NCT07220343

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable cancer

Timeline
5mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jan 2025Dec 2026

Study Start

First participant enrolled

January 29, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 23, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

December 30, 2025

Status Verified

December 1, 2025

Enrollment Period

1.8 years

First QC Date

September 9, 2025

Last Update Submit

December 29, 2025

Conditions

Keywords

SmartphoneCancer

Outcome Measures

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.

    Baseline, Day 10, 2 months

Secondary Outcomes (7)

  • Participant Retention Rate (MyPHD App and Wearable Device)

    Baseline to 2 months

  • Adherence to EMA Prompts

    Baseline to 2 months

  • Wearable Device Return and Use Rate

    Baseline to 2 months

  • Change in Anxiety Symptoms (Beck Anxiety Inventory - BAI)

    Baseline, Day 10, 2 months

  • Change in PTSD Symptoms (CROPS)

    Baseline

  • +2 more secondary outcomes

Study Arms (1)

Digital Phenotyping Arm

EXPERIMENTAL

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: DeviceBehavioral: Ecological Momentary Assessment (EMA) via My Personal Health Dashboard (MyPHD) Smartphone App

Interventions

DeviceDEVICE

Participants will wear a wrist-based wearable device for 10 days to passively track physiological data (heart rate, steps, sleep, etc.).

Digital Phenotyping Arm

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.

Digital Phenotyping Arm

Eligibility Criteria

Age10 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Equipment and SuppliesEcological Momentary Assessment

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Victoria Cosgrove, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2025

First Posted

October 23, 2025

Study Start

January 29, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

December 30, 2025

Record last verified: 2025-12

Locations