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Mobile App to Help Survivors of Childhood Cancer Navigate Long-Term Follow-Up Care

Sponsor
University of California, San Francisco (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05641961
Collaborator
Swim Across America (Other)
30
Enrollment
1
Location
1
Arm
16
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical trial studies the effectiveness of a newly developed survivorship mobile application (app) designed for survivors, or their caregivers, of childhood cancer to help them better navigate long-term follow-up care. The survivorship app provides survivors access to their treatment history and follow-up recommendations, improves knowledge of their diagnosis, treatment, risks, and recommended follow-up care by using a message notification. The ability to quickly connect and establish care planning may enhance adherence to recommended follow-up.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Survivorship mobile application
  • Other: Questionnaires
 N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. To determine the difference in survivor/caregiver knowledge and understanding of diagnosis, treatment information, and follow-up needs using the survivorship app.
SECONDARY OBJECTIVE:
  1. To validate the usability and effectiveness of the survivorship mobile application.
OUTLINE:

Participants are seen in the survivorship clinic and receive education about potential late effects and the survivorship application on study. Participants then use the survivorship app for 4 months on study.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Utilizing a Mobile App to Help Survivors of Childhood Cancer Navigate Long-Term Follow-Up Care
Anticipated Study Start Date :
Dec 31, 2022
Anticipated Primary Completion Date :
Apr 30, 2024
Anticipated Study Completion Date :
Apr 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Survivorship Mobile Application

Participants are seen in the survivorship clinic and receive education about potential late effects and the survivorship application on study. Participants enrolled in this study will be asked to complete two self-administered questionnaires at 4 time points. Questionnaires will be designed and made available electronically, to be completed on the participant's personal mobile device (e.g., mobile phone).

Behavioral: Survivorship mobile application
Mobile phone application
Other Names:
  • Survivorship App

    • Other: Questionnaires
    Questionnaires assessing cancer knowledge and system usability will be delivered to participants via Survivorship App

    Outcome Measures

    Primary Outcome Measures

    1. Change in knowledge questionnaire score [Up to 4 months]

      The knowledge of the participant will be measured using a 12-item questionnaire that assesses the awareness of their treatment and health issues in four categories: (1) diagnosis, (2) treatment, (3) risks, and (4) recommended follow-up. A scoring system has been devised which will give a score to each questionnaire out of 100 possible points. The change in participants knowledge scores >=20 points from baseline will be reported.

    Secondary Outcome Measures

    1. System usability scale (SUS) score > 68 [Up to 2 months]

      System Usability Scale (SUS) consists of a 10-item survey with five response options from Strongly agree to Strongly disagree. The scoring of positive questions is done as follows: The user's score is reduced by one point. For example, if the user's score is 4 for question 5, then the outcome score will be 3. The scoring of negative questions is done as follows: The user's score is subtracted from 5. For example, if the user's score is 3 for question 4, then the new score will be 2. After all the scores are determined, the sum of the scores is multiplied by 2.5 to make the range between 0 and 100. Scores above 68 are considered above average. The proportion of participants with an acceptable usability score > 68 will be reported.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Survivors of childhood cancer attending Survivorship Clinic at University of California, San Francisco (UCSF) OR caregivers of a childhood cancer survivor attending Survivorship Clinic at UCSF.

    • Must have a mobile device (smartphone or smart-tablet) with service plan.

    • Must have ability to read, write, and understand English language.

    Exclusion Criteria:
    • An individual who does not meet any of the criteria mentioned above will be excluded from participation in this study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, San Francisco San Francisco California United States 94143

    Sponsors and Collaborators

    • University of California, San Francisco
    • Swim Across America

    Investigators

    • Principal Investigator: Robert Goldsby, MD, University of California, San Francisco

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, San Francisco
    ClinicalTrials.gov Identifier:
    NCT05641961
    Other Study ID Numbers:
    • 220813
    • NCI-2022-09452
    First Posted:
    Dec 8, 2022
    Last Update Posted:
    Dec 8, 2022
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Dec 8, 2022