search
Back to results

Prehabilitation Soft-Tissue Sarcoma of Lower Limb

Primary Purpose

Soft Tissue Sarcoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercises
Informational Support Group (Control group)
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Soft Tissue Sarcoma focused on measuring prehabilitation, walking capacity, gait, quality of life

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Other

    Arm Label

    Prehabilitation group

    Informational support group (control group)

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Change in Toronto Extremity Salvage Score
    self-report measure comprising 30 items (0-100; 0 worse, 100 better outcome)
    Change in Six-Minute Walk Test
    Walking Capacity
    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
    Change in Gait Quality (Angular velocity, cadence, heel strike)
    Obtained through device placed on the shoe of participants

    Secondary Outcome Measures

    Change in Edmonton Symptom Assessment Scale
    7 symptoms including pain, fatigue, distress, and overall well-being (0-70; 0 better outcome; 70 worst outcome)
    Change in health related quality of life
    Generic Quality of life (EQ-5D-5L)
    Change in individualized health related quality of life
    Patient Generated Index

    Full Information

    First Posted
    July 29, 2020
    Last Updated
    September 17, 2020
    Sponsor
    McGill University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT04518488
    Brief Title
    Prehabilitation Soft-Tissue Sarcoma of Lower Limb
    Official Title
    Starting Recovery Pre-operatively: Feasibility of Implementing Individualized Prehabilitation for People Scheduled for Lower Limb Soft-tissue Sarcoma Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 15, 2020 (Anticipated)
    Primary Completion Date
    February 15, 2021 (Anticipated)
    Study Completion Date
    September 15, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McGill University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Soft Tissue Sarcoma
    Keywords
    prehabilitation, walking capacity, gait, quality of life

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prehabilitation group
    Arm Type
    Active Comparator
    Arm 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.
    Arm Title
    Informational support group (control group)
    Arm Type
    Other
    Arm 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.
    Intervention Type
    Other
    Intervention Name(s)
    Exercises
    Intervention Description
    Personalized and individualized exercises for lower limb soft-tissue sarcoma of each participant in this group.
    Intervention Type
    Other
    Intervention Name(s)
    Informational Support Group (Control group)
    Intervention Description
    The focus for participants in the Informational Support Group will be on needs for information and psychosocial support during the pre-operative period.
    Primary Outcome Measure Information:
    Title
    Change in Toronto Extremity Salvage Score
    Description
    self-report measure comprising 30 items (0-100; 0 worse, 100 better outcome)
    Time Frame
    Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
    Title
    Change in Six-Minute Walk Test
    Description
    Walking Capacity
    Time Frame
    Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
    Title
    Daily step count
    Description
    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
    Time Frame
    12 weeks
    Title
    Change in Gait Quality (Angular velocity, cadence, heel strike)
    Description
    Obtained through device placed on the shoe of participants
    Time Frame
    Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
    Secondary Outcome Measure Information:
    Title
    Change in Edmonton Symptom Assessment Scale
    Description
    7 symptoms including pain, fatigue, distress, and overall well-being (0-70; 0 better outcome; 70 worst outcome)
    Time Frame
    Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
    Title
    Change in health related quality of life
    Description
    Generic Quality of life (EQ-5D-5L)
    Time Frame
    Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
    Title
    Change in individualized health related quality of life
    Description
    Patient Generated Index
    Time Frame
    Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahmed Abou-Sharkh, MSc
    Phone
    5149341934
    Ext
    36922
    Email
    ahmed.abou-sharkh@mail.mcgill.ca
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nancy Mayo
    Phone
    5149341934
    Ext
    36922
    Email
    nancy.mayo@mcgill.ca
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nancy Mayo, PhD
    Organizational Affiliation
    Research Institute - MUHC
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Prehabilitation Soft-Tissue Sarcoma of Lower Limb

    We'll reach out to this number within 24 hrs