Digital Phenotyping for Psychosocial Screening in Adolescents and Young Adults With Cancer

December 29, 2025 updated by: Stanford University

Using Digital Phenotyping to Optimize Psychosocial Risk Screening and Personalized Care: a Pilot Study in Adolescents and Young Adults With Cancer

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

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
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • Stanford University
        • Contact:
        • Principal Investigator:
          • Victoria Crosgrove, Ph.D.

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:

  • 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

Exclusion Criteria:

  • Significant physical or mental disability that prevents completion of study activities
  • Lack of proficiency in English or Spanish

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: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Digital Phenotyping Arm
All participants (adolescents and young adults with cancer) will receive the digital phenotyping intervention, which includes wearing a smartwatch and using a smartphone-based EMA app over a 10-day period, with psychosocial assessments at baseline, day 10, and 2 months
Device: Device
Participants will wear a wrist-based wearable device for 10 days to passively track physiological data (heart rate, steps, sleep, etc.).
Behavioral: Ecological Momentary Assessment (EMA) via My Personal Health Dashboard (MyPHD) Smartphone App
Participants will respond to ecological momentary assessments (EMA) via smartphone to actively report on sleep, mood, stress, and eating habits across a 10-day period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Depressive Symptoms (Beck Depression Inventory - BDI)
Time Frame: Baseline, Day 10, 2 months
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.
Baseline, Day 10, 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Retention Rate (MyPHD App and Wearable Device)
Time Frame: Baseline to 2 months
Percentage of participants who remain active in the study through the 2-month follow-up period using the MyPHD app and wearable device.
Baseline to 2 months
Adherence to EMA Prompts
Time Frame: Baseline to 2 months
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.
Baseline to 2 months
Wearable Device Return and Use Rate
Time Frame: Baseline to 2 months
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.
Baseline to 2 months
Change in Anxiety Symptoms (Beck Anxiety Inventory - BAI)
Time Frame: Baseline, Day 10, 2 months
Measures changes in self-reported anxiety symptoms across the study period.
Baseline, Day 10, 2 months
Change in PTSD Symptoms (CROPS)
Time Frame: Baseline
PTSD symptoms are measured using the Child Report of Post-traumatic Symptoms (CROPS) for child participants.
Baseline
Change in PTSD Symptoms (PCL-5)
Time Frame: Baseline
PTSD symptoms are measured using the PTSD Checklist for DSM-5 (PCL-5) for general population participants.
Baseline
Change in Sleep Quality (Pittsburgh Sleep Quality Index - PSQI)
Time Frame: Baseline, Day 10
Assesses subjective sleep quality and patterns.
Baseline, Day 10

Collaborators and Investigators

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

Sponsor

Stanford University

Investigators

  • Principal Investigator: Victoria Cosgrove, PhD, Stanford University

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 (Actual)

January 29, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 9, 2025

First Submitted That Met QC Criteria

October 21, 2025

First Posted (Estimated)

October 23, 2025

Study Record Updates

Last Update Posted (Actual)

December 30, 2025

Last Update Submitted That Met QC Criteria

December 29, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-73748

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.

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