Digital Phenotyping for Psychosocial Screening in Adolescents and Young Adults With Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age10-25
SponsorStanford University
About this trial
The overall goal of the proposed study is to use digital phenotyping to identify and triage at-risk patients and accelerate access to critical mental health services.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
10-25 years old
Recent cancer diagnosis (>2 and <18 months since diagnosis)
Willing to carry smartphone on their person for duration of study participation
Willing to wear smartwatch for duration of study participation
Disqualifiers
Significant physical or mental disability that prevents completion of study activities
Lack of proficiency in English or Spanish
Trial design
Design model
Single group
Treatments tested in this trial
Device
DeviceParticipants will wear a wrist-based wearable device for 10 days to passively track physiological data (heart rate, steps, sleep, etc.).
Ecological Momentary Assessment (EMA) via My Personal Health Dashboard (MyPHD) Smartphone App
BehavioralParticipants will respond to ecological momentary assessments (EMA) via smartphone to actively report on sleep, mood, stress, and eating habits across a 10-day period.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Digital Phenotyping ArmExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Change in Depressive Symptoms (Beck Depression Inventory - BDI)
The Beck Depression Inventory-II (BDI-II; range 0-63) will be used to measure changes in depressive symptoms among adolescents and young adults over time. Higher scores indicate greater depressive symptom severity.
Time frame
Baseline, Day 10, 2 monthsSecondary outcomes
1
Participant Retention Rate (MyPHD App and Wearable Device)
Percentage of participants who remain active in the study through the 2-month follow-up period using the MyPHD app and wearable device.
Time frame
Baseline to 2 months2
Adherence to EMA Prompts
Mean percentage of EMA prompts completed by participants using the MyPHD mobile app during the 2-month study period. Completion will be assessed via EMA system analytics.
Time frame
Baseline to 2 months3
Wearable Device Return and Use Rate
Percentage of participants who return and use the wearable device as instructed during the study period. Device use will be tracked through backend device usage logs.
Time frame
Baseline to 2 months4
Change in Anxiety Symptoms (Beck Anxiety Inventory - BAI)
Measures changes in self-reported anxiety symptoms across the study period.
Time frame
Baseline, Day 10, 2 monthsSponsors and contacts
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Source ClinicalTrials.gov