Bridging Adolescent and Young Adult Sarcoma Survivors With Personalized Oncology Exercise Service (AYA-ONE): A Pilot Intervention (AYA-ONE)
16. června 2026 aktualizováno: Vinayak Venkataraman, Dana-Farber Cancer Institute
This study will evaluate strategies to improve physical function and promote exercise and physical activity in adolescents and young adults (AYAs) with sarcoma.
The study will assess the feasibility of a standardized triage system for referring AYAs with sarcoma to appropriate exercise and rehabilitation services, and will also examine changes in physical function and health-related quality of life before and after a 12-week personalized exercise program.
Přehled studie
Postavení
Zatím nenabíráme
Intervence / Léčba
Detailní popis
This is a single-arm pilot study evaluating the feasibility of using a modified Exercise in Cancer Evaluation and Decision Support (EXCEEDS) algorithm to triage and refer adolescents and young adults (AYAs) with sarcoma to rehabilitation and exercise services at Dana-Farber Cancer Institute (DFCI). The AYA-ONE study has two parts: Part 1 includes triage and referral using the EXCEEDS tool, and Part 2 includes a 12-week personalized exercise program for eligible participants. The EXCEEDS tool is designed to help match participants to rehabilitation and exercise services based on their needs. Participants in Part 2 will receive a Garmin activity monitor, resistance bands, a stepper machine, and a 12-week exercise program, which may be supervised or unsupervised.
The research study procedures include: screening for eligibility, triage and referral using the EXCEEDS tool, rehabilitation and exercise service referral, and, for eligible participants, a 12-week personalized exercise program.
It is expected that about 40 people will take part in Part 1 of this study. About 20 people are expected to participate in the full study, including both Part 1 and Part 2.
Participation in this research study is expected to last about 6 months.
Typ studie
Intervenční
Zápis (Odhadovaný)
40
Fáze
- Nelze použít
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Vinayak Venkataraman, MD
- Telefonní číslo: 617-632-5204
- E-mail: vinayak_venkataraman@dfci.harvard.edu
Studijní místa
-
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Massachusetts
-
Boston, Massachusetts, Spojené státy, 02115
- Dana-Farber Cancer Institute
-
Kontakt:
- Vinayak Venkataraman, MD
- Telefonní číslo: 617-632-5204
- E-mail: vinayak_venkataraman@dfci.harvard.edu
-
Vrchní vyšetřovatel:
- Vinayak Venkataraman, MD
-
Boston, Massachusetts, Spojené státy, 02115
- Brigham and Women's Hospital
-
Kontakt:
- Vinayak Venkataraman, MD
- Telefonní číslo: 617-632-5204
- E-mail: vinayak_venkataraman@dfci.harvard.edu
-
Vrchní vyšetřovatel:
- Vinayak Venkataraman, MD
-
Boston, Massachusetts, Spojené státy, 02115
- Boston Children's Hospital
-
Kontakt:
- Vinayak Venkataraman, MD
- Telefonní číslo: 617-632-5204
- E-mail: vinayak_venkataraman@dfci.harvard.edu
-
Vrchní vyšetřovatel:
- Vinayak Venkataraman, MD
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
Inclusion Criteria:
- Diagnosed with a bone or soft tissue sarcoma
- Age 15-39 at time of diagnosis
- Age 15 and older at time of enrollment
- Age 15-17 at time of enrollment, with assent from participant and consent from parent/legal guardian
- Established patient of the DFCI Sarcoma Center or Jimmy Fund
- Able to read and understand English (to complete required questionnaires and participate in training/coaching)
- Individuals who are not yet adults (teenagers) if they assent and their parents/legal guardians' consent to participation.
Exclusion Criteria:
- Unstable cardiovascular disease in the last 6 months
- Psychiatric disorders or conditions that would preclude participation in the study intervention (e.g. untreated major depression or psychosis, untreated substance use disorder, severe personality disorder)
- Pregnant
- Currently participating in physical or occupational therapy
- Presence of medical conditions or medications that would prohibit participation in an exercise program
- Meeting exercise guidelines of 150 minutes of moderate intensity/75 minutes of vigorous intensity physical activity per week plus consistent strength training (at least once per week) over the past 3 months. Assessed via Godin Leisure Time Questionnaire by study staff.
- Adults unable to consent
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: N/A
- Intervenční model: Přiřazení jedné skupiny
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Exercise Triage and Personalized Exercise Program
All participants receive this intervention.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Triage Tool Completion Rate
Časové okno: 2 weeks
|
Triage tool completion rate is defined as the proportion of consented participants who fully completed the Exercise in Cancer Evaluation and Decision Support (EXCEEDS) tool.
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2 weeks
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Referral Completion Rate
Časové okno: Within 2 months of EXCEEDS completion
|
Referral completion rate is defined as the rate of participants who completed the EXCEEDS tool and subsequently completed an initial visit with an occupational therapist (OT), physical therapist (PT), trainer, or health coach.
