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Bridging Adolescent and Young Adult Sarcoma Survivors With Personalized Oncology Exercise Service (AYA-ONE): A Pilot Intervention (AYA-ONE)

24 augustus 2026 bijgewerkt door: Chao Cao, 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Massachusetts
      • Boston, Massachusetts, Verenigde Staten, 02115
        • Werving
        • Boston Children's Hospital
        • Hoofdonderzoeker:
          • Chao Cao, MD
        • Contact:
      • Boston, Massachusetts, Verenigde Staten, 02115
        • Werving
        • Brigham and Women's Hospital
        • Hoofdonderzoeker:
          • Chao Cao, MD
        • Contact:
      • Boston, Massachusetts, Verenigde Staten, 02115
        • Werving
        • Dana-Farber Cancer Institute
        • Hoofdonderzoeker:
          • Chao Cao, MD
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Kind
  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Ondersteunende zorg
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Exercise Triage and Personalized Exercise Program
All participants receive this intervention.
Gedragsmatig: Exercise Triage and Personalized Exercise Program
  • Part 1: Completion of the EXCEEDS triage tool to assess physical function and determine appropriate referral to rehabilitation or exercise services.
  • Part 2: Eligible participants receive a 12-week personalized exercise program, which may be supervised or unsupervised, and includes a Garmin activity monitor, resistance bands, and a stepper machine.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Triage Tool Completion Rate
Tijdsspanne: 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.
2 weeks
Referral Completion Rate
Tijdsspanne: 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.
Within 2 months of EXCEEDS completion

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Height from Baseline
Tijdsspanne: Assessed at pre-program (baseline) and post-program (12 weeks).
Height is obtained from clinical visits or measured by study staff.
Assessed at pre-program (baseline) and post-program (12 weeks).
Change in Body Weight from Baseline
Tijdsspanne: 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).
Change in Total Leisure Activity Score from Baseline
Tijdsspanne: 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).
Change in Peak Oxygen Consumption (VO₂ Peak) from Baseline
Tijdsspanne: 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.
Assessed at pre-program (baseline) and post-program (12 weeks).
Change in 6-Minute Walk Distance from Baseline
Tijdsspanne: 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).
Change in Lower Quarter Y-Balance Composite Score from Baseline
Tijdsspanne: 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.
Assessed at pre-program (baseline) and post-program (12 weeks).
Change in Upper Extremity Strength from Baseline
Tijdsspanne: 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.
Assessed at pre-program (baseline) and post-program (12 weeks).
Change in Number of Repetitions Completed from Baseline
Tijdsspanne: 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.
Assessed at pre-program (baseline) and post-program (12 weeks).
Change in PROMIS-29 (Patient-Reported Outcomes Measurement Information System 29-Item Profile) Score from Baseline
Tijdsspanne: Assessed at pre-program (baseline) and post-program (12 weeks).
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.
Assessed at pre-program (baseline) and post-program (12 weeks).

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Dana-Farber Cancer Institute

Onderzoekers

  • Hoofdonderzoeker: Chao Cao, MD, Dana-Farber Cancer Institute

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 augustus 2026

Primaire voltooiing (Geschat)

1 augustus 2027

Studie voltooiing (Geschat)

31 december 2027

Studieregistratiedata

Eerst ingediend

16 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

16 juni 2026

Eerst geplaatst (Werkelijk)

23 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

26 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

24 augustus 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 26-106

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

Data can be shared no earlier than 1 year following the date of publication

IPD-toegangscriteria voor delen

Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

product vervaardigd in en geëxporteerd uit de V.S.

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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