CompletedNot Applicable

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

Canada7 participantsStarted 2022-02-02

Plain-language 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).

Who can participate

Age range

18 Years – 39 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * ≥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 * 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) Exclusion Criteria: * 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Initiation through end of study recruitment at 12 months

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

Timeframe: Initiation through end of pre-operative testing

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

Timeframe: Initiation through end of study intervention period

Trial details

NCT IDNCT04248959

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-26

View on ClinicalTrials.gov More Sarcoma,Soft Tissue trials