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

January 9, 2024 updated by: Abramson Cancer Center at Penn Medicine

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.

Study Overview

Status

Active, not recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Abramson Cancer Center of the University of Pennsylvania

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

15 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

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

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Christine Hill-Kayser, MD, Abramson Cancer Center at Penn Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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)

March 1, 2017

Primary Completion (Actual)

December 1, 2019

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

December 1, 2017

First Submitted That Met QC Criteria

December 1, 2017

First Posted (Actual)

December 6, 2017

Study Record Updates

Last Update Posted (Actual)

January 10, 2024

Last Update Submitted That Met QC Criteria

January 9, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • UPCC 26916

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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