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Sarcoma,Soft TissuePICaSO-ESNCT04248959

Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas

A study testing Multimodal prehabilitation in people with Sarcoma,Soft Tissue and Osteosarcoma, run by University Health Network, Toronto at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to evaluate the feasibility of a multimodal prehabilitation intervention intended to optimize postoperative recovery in adolescents and young adults (AYAs) diagnosed with soft tissue and bone-based sarcomas of the upper and lower extremities (extremity sarcomas; ES). Read more about this study

Who is it for?
Ages 18 to 39 years
Conditions the study is for
Sarcoma,Soft Tissue, Osteosarcoma
What is being tested?
Multimodal prehabilitation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
1 siteCanada
Study dates
2 Feb 2022to 26 Apr 2023
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 18 to 39 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • ≥18 years and <40 years of age at diagnosis
  • Fluent in English
  • Able to comply with study and follow-up procedures contained within the consent form
  • Pathologically or radiologically confirmed diagnosis of a soft-tissue or osteosarcoma of the upper or lower extremities
  • Soft-tissue or osteosarcoma must be considered operable
  • Patients of all weight bearing states will be eligible
Show all 10Show fewer
  • Expected LOS ≥ 5 days as calculated by the validated American College of Surgeons Surgical Risk Calculator
  • >14 days between time of randomization and time of expected surgery
  • Patient written, informed consent obtained according to ICH GCP guidelines and local regulations
  • Medical clearance to participate in the study from either the primary treating surgeon (JW, PF) or oncologist (AG)

Who cannot join

  • Planned resection of bony pelvis or major lower extremity neurovascular structures
  • Significant comorbidity including any of the following:
  • Canadian Cardiovascular Society class III/IV coronary disease
  • New York Heart Association class III/IV congestive heart failure
  • Neurologic or musculoskeletal disorder prohibiting exercise
  • Major neuropsychiatric disorder
  • High-risk or presence of pathological fracture

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University Health Network

    Toronto, Ontario, M5G2C4

Other trials in Canada

About this study

Official title: Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas (PICaSO-ES): A Proof-of-Concept Trial

The purpose of this study was to evaluate the feasibility of a multimodal prehabilitation intervention intended to optimize postoperative recovery in adolescents and young adults (AYAs) diagnosed with soft tissue and bone-based sarcomas of the upper and lower extremities (extremity sarcomas; ES).

Read the detailed description

Objectives:

This objective of this study was to investigate the feasibility of multimodal prehabilitation for adolescents and young adults (AYAs) diagnosed with soft tissue and bone-based sarcomas of the upper and lower extremities (extremity sarcomas; ES) and explore its effects on measurements of health-related quality of life, physical function, length of hospital stays, and post-operative complications. Specific aims of the study included:

  • To determine the feasibility of conducting a larger phase II investigation of HIIT-based multimodal prehabilitation according to three primary criteria, including (i) recruiting >=50% of otherwise eligible patients (OEP; i.e., patients meeting all eligibility criteria), (ii) no patient experiences a testing-related or an intervention-related serious adverse event (SAE), and (iii) patients achieve an exercise intervention adherence rate of >=70%.
  • To further determine the feasibility of conducting a larger phase II investigation of HIIT-based multimodal prehabilitation according to the secondary feasibility criteria.
  • To explore the preliminary effects of prehabilitation on measures of short-term perioperative outcomes including health-related quality of life, physical function, length of hospital stays, and post-operative complications.

Methods:

A single-arm, proof-of-concept trial design was informed by the ORBIT model of behavioural treatment development. Mixed methods were employed to obtain relevant context for investigating the feasibility of multimodal prehabilitation in newly diagnosed AYAs with ES within the circumstances of the COVID-19 pandemic.

Participants underwent virtual multimodal prehabilitation before undergoing major extremity sarcoma surgery. This program encompassed personalized exercise, nutrition, and stress management support delivered by a registered kinesiologist, registered dietitian, and clinical psychologist, respectively. The interventions were designed to enhance physical and psychological resilience to stress, with the objective of improving recovery outcomes and mitigating the risk of adverse events.

Feasibility (e.g., recruitment, safety, tolerability), physical function, and patient-reported outcomes were measured at baseline (T0), immediately preoperatively (T1), and one month postoperatively (T2).

Feasibility data and field notes were collected by the research coordinators (during recruitment and postoperative follow-up) and by the study lead / research assistants during the intervention period. A postoperative interview explored experiences with prehabilitation into explore the feasibility and practical considerations of virtual prehabilitation for adolescents and young adults with extremity sarcomas.

