Bridging Adolescent and Young Adult Sarcoma Survivors With Personalized Oncology Exercise Service (AYA-ONE): A Pilot Intervention (AYA-ONE)
2026年8月24日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
40
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Chao Cao, MD
- 电话号码：617-632-4237
- 邮箱：chao_cao@dfci.harvard.edu
学习地点
-
-
Massachusetts
-
Boston、Massachusetts、美国、02115
- 招聘中
- Boston Children's Hospital
-
首席研究员：
- Chao Cao, MD
-
接触：
- Chao Cao, MD
- 电话号码：617-632-4237
- 邮箱：chao_cao@dfci.harvard.edu
-
Boston、Massachusetts、美国、02115
- 招聘中
- Brigham and Women's Hospital
-
首席研究员：
- Chao Cao, MD
-
接触：
- Chao Cao, MD
- 电话号码：617-632-4237
- 邮箱：chao_cao@dfci.harvard.edu
-
Boston、Massachusetts、美国、02115
- 招聘中
- Dana-Farber Cancer Institute
-
首席研究员：
- Chao Cao, MD
-
接触：
- Chao Cao, MD
- 电话号码：617-632-4237
- 邮箱：chao_cao@dfci.harvard.edu
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Exercise Triage and Personalized Exercise Program
All participants receive this intervention.
|
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Triage Tool Completion Rate
大体时间：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
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Height from Baseline
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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).
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Chao Cao, MD、Dana-Farber Cancer Institute
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年8月1日
初级完成 (估计的)
2027年8月1日
研究完成 (估计的)
2027年12月31日
研究注册日期
首次提交
2026年6月16日
首先提交符合 QC 标准的
2026年6月16日
首次发布 (实际的)
2026年6月23日
研究记录更新
最后更新发布 (实际的)
2026年8月26日
上次提交的符合 QC 标准的更新
2026年8月24日
最后验证
2026年6月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
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 共享时间框架
Data can be shared no earlier than 1 year following the date of publication
IPD 共享访问标准
Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.