- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05000359
A Mobile Phone Intervention to Promote Adherence to Survivorship Care Among Adolescent and Young Adult Cancer Survivors
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- University of California at Los Angeles
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: AYA Text messaging intervention
Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention.
|
Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mobil Phone Muti-Media messaging
Time Frame: one month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Key Informant Interview regarding risk for late effects due to prior cancer treatment and intent to seek survivorship care.
Time Frame: up to 1 year
|
Themes for refinement of the text messaging intervention as assessed by key informant interview questions designed to elicit feedback on features of the mobile phone intervention that could improve knowledge regarding risk for late effects and intent to seek survivorship care. Hypothetical example: Collectively, participants believed that the intervention's incorporation of weblinks and phone numbers to community resources clarified their risk for late effects as a cancer survivor. |
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.
Time Frame: up to 1 year
|
Key informant interviews with YA survivors regarding their experience during the mobile phone intervention will 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. Theoretical example: Collectively, participants believed the appointment reminders provided by the mobile phone intervention made it more likely for them to attend their survivorship care clinic appointment and, thus, complete their ASAP goal (adherence to survivorship care). |
up to 1 year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Mark C Garcia, MD, University of California, Los Angeles
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 21-000440
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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