AYA STEPS RCT: AYA Self-Management Via Texting, Education... | NCT03363711

Studies
AYA STEPS RCT: AYA Self-Management Via Texting, Education & Plans for Survivors

NCT03363711

Sponsor

Abramson Cancer Center at Penn Medicine

Status

Active, not recruiting

Last Update Posted

Jan 8, 2026Actual

Enrollment

25Actual

Phase

Not provided

Conditions

Adolescent and Young Adult (AYA) Cancer Survivors

Interventions

AYA STEPS

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 1, 2017Actual

Primary Completion Date

Dec 1, 2019Actual

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Dec 1, 2017

First Submission Date that Met QC Criteria

Dec 1, 2017

First Posted Date

Dec 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 7, 2026

Last Update Posted Date

Jan 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The proposed project will leverage two programs of research at UPenn and CHOP that are delivering technology-based interventions to adolescent and young adult (AYA) cancer survivors.

In the proposed study, all AYA survivors will receive a care plan via a tool (Smart-ALACC). They will then be randomized to receive (or not) a mobile health application (AYA STEPS) that will provide tailored messages to enhance uptake of their care plan.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Name	Type	Description	Arm Group Labels	Other Names
AYA STEPS	Other	a mobile health application

Measure	Description	Time Frame
Number of Completed mobile data and questionnaires		10 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

AYA is 15-29 year old with a history of a malignant cancer diagnosis;
Completed cancer treatment and are currently in remission or receiving cancer survivorship care;
Seen for follow-up oncology care at CHOP or Penn;
For AYA less than 18 years old, must have a caregiver to provide informed consent.

Exclusion Criteria:

Cognitive impairments that would limit AYA ability to independently care for health as determined by the medical team.
Absence of the inclusion criteria

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

29 Years

Standard Ages

ChildAdult

Study Population

15-29 year olds with a history of malignant cancer diagnosis.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christine Hill-Kayser, MD	Abramson Cancer Center at Penn Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Abramson Cancer Center of the University of Pennsylvania		Philadelphia	Pennsylvania	19104	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40719621	Derived	Darabos K, Deatrick JA, Wolk CB, O'Hagan B, King-Dowling S, Szalda D, Hobbie W, Barakat LP, Hill-Kayser C, Schwartz LA. Perspectives on Care Plans for Adolescent and Young Adult Survivors of Childhood Cancer: A Qualitative Evaluation of Survivors, Caregivers, and Oncology and Primary Care Practitioners. J Adolesc Young Adult Oncol. 2026 Apr;15(2):115-123. doi: 10.1177/21565333251362113. Epub 2026 Mar 10.
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