both and upper and lower extremity involvement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nancy Mayo, PhD
Research Institute - MUHC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2020
First Posted
August 19, 2020
Study Start
September 15, 2020
Primary Completion
February 15, 2021
Study Completion
September 15, 2021
Last Updated
September 21, 2020
Record last verified: 2020-09