Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2025-12-25 @ 1:27 PM
Study NCT ID:
NCT04248959
Status:
COMPLETED
Last Update Posted:
2023-12-27
First Post:
2020-01-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas (PICaSO-ES): A Proof-of-Concept Trial
Status:
COMPLETED
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PICaSO-ES
Brief 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).
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 18-0226 | OTHER | Toronto Academic Health Sciences Network | View |