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

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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)]
• Application (App) Feasibility Rate (Intervention Group) [Time frame: 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)]

Secondary outcome measures (4)

• 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)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Health services research

Study locations

United States · 1 center

• Dana Farber Cancer Institute — Boston

Identifiers

NCT: NCT07516353 · 25-603

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