Clinical trial NCT04518488: Prehabilitation Soft-Tissue Sarcoma of Lower Limb
Official title: Starting Recovery Pre-operatively: Feasibility of Implementing Individualized Prehabilitation for People Scheduled for Lower Limb Soft-tissue Sarcoma Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Soft Tissue Sarcoma
Keywords: prehabilitation
walking capacity
gait
quality of life
Lead sponsor: McGill University
Sponsor class: OTHER
First posted: 2020-08-19
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Detailed description: 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. The tumour can be anywhere in the leg so exercises must be specially designed for each person. This process is novel and therefore has to be tested to see if it is practical and if it helps people recovery more quickly. 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. Assessments of how well participants can do basic activities of daily living will be assessed at study entry, just prior to surgery and then at 2, 6 and 12 weeks after surgery. Other measures of recovery will be distance covered while walking for six minutes, quality of the walking, and how quickly participants can walk outdoors for 1000 steps, and then 3000, 5000 and 9000. The investigators will ask participants which of these outcome measures they think best reflected their recovery and why. The investigators will also assess whether people were willing to enter the study and complete all the processes required. 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.

Eligibility criteria: Inclusion Criteria:

* Deep lower extremity Soft-tissue Sarcoma (buttock to foot)
* Histologically or cytologically-proven Soft-tissue Sarcoma (excluding superficial location) of the lower extremity.

Exclusion Criteria:

* Patients with metastatic disease (distant or nodal)
* both and upper and lower extremity involvement

Primary outcomes:
measure: Change in Toronto Extremity Salvage Score
timeFrame: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
measure: Change in Six-Minute Walk Test
timeFrame: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
measure: Daily step count
timeFrame: 12 weeks
measure: Change in Gait Quality (Angular velocity, cadence, heel strike)
timeFrame: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
Secondary outcomes:
measure: Change in Edmonton Symptom Assessment Scale
timeFrame: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
measure: Change in health related quality of life
timeFrame: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
measure: Change in individualized health related quality of life
timeFrame: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
Other outcomes:
Locations:
Study officials:
affiliation: Research Institute - MUHC
name: Nancy Mayo, PhD
role: PRINCIPAL_INVESTIGATOR
References: