NCT05000359

Brief Summary

Adolescents and young adults (AYA) survivors of childhood cancer receive inadequate surveillance for treatment-related late effects. This study evaluates the acceptability and feasibility of a mobile phone messaging intervention targeting behavior changes related to receiving survivorship care among AYA survivors. Content from an existing text-messaging survivorship education intervention will be adapted to a novel text-messaging platform, Chorus. Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention. In-depth interviews will be conducted with each participant during the study, and a focus group with all participants will be conducted at the end of the study. Qualitative analysis will determine areas for improvement in the text messaging intervention in order to ensure acceptability and feasibility in AYA survivors. The text messaging intervention on Chorus will be adapted to better suit the needs of AYA survivors based on the results of the qualitative analysis. Mobile phone interventions offer a cost-effective, age-appropriate approach to AYA survivorship care education. If effective, the text-messaging intervention will be evaluated in a randomized, controlled pilot trial to improve rates of survivorship care and clinical outcomes for AYA survivors.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2021

Completed
3 days until next milestone

Study Start

First participant enrolled

July 12, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2023

Completed
Last Updated

July 12, 2023

Status Verified

July 1, 2023

Enrollment Period

2 years

First QC Date

July 9, 2021

Last Update Submit

July 10, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mobil Phone Muti-Media messaging

    Acceptability and feasibility of an expanded mobile phone intervention as assessed by key informant interview questions and a focus group discussion developed based on the Technology Acceptance Model: (a) perceived usefulness of the text messaging system for completing ASAP goals, (b) perceived ease of use of the text messaging system for completing ASAP goals, and (c) effect of the text messaging system on intent to complete ASAP goals. The assessment will be qualitative only. The Technology Acceptance Model (TAM) evaluates how likely a user of new technology will accept and continue to use the new technology. TAM posits that if the technology is perceived as useful, easy to use, and increases intent to use - then the technology is more likely to be accepted. Interview questions and focus group discussion points will ask about these criteria. If responses satisfy the TAM criteria, this supports mobile phone intervention as acceptable and feasible for use in AYA cancer survivors.

    one month

Secondary Outcomes (2)

  • Key Informant Interview regarding risk for late effects due to prior cancer treatment and intent to seek survivorship care.

    up to 1 year

  • Key Informant Interview to identify themes from which the mobile phone intervention will be refined in order to improve its potential impact on the completion of participants' Adolescent and Young Adult Survivorship Action Plan (ASAP) goals.

    up to 1 year

Study Arms (1)

AYA Text messaging intervention

OTHER

Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention.

Behavioral: text messaging intervention

Interventions

Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention.

AYA Text messaging intervention

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients must be between the ages of 18 to 39 years at the time of enrollment
  • Patient must reside in the greater Los Angeles area.
  • Patients must have received survivorship care at the University of California at Los Angeles (UCLA)
  • Patients must be fluent in English.
  • Patients must be off cancer therapy for at least one year.
  • Patients must have personal access to a smart phone with text messaging and internet and/or data capability.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California at Los Angeles

Los Angeles, California, 90095, United States

Location

Study Officials

  • Mark C Garcia, MD

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2021

First Posted

August 11, 2021

Study Start

July 12, 2021

Primary Completion

July 3, 2023

Study Completion

July 3, 2023

Last Updated

July 12, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations