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A Mobile Phone Intervention to Promote Adherence to Survivorship Care Among Adolescent and Young Adult Cancer Survivors

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ClinicalTrials.gov Identifier: NCT05000359
Recruitment Status : Recruiting
First Posted : August 11, 2021
Last Update Posted : August 11, 2021
Sponsor:
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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.


Condition or disease Intervention/treatment Phase
Survivors of Childhood Cancer Behavioral: text messaging intervention Early Phase 1

Detailed Description:
Aim 1: To adapt and enhance an existing text messaging intervention to an expanded two-way multi-media mobile phone messaging platform (Chorus) that will improve knowledge regarding the risk of late effects among AYA survivors, intent to seek recommended survivorship care, and completion of standard survivorship care goals. a. both two-way text messaging to improve Children?s Oncology Group (COG) survivorship guideline adherence b. web-based educational content for survivors of key survivorship messages regarding risk for late effects and need for ongoing survivorship care c. Monthly peer navigation phone calls to address barriers and promote retention d. utilization of pre and post-test questionnaires for participants to access and complete within the Chorus platform Aim 2: To test the acceptability and feasibility of the expanded mobile phone intervention content to improve messaging and strategies for survivorship care using qualitative methodologies and applying the Technology Acceptance Model (TAM) within a sample of AYA survivors. a. perceived usefulness of the text messaging system b. perceived ease of use of the text messaging system c. effect of the text messaging system on health-related behavior intent

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention.
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: A Mobile Phone Intervention to Promote Adherence to Survivorship Care Among Adolescent and Young Adult Cancer Survivors
Actual Study Start Date : July 12, 2021
Estimated Primary Completion Date : July 30, 2022
Estimated Study Completion Date : July 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
AYA Text messaging intervention
Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention.
Behavioral: text messaging intervention
Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention.




Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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).




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05000359


Contacts
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Contact: Mark C. Garcia, MD 310-825-6708 markcgarcia@mednet.ucla.edu

Locations
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United States, California
University of California at Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Mark C. Garcia, MD    310-825-6708    markcgarcia@mednet.ucla.edu   
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
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Principal Investigator: Jacqueline Casillas, MD University of California, Los Angeles
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT05000359    
Other Study ID Numbers: 21-000440
First Posted: August 11, 2021    Key Record Dates
Last Update Posted: August 11, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No