Prehabilitation Soft-Tissue Sarcoma of Lower Limb

NCT ID: NCT04518488

Last Updated: 2020-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-15
• Study Completion Date: 2021-09-15

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.

Conditions

Soft Tissue Sarcoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Prehabilitation group

The 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.

Group Type: ACTIVE_COMPARATOR

Exercises

Intervention Type: OTHER

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. 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.

Group Type: OTHER

Informational Support Group (Control group)

Intervention Type: OTHER

The focus for participants in the Informational Support Group will be on needs for information and psychosocial support during the pre-operative period.

Interventions

Exercises

Personalized and individualized exercises for lower limb soft-tissue sarcoma of each participant in this group.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nancy Mayo, PhD

Role: PRINCIPAL_INVESTIGATOR

Research Institute - MUHC

Central Contacts

Ahmed Abou-Sharkh, MSc

Role: CONTACT

ahmed.abou-sharkh@mail.mcgill.ca

5149341934 ext. 36922

Nancy Mayo

Role: CONTACT

nancy.mayo@mcgill.ca

5149341934 ext. 36922

Other Identifiers

SARC-Prehab (2021-6796)

Identifier Type: -

Identifier Source: org_study_id