Soft Tissue SarcomaNCT04518488
Prehabilitation Soft-Tissue Sarcoma of Lower Limb
A study testing Exercises in people with Soft Tissue Sarcoma, run by McGill University.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Soft Tissue Sarcoma
- What is being tested?
- Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Sep 2020to 15 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Deep lower extremity Soft-tissue Sarcoma (buttock to foot)
- Histologically or cytologically-proven Soft-tissue Sarcoma (excluding superficial location) of the lower extremity.
Who cannot join
- Patients with metastatic disease (distant or nodal)
- both and upper and lower extremity involvement
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Starting Recovery Pre-operatively: Feasibility of Implementing Individualized Prehabilitation for People Scheduled for Lower Limb Soft-tissue Sarcoma Surgery
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.
Read the 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
- Being tested
- Exercises, Informational Support Group (Control group)
- Keywords
- prehabilitation, walking capacity, gait, quality of life
- Medical subject headings
- Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExercisesOther
Personalized and individualized exercises for lower limb soft-tissue sarcoma of each participant in this group.
Informational Support Group (Control group)Other
The focus for participants in the Informational Support Group will be on needs for information and psychosocial support during the pre-operative period.
| Study group | Role | What they receive |
|---|---|---|
| Prehabilitation group | Active comparator | 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. Receives: Other: Exercises |
| Informational support group (control group) | Other | 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. Receives: Other: Informational Support Group (Control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Toronto Extremity Salvage Score
self-report measure comprising 30 items (0-100; 0 worse, 100 better outcome)
Measured: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
Change in Six-Minute Walk Test
Walking Capacity
Measured: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
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
Measured: 12 weeks
Change in Gait Quality (Angular velocity, cadence, heel strike)
Obtained through device placed on the shoe of participants
Measured: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
Secondary outcomes (3)
Change in Edmonton Symptom Assessment Scale
7 symptoms including pain, fatigue, distress, and overall well-being (0-70; 0 better outcome; 70 worst outcome)
Measured: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
Change in health related quality of life
Generic Quality of life (EQ-5D-5L)
Measured: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
Change in individualized health related quality of life
Patient Generated Index
Measured: Assessments will be carried out prior to radiotherapy, pre-operatively, and at 2, 6 and 12 weeks post-operatively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2020
- Study start15 Sep 2020 (estimated)
- Primary completion15 Feb 2021 (estimated)
- Study completion15 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nancy Mayo, PhD, Principal investigator, Research Institute - MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04518488
- Sponsor's protocol ID
- SARC-Prehab (2021-6796)
- Status last verified
- Sep 2020
- First submitted
- 29 Jul 2020
- Last updated
- 21 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Starting Recovery Pre-operatively: Feasibility of Implementing Individualized Prehabilitation for People Scheduled for Lower Limb Soft-tissue Sarcoma Surgery
- ClinicalTrials.gov ID
- NCT04518488
- Acronym / sponsor ID
- SARC-Prehab (2021-6796)
- Conditions
- Soft Tissue Sarcoma
- Keywords
- prehabilitation, walking capacity, gait, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- 15 Sep 2020 (estimated)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 15 Sep 2021 (estimated)
- First posted
- 19 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prehabilitation group | Active comparator | Other: ExercisesThe 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. |
| Informational support group (control group) | Other | 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. 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Deep lower extremity Soft-tissue Sarcoma (buttock to foot)
- Histologically or cytologically-proven Soft-tissue Sarcoma (excluding superficial location) of the lower extremity.
Key exclusion criteria (2 listed)
- Patients with metastatic disease (distant or nodal)
- both and upper and lower extremity involvement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExercisesPersonalized and individualized exercises for lower limb soft-tissue sarcoma of each participant in this group. | Other | Prehabilitation 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. | Other | Informational support group (control group) |
Primary outcome
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)
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
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
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
3 secondary outcomes
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy Mayo, PhD principal investigator
Research Institute - MUHC
Questions about this trial
What is this clinical trial studying?
A study testing Exercises in people with Soft Tissue Sarcoma, run by McGill University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed Abou-Sharkh, MSc (5149341934 ext. 36922, ahmed.abou-sharkh@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.