Being tested
Multimodal prehabilitation
Keywords
Preoperative Care, Exercise Therapy, Prehabilitation, Extremity Sarcoma, Adolescents and Young Adults
Medical subject headings
Sarcoma, Osteosarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multimodal prehabilitationBehavioural

    Multimodal Prehabilitation

    • Aerobic exercise
    • Home-based, high-intensity interval training (HIIT), 2 days/week
    • Home-based, moderate-intensity continuous training (MICT), 2-3 days/week
    • Resistance exercise
    • Home-based, moderate-intensity resistance training, 2-3 d/wk, all major muscle groups (working around tumour-related deficits), 8-10 exercises, 12-15 repetitions, resistance bands and body weight based
    • Nutrition
    • Protein intake 1.2-1.5 g/kg body weight/day in compliance with European Society for Clinical Nutrition and Metabolism (ESPEN) guidelines
    • Stress management
    • Daily mindfulness practice, 20 min/session, guided by audio file created at Mount Sinai Hospital
Study groups in NCT04248959
Study groupRoleWhat they receive
Multimodal PrehabilitationExperimentalFacility and home-based multimodal prehabilitation (aerobic exercise training, resistance exercise training, nutrition support, stress management and mindfulness training)
Receives: Behavioral: Multimodal prehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient recruitment rate (feasibility target: >=50% of eligible participants)

    Defined as the percent of consenting patients based on the total number of otherwise eligible patients (OEP; patients meeting all study eligibility criteria) approached

    Measured: Initiation through end of study recruitment at 12 months

  2. Testing- and intervention-related serious adverse events (feasibility target: none)

    Defined as the number and frequency of testing- and intervention-related serious adverse events (SAEs) according to the Common Terminology Criteria for Adverse Events

    Measured: Initiation through end of pre-operative testing

  3. Patient exercise adherence (feasibility target: >=70% of prescribed)

    Defined as relative dose intensity as the percent of total dose of exercise performed relative to the total planned dose prescribed and quantified according to metabolic equivalents

    Measured: Initiation through end of study intervention period

Secondary outcomes (15)

  1. Patient identification rate (feasibility target: >=50% of OEP)

    Defined as the average number of OEP identified each month

    Measured: Initiation through end of study recruitmentat 12 months

  2. Baseline assessment rate (feasibility target: >=90% of consenting participants)

    Defined as the percent of consenting patients who successfully complete baseline assessments based on the total number of consenting patients

    Measured: Initiation through end of study recruitment at 12 months

  3. Intervention window (feasibility target: >=21 days)

    Defined as the average elapsed time (in days) between diagnosis and extremity sarcoma surgery

    Measured: Initiation through end of study intervention period

  4. Testing- and intervention-related non-serious adverse events (feasibility target: <20% of sessions)

    Defined as the number and frequency of testing- and intervention-related non-serious adverse events (nSAEs) according to the Common Terminology Criteria for Adverse Events

    Measured: Initiation through end of pre-operative testing

  5. Testing performance (feasibility target: >=95% completion of tests)

    Defined as percent completion physical testing at baseline and follow-up

    Measured: Initiation through end of pre-operative testing

  6. Testing modality adaptations (descriptive)

    Defined as the percent of all tests which are adapted for functional or safety reasons

    Measured: Initiation through end of pre-operative testing

  7. Training modality adaptations (descriptive)

    Defined as the percent of all exercise sessions which are adapted for functional or safety reasons

    Measured: Initiation through end of study intervention period

  8. Permanent treatment discontinuation (feasibility target: <=15% of participants)

    Defined as the percent of patients who discontinue intervention participation prior to the planned end of the intervention period

    Measured: Initiation through end of study intervention period

  9. Treatment interruption (feasibility target: <=15% of participants)

    Defined as the percent of patients who miss ≥3 consecutive sessions within the intervention period

    Measured: Initiation through end of study intervention period

  10. Dose modification (feasibility target: <=25% of participants)

    Defined as the percent of exercise sessions requiring a dose reduction during training (i.e., intensity or duration) relative to the total number of sessions completed. Total number of exercise sessions with a reduction in intensity or a reduction in duration will be combined into the numerator when calculating the percentage of affected sessions.

    Measured: Initiation through end of study intervention period

  11. Early session termination (feasibility target: <=25% of participants)

    Defined as the percent of exercise sessions requiring unplanned early termination

    Measured: Initiation through end of study intervention period

  12. Pretreatment intensity modification (feasibility target: <=25% of participants)

    Defined as the percent of sessions which required pre-exercise modification of the target exercise intensity due to a pre-exercise screening indication (e.g., fatigue, pain)

    Measured: Initiation through end of study intervention period

  13. Physical prehabilitation compliance (feasibility target: >=70% of prescribed)

    Defined as the percent of exercise sessions completed based on the total number of sessions prescribed

    Measured: Initiation through end of study intervention period

  14. Mindfulness prehabilitation compliance (feasibility target: >=70% of prescribed)

    Defined as the percent of psychological sessions completed based on the total number of sessions prescribed

    Measured: Initiation through end of study intervention period

  15. Attrition (feasibility target: <=20% loss to follow-up)

    Defined as the percent loss to follow-up (not completing follow-up assessments), individually and overall

    Measured: Study initiation through end of 1 month postoperative (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jan 2020
  2. Study start2 Feb 2022
  3. Primary completion26 Apr 2023
  4. Study completion26 Apr 2023

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04248959
Sponsor's protocol ID
18-5901
Other IDs
18-0226
Acronym
PICaSO-ES
Status last verified
Dec 2023
First submitted
22 Jan 2020
Last updated
27 Dec 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Multimodal prehabilitation in people with Sarcoma,Soft Tissue and Osteosarcoma, run by University Health Network, Toronto at 1 site in Canada.

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 10 inclusion and 7 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: finished, as of the sponsor's last update on 27 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient recruitment rate (feasibility target: >=50% of eligible participants) (time frame: Initiation through end of study recruitment at 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04248959.

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 27 Dec 2023.

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