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).
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
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
143
: 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.
Dana Farber Cancer Institute
Boston, Massachusetts, United States
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.
Time frame: 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.
Time frame: 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)
Time frame: Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
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.
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
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.
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
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.
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
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.
Time frame: Assessed at 1-month post EOT (+2 months) and 6-months post EOT (+2 months)
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