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

24 de agosto de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

40

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02115
        • Recrutamento
        • Boston Children's Hospital
        • Investigador principal:
          • Chao Cao, MD
        • Contato:
      • Boston, Massachusetts, Estados Unidos, 02115
        • Recrutamento
        • Brigham and Women's Hospital
        • Investigador principal:
          • Chao Cao, MD
        • Contato:
      • Boston, Massachusetts, Estados Unidos, 02115
        • Recrutamento
        • Dana-Farber Cancer Institute
        • Investigador principal:
          • Chao Cao, MD
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho
  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: N / D
  • Modelo Intervencional: Atribuição de grupo único
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Exercise Triage and Personalized Exercise Program
All participants receive this intervention.
Comportamental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Triage Tool Completion Rate
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Height from Baseline
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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).

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Dana-Farber Cancer Institute

Investigadores

  • Investigador principal: Chao Cao, MD, Dana-Farber Cancer Institute

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de agosto de 2026

Conclusão Primária (Estimado)

1 de agosto de 2027

Conclusão do estudo (Estimado)

31 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

16 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

16 de junho de 2026

Primeira postagem (Real)

23 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de agosto de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 26-106

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de IPD

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

Critérios de acesso de compartilhamento IPD

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

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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