SarcomaAYA-ONENCT07662239
Bridging Adolescent and Young Adult Sarcoma Survivors With Personalized Oncology Exercise Service (AYA-ONE): A Pilot Intervention
A study testing Exercise Triage and Personalized Exercise Program in people with Sarcoma and Bone Sarcoma, run by Dana-Farber Cancer Institute at 3 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 15 to 39 years
- Conditions the study is for
- Sarcoma, Bone Sarcoma, Soft Tissue Sarcoma (STS)
- What is being tested?
- Exercise Triage and Personalized Exercise Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Aug 2026to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 39 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Chao Cao, MD, 617-632-4237, chao_cao@dfci.harvard.edu
Chao Cao, MD
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Chao Cao, MD, 617-632-4237, chao_cao@dfci.harvard.edu
Chao Cao, MD
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
Chao Cao, MD, 617-632-4237, chao_cao@dfci.harvard.edu
Chao Cao, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Sarcoma, Bone Sarcoma, Soft Tissue Sarcoma (STS)
- Being tested
- Exercise Triage and Personalized Exercise Program
- Keywords
- sarcoma, bone sarcoma, soft tissue sarcoma
- Medical subject headings
- Sarcoma, Bone Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise Triage and Personalized Exercise ProgramBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Triage and Personalized Exercise Program | Experimental | All participants receive this intervention. Receives: Behavioral: Exercise Triage and Personalized Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 2 months of EXCEEDS completion
Secondary outcomes (9)
Change in Height from Baseline
Height is obtained from clinical visits or measured by study staff.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Assessed at pre-program (baseline) and post-program (12 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2026
- Study start1 Aug 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcomaStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Cao, Dana-Farber Cancer Institute
- Investigators
- Chao Cao, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07662239
- Sponsor's protocol ID
- 26-106
- Acronym
- AYA-ONE
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.