Clinical trial · Interventional
my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults
NCT07516353CI-TRIAL-00107568not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Lymphoblastic Leukemia ,Lymphomas | Acute Lymphoblastic Leukemia | ONTOLOGY_EXACT | 0.85 |
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| ALL | Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
| Aml | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Ewing Sarcoma | Ewing Sarcoma | ONTOLOGY_EXACT | 0.98 |
| Medulloblastoma | Medulloblastoma | CURATED_BROADER | 0.80 |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
| Rhabdomyosarcoma | Rhabdomyosarcoma | ONTOLOGY_EXACT | 0.90 |
| Sarcoma | Sarcoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| my.naviGATE Digital Tool | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- my.naviGATE Group
- description
- 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)
- interventionNames
- Behavioral: my.naviGATE Digital Tool
- type
- NO_INTERVENTION
- label
- Usual Care Group
- description
- 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
Primary outcomes (3)
- measure
- Change in Patient Activation Measure (PAM)-13 Score from Baseline to 6 Months Post-EOT
- timeFrame
- Assessed at baseline, 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 24 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Inclusion of Children: • 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.