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Within 2 months of EXCEEDS completion
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Height from Baseline
Časové okno: Assessed at pre-program (baseline) and post-program (12 weeks).
|
Height is obtained from clinical visits or measured by study staff.
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Assessed at pre-program (baseline) and post-program (12 weeks).
|
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Change in Body Weight from Baseline
Časové okno: Assessed at pre-program (baseline) and post-program (12 weeks).
|
Weight is obtained from clinical visits or measured by study staff.
|
Assessed at pre-program (baseline) and post-program (12 weeks).
|
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Change in Total Leisure Activity Score from Baseline
Časové okno: Assessed at pre-program (baseline) and post-program (12 weeks).
|
Total Leisure Activity Score is calculated from the reported weekly frequency of strenuous, moderate, and light leisure-time physical activity sessions lasting at least 15 minutes, based on Godlin Leisure-Time Questionnaire.
The total score is calculated as (9 × strenuous sessions/week) + (5 × moderate sessions/week) + (3 × light sessions/week).
Higher scores indicate greater leisure-time physical activity.
|
Assessed at pre-program (baseline) and post-program (12 weeks).
|
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Change in Peak Oxygen Consumption (VO₂ Peak) from Baseline
Časové okno: Assessed at pre-program (baseline) and post-program (12 weeks).
|
VO₂ peak is estimated using the University of Northern Colorado Cancer Rehabilitation Institute (UNCCRI) Treadmill Protocol based on the highest completed stage.
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Assessed at pre-program (baseline) and post-program (12 weeks).
|
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Change in 6-Minute Walk Distance from Baseline
Časové okno: Assessed at pre-program (baseline) and post-program (12 weeks).
|
The test measures the total distance walked in meters during a 6-minute period and is performed for participants unable to complete the UNCCRI Treadmill Protocol.
|
Assessed at pre-program (baseline) and post-program (12 weeks).
|
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Change in Lower Quarter Y-Balance Composite Score from Baseline
Časové okno: Assessed at pre-program (baseline) and post-program (12 weeks).
|
Lower Quarter Y-Balance Composite Score is calculated as the sum of the anterior, posteromedial, and posterolateral reach distances divided by three times the limb length and multiplied by 100.
The score is expressed as a percentage of limb length, with higher scores indicating better dynamic balance and lower-extremity functional performance.
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Assessed at pre-program (baseline) and post-program (12 weeks).
|
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Change in Upper Extremity Strength from Baseline
Časové okno: Assessed at pre-program (baseline) and post-program (12 weeks).
|
Upper-extremity strength assessed using the Grip Strength Test.
Grip strength is measured using a hand dynamometer.
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Assessed at pre-program (baseline) and post-program (12 weeks).
|
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Change in Number of Repetitions Completed from Baseline
Časové okno: Assessed at pre-program (baseline) and post-program (12 weeks).
|
The number of repetitions completed during the 30-Second Sit-to-Stand Test is defined as the total number of completed sit-to-stand repetitions within 30 seconds.
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Assessed at pre-program (baseline) and post-program (12 weeks).
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Change in PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-Item Profile) Score from Baseline
Časové okno: Assessed at pre-program (baseline) and post-program (12 weeks).
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PROMIS-29 includes the domains of physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, pain interference, and pain intensity.
Physical function, anxiety, depression, fatigue, sleep disturbance, ability to participate in social roles and activities, and pain interference scores are each derived from 4 questions scored on a 5-point scale, with total scores ranging from 4 to 20 for each domain.
Higher scores indicate better functioning for physical function and ability to participate in social roles and activities, and worse symptoms for anxiety, depression, fatigue, sleep disturbance, and pain interference.
Pain intensity is assessed using a single question scored from 0 to 10, with higher scores indicating greater pain intensity.
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Assessed at pre-program (baseline) and post-program (12 weeks).
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Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Vinayak Venkataraman, MD, Dana-Farber Cancer Institute
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. srpna 2026
Primární dokončení (Odhadovaný)
28. srpna 2026
Dokončení studie (Odhadovaný)
1. února 2027
Termíny zápisu do studia
První předloženo
16. června 2026
První předloženo, které splnilo kritéria kontroly kvality
16. června 2026
První zveřejněno (Aktuální)
23. června 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
23. června 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
16. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 26-106
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
The Harvard Cancer Consortium encourages and supports the responsible and ethical sharing of data from clinical trials.
De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement.
Requests may be directed to: [contact information for Sponsor Investigator or designee].
The protocol and statistical analysis plan will be made available on Clinicaltrials.gov
only as required by federal regulation or as a condition of awards and agreements supporting the research.
Časový rámec sdílení IPD
Data can be shared no earlier than 1 year following the date of publication
Kritéria přístupu pro sdílení IPD
Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ne
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .