SarcomaNCT07516353
my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
A study testing my.naviGATE Digital Tool in people with Sarcoma and Osteosarcoma, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
This study aims to design and test a novel, personalized digital intervention-my.naviGATE-for adolescent and young adults (AYA) with cancer. my.naviGATE is a mobile app that provides personalized survivorship education, access to virtual peer navigation, and responsive participant-reported outcomes (PROs). Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Sarcoma, Osteosarcoma, Ewing Sarcoma
- What is being tested?
- my.naviGATE Digital Tool
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2026to 31 Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged 15-24 who are currently undergoing cancer treatment at one of the three participating sites: DFCI, CNH, or RPOCH.
- Patients must have initiated and be actively receiving cancer directed therapy for a newly diagnosed cancer.
- Patients must be actively receiving cancer directed therapy, between the time of diagnosis and end of therapy for the following diagnoses: 1) Sarcomas: including osteosarcoma, Ewing sarcoma, and rhabdomyosarcoma; 2) Acute Myeloid Leukemia (AML); 3) Acute Lymphoblastic Leukemia/Lymphoma (ALL); 4) Hodgkin and mature B-cell Lymphomas; and 5) Medulloblastoma.
- Patients whose treatment includes alkylators, anthracyclines, and/or radiation.
- This study is designed to keep AYAs aged 15-24 engaged in cancer survivorship care and therefore a subset of participants will be <18 years of age. The rationale for inclusion of children in this study is that AYA cancer survivors are particularly vulnerable to loss to follow-up and consequently lack of risk-based survivorship care, resulting in increased risk for preventable toxicity. Many existing interventions to improve engagement in survivorship screening and care are introduced after treatment completion and in long-term survivorship. Yet, for patients who are unaware of their late effect risks, and/or those who move frequently and are lost to follow-up, this may be too late. This study is designed to improve awareness of and engagement in risk-informed survivorship care for AYAs. This study presents no more than minimal risk to participants.
Who cannot join
- Patients who are unwilling to give informed consent or assent to participate will be excluded. For patients under 18, patients whose guardians do not give informed consent will be excluded.
- Patients with no chance of cure as identified by the AYA's physician, will be excluded given that issues of survivorship are not relevant and may be distressing to this population. Similarly, patients with relapsed or refractory disease will also be excluded.
- Patients who are non-English-speaking and -reading will be excluded as the digital tool is being developed initially in English.
- We will seek physician permission before offering enrollment to patients. If the provider team requests that the patient not be approached to participate, the patient will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Katie Greenzang, MD, 6176325992, katie_greenzang@dfci.harvard.edu
Katie Greenzang, MD
About this study
This study aims to design and test a novel, personalized digital intervention-my.naviGATE-for adolescent and young adults (AYA) with cancer. my.naviGATE is a mobile app that provides personalized survivorship education, access to virtual peer navigation, and responsive participant-reported outcomes (PROs).
Read the detailed description
This multi-center, pilot study aims to design and test a novel, personalized digital intervention-my.naviGATE-for adolescent and young adults (AYA) with cancer. My.naviGATE is a mobile app that provides personalized survivorship education, access to virtual peer navigation, and responsive participant-reported outcomes (PROs).
Participants in this research study will be randomized into 1 of 2 study groups: my.naviGATE Group versus Usual Care Group. Randomization means a participant is placed into a study group by chance.
The research study procedures include questionnaires or surveys, use of the mobile app for those randomized to the intervention, and qualitative interviews with study personnel for a subset of participants.
It is expected about 143 people will participate in this research study.
The Hyundai Hope On Wheels Foundation is supporting this research study by providing funding.
- Conditions
- Sarcoma, Osteosarcoma, Ewing Sarcoma, Rhabdomyosarcoma, Acute Myeloid Leukemia, Aml
- Being tested
- my.naviGATE Digital Tool
- Keywords
- Cancer Survivorship, Adolescent and Young Adult Cancer, Late Effects of Cancer Treatment, Hodgkin and mature B-cell Lymphomas, Acute Lymphoblastic Leukemia/Lymphoma, Sarcoma, Osteosarcoma, Ewing Sarcoma, Rhabdomyosarcoma, Acute Myeloid Leukemia, Aml, ALL, Medulloblastoma
- Medical subject headings
- Sarcoma, Osteosarcoma, Sarcoma, Ewing, Rhabdomyosarcoma, Leukemia, Myeloid, Acute, Medulloblastoma, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
my.naviGATE Digital ToolBehavioural
: A HIPAA-compliant digital health intervention in the form of a mobile application that provides personalized cancer survivorship education based on individual treatment regimens, virtual visits with trained peer navigators, and collection questionnaires/survey responses.
| Study group | Role | What they receive |
|---|---|---|
| my.naviGATE Group | Experimental | Participants will be randomized in a 1:1 ratio to this study group and will complete the following:
* Baseline survey
* 1 month survey
* 6 month survey
* Virtual interview (subset of participants) Receives: Behavioral: my.naviGATE Digital Tool |
| Usual Care Group | No intervention | Participants will be randomized in a 1:1 ratio to this study group and will receive standard oncology care and will complete the following: * Baseline survey * 1 month survey * 6 month survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Patient Activation Measure (PAM)-13 Score from Baseline to 6 Months Post-EOT
The Patient Activation Measure (PAM-13) is a validated, self-administered questionnaire assessing knowledge, skills, and confidence for self health-management. It has 13 items with a standardized score from 1-100 derived from 4-point Likert scale answer choices ranging from "Disagree Strongly" to "Agree Strongly;" a higher standardized score represents greater activation.
Measured: Assessed at baseline, 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
Application (App) Feasibility Rate (Intervention Group)
App feasibility rate is the proportion of participants in the intervention group ever using the my.naviGATE app. Usage metrics are collected through the app development platform.
Measured: Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
Application (App) Acceptability Rate (Intervention Group)
App acceptability will be assessed in the intervention group with an adapted acceptability electronic (E)-scale for web-based PROs in cancer care. Acceptability rate is the proportion of patients achieving acceptability on the 3-item scale, each using the 5-point Likert scale (1=lowest acceptability/not acceptable to 5 highest acceptability). The score ranges from 3-15 points and a score of 12 or higher indicates acceptability. (Tariman et al. Appl Nurs Res. 2011)
Measured: Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
Secondary outcomes (4)
Patient Assessment of Cancer Communication Experiences (PACE) Scale Score (Treatment Completed Set) at 6 Months Post-EOT
The PACE Scale (treatment completed set) is a 6-item questionnaire assessing communication and support experiences during and after cancer treatment. Questions are rated on a Likert-style scale ranging from "Never" to "Always" or "Poor" to "Excellent." Across a sample of patients with a variety of cancers, 70% rated post-cancer treatment communication as excellent.
Measured: Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
Preparedness for Survivorship Score at 6 Months Post-EOT
Preparedness for survivorship is measured on a 10-item scale with response items ranging from "strongly agree" (4) to "strongly disagree" (1) or "strongly satisfied" (5) to "not at all satisfied" (1); higher mean composite scores suggests increased perceived preparedness for survivorship.
Measured: Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
Self-Efficacy Score at 6 Months Post-EOT
Self-efficacy for late effect and survivorship care planning will be measured by two adapted 3-item self-efficacy scales. The mean of the Late Effects Self-Efficacy scale is 3.3 (SD=1.1), and the mean of the Survivorship Care Planning Self-Efficacy scale is 3.9 (SD=1.2). Items are rated from 1=not confident to 5=extremely confident; higher scores suggest greater perceived self-efficacy.
Measured: Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score Change at 6 Months Post-EOT
The 9-item PROMIS Pediatric Scale for Global Health (participant age <18) and 10-item PROMIS Scale for Global Health (participant age 18+) are validated measures of health-related quality of life (HRQoL). Responses are scored on a scale of 1-5, and the total score is converted to a T-score with a mean of 50 and a standard deviation (SD) fixed at 10. Higher scores suggest better perceived HRQoL. The final question on the adult version is scored 1-10.
Measured: Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start20 Aug 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 143 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Hyundai Hope On Wheels
- Responsible party
- Principal investigator, Katie Greenzang,MD, Dana-Farber Cancer Institute
- Investigators
- Katie Greenzang, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07516353
- Sponsor's protocol ID
- 25-603
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center 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.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
- ClinicalTrials.gov ID
- NCT07516353
- Acronym / sponsor ID
- 25-603
- Conditions
- Sarcoma, Osteosarcoma, Ewing Sarcoma, Rhabdomyosarcoma, Acute Myeloid Leukemia, Aml
- Keywords
- Cancer Survivorship, Adolescent and Young Adult Cancer, Late Effects of Cancer Treatment, Hodgkin and mature B-cell Lymphomas, Acute Lymphoblastic Leukemia/Lymphoma, Sarcoma, Osteosarcoma, Ewing Sarcoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 143 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Hyundai Hope On Wheels
- Study start
- 20 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to design and test a novel, personalized digital intervention-my.naviGATE-for adolescent and young adults (AYA) with cancer. my.naviGATE is a mobile app that provides personalized survivorship education, access to virtual peer navigation, and responsive participant-reported outcomes (PROs).
Detailed description
This multi-center, pilot study aims to design and test a novel, personalized digital intervention-my.naviGATE-for adolescent and young adults (AYA) with cancer. My.naviGATE is a mobile app that provides personalized survivorship education, access to virtual peer navigation, and responsive participant-reported outcomes (PROs).
Participants in this research study will be randomized into 1 of 2 study groups: my.naviGATE Group versus Usual Care Group. Randomization means a participant is placed into a study group by chance.
The research study procedures include questionnaires or surveys, use of the mobile app for those randomized to the intervention, and qualitative interviews with study personnel for a subset of participants.
It is expected about 143 people will participate in this research study.
The Hyundai Hope On Wheels Foundation is supporting this research study by providing funding.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| my.naviGATE Group | Experimental | Behavioral: my.naviGATE Digital ToolParticipants will be randomized in a 1:1 ratio to this study group and will complete the following: * Baseline survey * 1 month survey * 6 month survey * Virtual interview (subset of participants) |
| Usual Care Group | No intervention | –Participants will be randomized in a 1:1 ratio to this study group and will receive standard oncology care and will complete the following: * Baseline survey * 1 month survey * 6 month survey |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients aged 15-24 who are currently undergoing cancer treatment at one of the three participating sites: DFCI, CNH, or RPOCH.
- Patients must have initiated and be actively receiving cancer directed therapy for a newly diagnosed cancer.
- Patients must be actively receiving cancer directed therapy, between the time of diagnosis and end of therapy for the following diagnoses: 1) Sarcomas: including osteosarcoma, Ewing sarcoma, and rhabdomyosarcoma; 2) Acute Myeloid Leukemia (AML); 3) Acute Lymphoblastic Leukemia/Lymphoma (ALL); 4) Hodgkin and mature B-cell Lymphomas; and 5) Medulloblastoma.
- Patients whose treatment includes alkylators, anthracyclines, and/or radiation.
- This study is designed to keep AYAs aged 15-24 engaged in cancer survivorship care and therefore a subset of participants will be <18 years of age. The rationale for inclusion of children in this study is that AYA cancer survivors are particularly vulnerable to loss to follow-up and consequently lack of risk-based survivorship care, resulting in increased risk for preventable toxicity. Many existing interventions to improve engagement in survivorship screening and care are introduced after treatment completion and in long-term survivorship. Yet, for patients who are unaware of their late effect risks, and/or those who move frequently and are lost to follow-up, this may be too late. This study is designed to improve awareness of and engagement in risk-informed survivorship care for AYAs. This study presents no more than minimal risk to participants.
Key exclusion criteria (4 listed)
- Patients who are unwilling to give informed consent or assent to participate will be excluded. For patients under 18, patients whose guardians do not give informed consent will be excluded.
- Patients with no chance of cure as identified by the AYA's physician, will be excluded given that issues of survivorship are not relevant and may be distressing to this population. Similarly, patients with relapsed or refractory disease will also be excluded.
- Patients who are non-English-speaking and -reading will be excluded as the digital tool is being developed initially in English.
- We will seek physician permission before offering enrollment to patients. If the provider team requests that the patient not be approached to participate, the patient will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| my.naviGATE Digital Tool: A HIPAA-compliant digital health intervention in the form of a mobile application that provides personalized cancer survivorship education based on individual treatment regimens, virtual visits with trained peer navigators, and collection questionnaires/survey responses. | Behavioural | my.naviGATE Group |
Primary outcome
Change in Patient Activation Measure (PAM)-13 Score from Baseline to 6 Months Post-EOT
Time frame: Assessed at baseline, 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
The Patient Activation Measure (PAM-13) is a validated, self-administered questionnaire assessing knowledge, skills, and confidence for self health-management. It has 13 items with a standardized score from 1-100 derived from 4-point Likert scale answer choices ranging from "Disagree Strongly" to "Agree Strongly;" a higher standardized score represents greater activation.
Application (App) Feasibility Rate (Intervention Group)
Time frame: Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
App feasibility rate is the proportion of participants in the intervention group ever using the my.naviGATE app. Usage metrics are collected through the app development platform.
Application (App) Acceptability Rate (Intervention Group)
Time frame: Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
App acceptability will be assessed in the intervention group with an adapted acceptability electronic (E)-scale for web-based PROs in cancer care. Acceptability rate is the proportion of patients achieving acceptability on the 3-item scale, each using the 5-point Likert scale (1=lowest acceptability/not acceptable to 5 highest acceptability). The score ranges from 3-15 points and a score of 12 or higher indicates acceptability. (Tariman et al. Appl Nurs Res. 2011)
4 secondary outcomes
Patient Assessment of Cancer Communication Experiences (PACE) Scale Score (Treatment Completed Set) at 6 Months Post-EOT
Time frame: Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
Preparedness for Survivorship Score at 6 Months Post-EOT
Time frame: Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
Self-Efficacy Score at 6 Months Post-EOT
Time frame: Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Score Change at 6 Months Post-EOT
Time frame: Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katie Greenzang, MD principal investigator
Dana-Farber Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing my.naviGATE Digital Tool in people with Sarcoma and Osteosarcoma, run by Dana-Farber Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katie Greenzang, MD (6176325992, katie_greenzang@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Patient Activation Measure (PAM)-13 Score from Baseline to 6 Months Post-EOT (time frame: Assessed at baseline, 1-month post EOT (+2 months) and 6-months post EOT (+2 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.