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).
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.
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.
Parallel
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.
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.
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.
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)
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.
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.
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.
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.
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Dana-Farber Cancer Institute
Lead sponsor
Hyundai Hope On Wheels
Collaborator
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