Prehabilitation Soft-Tissue Sarcoma of Lower Limb

Soft Tissue Sarcoma Clinical Trial

Official title:

Starting Recovery Pre-operatively: Feasibility of Implementing Individualized Prehabilitation for People Scheduled for Lower Limb Soft-tissue Sarcoma Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04518488
• Other study ID #: SARC-Prehab (2021-6796)
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2020
• Est. completion date: September 15, 2021

Study information

• Verified date: September 2020
• Source: McGill University
• Contact: Ahmed Abou-Sharkh, MSc
• Phone: 5149341934
• Email: ahmed.abou-sharkh[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: September 15, 2021
• Est. primary completion date: February 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Other:
• Exercises
Personalized and individualized exercises for lower limb soft-tissue sarcoma of each participant in this group.
• Informational Support Group (Control group)
The focus for participants in the Informational Support Group will be on needs for information and psychosocial support during the pre-operative period.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McGill University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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
Primary	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	Change in Edmonton Symptom Assessment Scale	7 symptoms including pain, fatigue, distress, and overall well-being (0-70; 0 better outcome; 70 worst outcome)	Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
Secondary	Change in health related quality of life	Generic Quality of life (EQ-5D-5L)	Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
Secondary	Change in individualized health related quality of life	Patient Generated Index	Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.