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

March 31, 2026 updated by: Katie Greenzang,MD, Dana-Farber Cancer Institute
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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

143

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana Farber Cancer Institute
        • Contact:
        • Principal Investigator:
          • Katie Greenzang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: my.naviGATE Group

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
: 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.
No Intervention: Usual Care Group

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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at baseline, 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
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.
Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
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)
Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
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)
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.
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)
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.
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)
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.
Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dana-Farber Cancer Institute

Collaborators

Hyundai Hope On Wheels

Investigators

  • Principal Investigator: Katie Greenzang, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 20, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

March 31, 2026

First Submitted That Met QC Criteria

March 31, 2026

First Posted (Actual)

April 8, 2026

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-603

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data can be shared no earlier than 1 year following the date of publication

IPD Sharing Access Criteria

DFCI- Contact the Beffer office for Dana -Farber Innovations (BODFI) at innovations@dfci.harvard.edu

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sarcoma

Clinical Trials on my.naviGATE Digital Tool

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe