Clinical trial NCT04248959: Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas
Official title: Prehabilitation to Improve Cancer Surgery Outcomes in AYA Patients With Extremity Sarcomas (PICaSO-ES): A Proof-of-Concept Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoma,Soft Tissue
Osteosarcoma
Keywords: Preoperative Care
Exercise Therapy
Prehabilitation
Extremity Sarcoma
Adolescents and Young Adults
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: MOUNT SINAI HOSPITAL
First posted: 2020-01-30
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient recruitment rate (feasibility target: >=50% of eligible participants)
timeFrame: Initiation through end of study recruitment at 12 months
measure: Testing- and intervention-related serious adverse events (feasibility target: none)
timeFrame: Initiation through end of pre-operative testing
measure: Patient exercise adherence (feasibility target: >=70% of prescribed)
timeFrame: Initiation through end of study intervention period
Secondary outcomes:
measure: Patient identification rate (feasibility target: >=50% of OEP)
timeFrame: Initiation through end of study recruitmentat 12 months
measure: Baseline assessment rate (feasibility target: >=90% of consenting participants)
timeFrame: Initiation through end of study recruitment at 12 months
measure: Intervention window (feasibility target: >=21 days)
timeFrame: Initiation through end of study intervention period
measure: Testing- and intervention-related non-serious adverse events (feasibility target: <20% of sessions)
timeFrame: Initiation through end of pre-operative testing
measure: Testing performance (feasibility target: >=95% completion of tests)
timeFrame: Initiation through end of pre-operative testing
measure: Testing modality adaptations (descriptive)
timeFrame: Initiation through end of pre-operative testing
measure: Training modality adaptations (descriptive)
timeFrame: Initiation through end of study intervention period
measure: Permanent treatment discontinuation (feasibility target: <=15% of participants)
timeFrame: Initiation through end of study intervention period
measure: Treatment interruption (feasibility target: <=15% of participants)
timeFrame: Initiation through end of study intervention period
measure: Dose modification (feasibility target: <=25% of participants)
timeFrame: Initiation through end of study intervention period
measure: Early session termination (feasibility target: <=25% of participants)
timeFrame: Initiation through end of study intervention period
measure: Pretreatment intensity modification (feasibility target: <=25% of participants)
timeFrame: Initiation through end of study intervention period
measure: Physical prehabilitation compliance (feasibility target: >=70% of prescribed)
timeFrame: Initiation through end of study intervention period
measure: Mindfulness prehabilitation compliance (feasibility target: >=70% of prescribed)
timeFrame: Initiation through end of study intervention period
measure: Attrition (feasibility target: <=20% loss to follow-up)
timeFrame: Study initiation through end of 1 month postoperative (T2)
Other outcomes:
measure: Global health score
timeFrame: Baseline (T0), preoperative (T1), 1 month postoperative (T2)
measure: Postoperative complications
timeFrame: 1 month postoperative (T2)
measure: Length of stay
timeFrame: 1 month postoperative (T2)
measure: Functional capacity
timeFrame: Baseline (T0), preoperative (T1)
measure: Physical activity behavior (subjective)
timeFrame: Baseline (T0), preoperative (T1), 1 month postoperative (T2)
measure: Health-related quality of life
timeFrame: Baseline (T0), preoperative (T1), 1 month postoperative (T2)
measure: Symptom burden
timeFrame: Baseline (T0), preoperative (T1), 1 month postoperative (T2)
measure: Anxiety and depression
timeFrame: Baseline (T0), preoperative (T1), 1 month postoperative (T2)
measure: Fatigue
timeFrame: Baseline (T0), preoperative (T1), 1 month postoperative (T2)
measure: Impact on work
timeFrame: Baseline (T0), preoperative (T1), 1 month postoperative (T2)
measure: Social support
timeFrame: Baseline (T0), preoperative (T1), 1 month postoperative (T2)
measure: Relationships
timeFrame: Baseline (T0), preoperative (T1), 1 month postoperative (T2)
measure: Extremity function
timeFrame: Baseline (T0), preoperative (T1), 1 month postoperative (T2)
measure: Disease burden
timeFrame: Baseline (T0), preoperative (T1), 1 month postoperative (T2)
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University of Toronto; University Health Network
name: Daniel R Santa Mina, PhD
role: PRINCIPAL_INVESTIGATOR
References: