Prehabilitation Soft-Tissue Sarcoma of Lower Limb

McGill University

Status: Unknown

Conditions: Soft Tissue Sarcoma

Treatments: Other: Exercises; Other: Informational Support Group (Control group)

Study type: Interventional

Funder types: Other

Identifiers

NCT04518488

SARC-Prehab (2021-6796)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

Prehabilitation group

Active Comparator group

Description:

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.

Treatment:

Other: Exercises

Informational support group (control group)

Other group

Description:

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.

Treatment:

Other: Informational Support Group (Control group)