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Prehabilitation Soft-Tissue Sarcoma of Lower Limb

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ClinicalTrials.gov Identifier: NCT04518488
Recruitment Status : Not yet recruiting
First Posted : August 19, 2020
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
McGill University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Soft Tissue Sarcoma Other: Exercises Other: Informational Support Group (Control group) Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Other
Official Title: Starting Recovery Pre-operatively: Feasibility of Implementing Individualized Prehabilitation for People Scheduled for Lower Limb Soft-tissue Sarcoma Surgery
Estimated Study Start Date : September 15, 2020
Estimated Primary Completion Date : February 15, 2021
Estimated Study Completion Date : September 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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.
 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. 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.
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Toronto Extremity Salvage Score [ Time Frame: 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)

  2. Change in Six-Minute Walk Test [ Time Frame: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively. ]
    Walking Capacity

  3. Daily step count [ Time Frame: 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

  4. Change in Gait Quality (Angular velocity, cadence, heel strike) [ Time Frame: 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 Outcome Measures :
  1. Change in Edmonton Symptom Assessment Scale [ Time Frame: 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)

  2. Change in health related quality of life [ Time Frame: 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)

  3. Change in individualized health related quality of life [ Time Frame: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively. ]
    Patient Generated Index


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04518488


Contacts
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Contact: Ahmed Abou-Sharkh, MSc 5149341934 ext 36922 ahmed.abou-sharkh@mail.mcgill.ca
Contact: Nancy Mayo 5149341934 ext 36922 nancy.mayo@mcgill.ca

Sponsors and Collaborators
McGill University
Investigators
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Principal Investigator: Nancy Mayo, PhD Research Institute - MUHC
More Information
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Responsible Party: McGill University
ClinicalTrials.gov Identifier: NCT04518488    
Other Study ID Numbers: SARC-Prehab (2021-6796)
First Posted: August 19, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by McGill University:
prehabilitation
walking capacity
gait
quality of life
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms