my.naviGATE: A Guide to After-Treatment Effects for Adolescents and Young Adults

NCT07516353 | Not Yet Recruiting DMC

• 1 other identifier: 25-603
• Study Type: interventional
• Target: 143
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Sarcoma; Osteosarcoma; Ewing Sarcoma; Rhabdomyosarcoma; Acute Myeloid Leukemia; Aml; ALL; Medulloblastoma; Acute Lymphoblastic Leukemia ,Lymphomas

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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)

  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

  Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)

• Preparedness for Survivorship Score at 6 Months Post-EOT

  Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)

• Self-Efficacy Score at 6 Months Post-EOT

  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

  Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)

Study Arms (2)

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)

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

Interventions

my.naviGATE Digital Tool BEHAVIORAL

: 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.

my.naviGATE Group

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hyundai Hope On Wheels: collaborator
• Dana-Farber Cancer Institute: lead

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Sarcoma; Osteosarcoma; Sarcoma, Ewing; Rhabdomyosarcoma; Leukemia, Myeloid, Acute; Medulloblastoma; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Myosarcoma; Neoplasms, Muscle Tissue; Leukemia, Myeloid; Leukemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neuroectodermal Tumors, Primitive; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Katie Greenzang, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katie Greenzang, MD

CONTACT

6176325992; katie_greenzang@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Sponsor-Investigator

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 8, 2026
• Study Start (Estimated): August 20, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 8, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: DFCI- Contact the Beffer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu

Locations

US (1)