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| ID | Type | Description | Link |
|---|---|---|---|
| 18-0226 | Other Identifier | Toronto Academic Health Sciences Network |
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| Name | Class |
|---|---|
| MOUNT SINAI HOSPITAL | OTHER |
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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).
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multimodal Prehabilitation | Experimental | Facility and home-based multimodal prehabilitation (aerobic exercise training, resistance exercise training, nutrition support, stress management and mindfulness training) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multimodal prehabilitation | Behavioral | Multimodal Prehabilitation
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Initiation through end of study recruitment at 12 months |
| 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 | Initiation through end of pre-operative testing |
| 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 | Initiation through end of study intervention period |
| Measure | Description | Time Frame |
|---|---|---|
| Patient identification rate (feasibility target: >=50% of OEP) | Defined as the average number of OEP identified each month | Initiation through end of study recruitmentat 12 months |
| Baseline assessment rate (feasibility target: >=90% of consenting participants) |
| Measure | Description | Time Frame |
|---|---|---|
| Global health score | Primary exploratory outcome: European Organization for the Research and Treatment of Cancer (EORTC) QLC-C30 | Baseline (T0), preoperative (T1), 1 month postoperative (T2) |
| Postoperative complications |
Inclusion Criteria:
Exclusion Criteria:
Planned resection of bony pelvis or major lower extremity neurovascular structures
Significant comorbidity including any of the following:
High-risk or presence of pathological fracture
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| Name | Affiliation | Role |
|---|---|---|
| Daniel R Santa Mina, PhD | University of Toronto; University Health Network | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Toronto | Ontario | M5G2C4 | Canada |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D012516 | Osteosarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018213 | Neoplasms, Bone Tissue |
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|
Defined as the percent of consenting patients who successfully complete baseline assessments based on the total number of consenting patients |
| Initiation through end of study recruitment at 12 months |
| Intervention window (feasibility target: >=21 days) | Defined as the average elapsed time (in days) between diagnosis and extremity sarcoma surgery | Initiation through end of study intervention period |
| 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 | Initiation through end of pre-operative testing |
| Testing performance (feasibility target: >=95% completion of tests) | Defined as percent completion physical testing at baseline and follow-up | Initiation through end of pre-operative testing |
| Testing modality adaptations (descriptive) | Defined as the percent of all tests which are adapted for functional or safety reasons | Initiation through end of pre-operative testing |
| Training modality adaptations (descriptive) | Defined as the percent of all exercise sessions which are adapted for functional or safety reasons | Initiation through end of study intervention period |
| 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 | Initiation through end of study intervention period |
| Treatment interruption (feasibility target: <=15% of participants) | Defined as the percent of patients who miss ≥3 consecutive sessions within the intervention period | Initiation through end of study intervention period |
| 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. | Initiation through end of study intervention period |
| Early session termination (feasibility target: <=25% of participants) | Defined as the percent of exercise sessions requiring unplanned early termination | Initiation through end of study intervention period |
| 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) | Initiation through end of study intervention period |
| Physical prehabilitation compliance (feasibility target: >=70% of prescribed) | Defined as the percent of exercise sessions completed based on the total number of sessions prescribed | Initiation through end of study intervention period |
| Mindfulness prehabilitation compliance (feasibility target: >=70% of prescribed) | Defined as the percent of psychological sessions completed based on the total number of sessions prescribed | Initiation through end of study intervention period |
| Attrition (feasibility target: <=20% loss to follow-up) | Defined as the percent loss to follow-up (not completing follow-up assessments), individually and overall | Study initiation through end of 1 month postoperative (T2) |
Postoperative complication severity and frequency defined according to the Common Terminology Criteria for Adverse Events.
| 1 month postoperative (T2) |
| Length of stay | Average postoperative hospitalization period | 1 month postoperative (T2) |
| Functional capacity | Total distance traveled during six-minute walk test | Baseline (T0), preoperative (T1) |
| Physical activity behavior (subjective) | Godin Leisure-time Exercise Questionnaire | Baseline (T0), preoperative (T1), 1 month postoperative (T2) |
| Health-related quality of life | EQ-5D; All 5 items are rated on a 1 to 3 scale with higher numbers reflecting worse outcomes. | Baseline (T0), preoperative (T1), 1 month postoperative (T2) |
| Symptom burden | Edmonton Symptom Assessment Scale (ESAS); All 10 items are rated on a 0 to 10 scale with higher numbers reflecting worse outcomes. | Baseline (T0), preoperative (T1), 1 month postoperative (T2) |
| Anxiety and depression | Hospital Anxiety and Depression Scale (HADS); All 14 items are rated on a 0 to 3 scale with higher numbers reflecting worse outcomes. | Baseline (T0), preoperative (T1), 1 month postoperative (T2) |
| Fatigue | Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F); All 13 items are rated on a 0 to 4 scale with higher numbers reflecting worse outcomes. | Baseline (T0), preoperative (T1), 1 month postoperative (T2) |
| Impact on work | Work Limitations Questionnaire | Baseline (T0), preoperative (T1), 1 month postoperative (T2) |
| Social support | Medical Outcomes Study Social Support Scale (SF-20); All item scores transformed into 0 to 100 scales with higher scores reflecting better outcomes. | Baseline (T0), preoperative (T1), 1 month postoperative (T2) |
| Relationships | Experiences in Close Relationships scale (ECR); All 36 items rated on a 1 to 7 scale with higher scores reflecting worse outcomes. | Baseline (T0), preoperative (T1), 1 month postoperative (T2) |
| Extremity function | Toronto Extremity Salvage Score (upper or lower) | Baseline (T0), preoperative (T1), 1 month postoperative (T2) |
| Disease burden | Musculoskeletal Tumor Society score | Baseline (T0), preoperative (T1), 1 month postoperative (T2) |
| D009372 | Neoplasms, Connective Tissue |