Soft Tissue Sarcoma
Conditions
Keywords
prehabilitation, walking capacity, gait, quality of life
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.
Interventions
OTHERExercises
Personalized and individualized exercises for lower limb soft-tissue sarcoma of each participant in this group.
OTHERInformational 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.
Sponsors
McGill University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Toronto Extremity Salvage Score | Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively. | self-report measure comprising 30 items (0-100; 0 worse, 100 better outcome) |
| Change in Six-Minute Walk Test | Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively. | Walking Capacity |
| Daily step count | 12 weeks | 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 |
| Change in Gait Quality (Angular velocity, cadence, heel strike) | Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively. | Obtained through device placed on the shoe of participants |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Generic Quality of life (EQ-5D-5L) |
| 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. | Patient Generated Index |
| 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. | 7 symptoms including pain, fatigue, distress, and overall well-being (0-70; 0 better outcome; 70 worst outcome) |
Contacts
Primary ContactAhmed Abou-Sharkh, MSc
Backup ContactNancy Mayo
Outcome results
None listed