An interventional study of Exercise Triage and Personalized Exercise Program in Sarcoma, Bone Sarcoma and Soft Tissue Sarcoma (STS), sponsored by Dana-Farber Cancer Institute. Recruiting at 3 sites in United States. Open to participants aged 15 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Dana-Farber Cancer Institute · Not applicable, Interventional, and Supportive care
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.
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.
1,607 studies on the registry are indexed under Sarcoma; 366 are open to participants now.
This study's planned enrollment of 40 is close to the median of 40 across 1,255 interventional studies indexed under Sarcoma.
Browse Sarcoma studies →Dana-Farber Cancer Institute is the lead sponsor of 834 studies on the registry; 122 are open to participants now.
Of its 114 completed or terminated interventional studies of FDA-regulated products, 78 (68%) have results posted.
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Exclusion Criteria:
All participants receive this intervention.
Behavioral: 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.
Triage Tool Completion Rate
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.
Time frame: 2 weeks
Referral Completion Rate
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.
Time frame: Within 2 months of EXCEEDS completion
Change in Height from Baseline
Height is obtained from clinical visits or measured by study staff.
Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).
Change in Body Weight from Baseline
Weight is obtained from clinical visits or measured by study staff.
Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).
Change in Total Leisure Activity Score from Baseline
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.
Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).
Change in Peak Oxygen Consumption (VO₂ Peak) from Baseline
VO₂ peak is estimated using the University of Northern Colorado Cancer Rehabilitation Institute (UNCCRI) Treadmill Protocol based on the highest completed stage.
Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).
Change in 6-Minute Walk Distance from Baseline
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.
Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).
Change in Lower Quarter Y-Balance Composite Score from Baseline
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.
Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).
Change in Upper Extremity Strength from Baseline
Upper-extremity strength assessed using the Grip Strength Test. Grip strength is measured using a hand dynamometer.
Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).
Change in Number of Repetitions Completed from Baseline
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.
Time frame: 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
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.
Time frame: Assessed at pre-program (baseline) and post-program (12 weeks).
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data can be shared no earlier than 1 year following the date of publication
Access criteria: Contact the Belfer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu.
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