Assessing the Acceptability of the Use of a Mobile Health App Among Young Adult Female Survivors of Childhood Cancer

Assessing the Acceptability of the Use of a Mobile Health App Among Young Adult Female Survivors of Childhood Cancer: A Feasibility Study

The purpose of this research study is to understand if a mobile app is useful to assist young adult female survivors of childhood cancer in the self-management of survivorship-related needs.

Study Overview

• Status: Completed
• Conditions: Childhood Cancer Survivor
• Intervention / Treatment: Other: Mobile Health App

Detailed Description

Survivorship related needs include managing lingering symptoms from treatment, how to keep a healthy lifestyle, social and medical issues, as well as other needs. The mobile health app that will be used in this study is the Health Storylines TM app developed by Self Care Catalysts Inc. The app can be used for an unlimited amount of time over nine months, which is how long the study will be conducted. The use of the Health Storylines TM app in this study is investigational.

Participation in this study starts with setting up a study specific profile on the app and entering information including email address, age, ethnicity/race, cancer diagnosis, as well as other optional information for the profile (example health goals or current health conditions). Participants will then be prompted by the app to complete three questionnaires about their ability to self-manage their survivorship-related needs, their perception of their survivorship-related illness symptoms and perceived health related quality of life. They will be prompted on the app to complete these questionnaires again at the 3, 6 and 9 month intervals of using the app. It will take about 20 minutes to complete the questionnaires at each measurement time. The only additional information that will be reported from the app for the study is the amount of time and features of programs accessed during the study period.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion criteria are females who:

• Have been diagnosed with cancer before the age of 18 years
• Are between the ages 18 to 30 years
• Have been off treatment for at least six months
• Have a personal smart device to use for the app

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Mobile Health App; Participants will be prompted to complete questionnaires.	Other: Mobile Health App; Mobile Health is a multi-featured app designed to enable participants to self-record and track their health and wellness. Participations will set up a profile and complete questionnaires. The app also records the amount of time and features of programs accessed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of mHealth app as measured by tracking all activities conducted on the app	Assess the feasibility of the mHealth app as measured by tracking all activities of the patient-centered mHealth health tracking app, Health StorylinesTM, in young adult female survivors	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence	Assess the adherence to study procedures including baseline and follow-up assessments as measured by completion rates of required tasks	Up to 2 years
Self-Efficacy	Determine the association between the amount of usage (in minutes), the frequency of usage number of times accessed) of the Health StorylinesTM mhealth app, and self-efficacy in young adult female survivors of childhood cancer.	Up to 2 years
Health Related Quality of Life	Determine the association between the amount of usage (in minutes), the frequency of usage number of times accessed) of the Health StorylinesTM mhealth app and health related quality of life in young adult female survivors of childhood cancer	Up to 2 years
Perceived Illness	Determine the association between the amount of usage (in minutes), the frequency of usage number of times accessed) of the Health StorylinesTM mhealth app and perceived illness in young adult female survivors of childhood cancer.	Up to 2 years

Collaborators and Investigators

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Collaborators: Oncology Nursing Society; Villanova University
• Investigators: Principal Investigator: Kathy Ruble, RN, PhD, Johns Hopkins University

Publications and helpful links

Helpful Links

• Self Care Catalysts

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2017
• Primary Completion (Actual): March 11, 2021
• Study Completion (Actual): March 11, 2021

Study Registration Dates

• First Submitted: July 17, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (Actual): August 8, 2017

Study Record Updates

• Last Update Posted (Actual): April 1, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: questionnaire; mobile app; survivors of childhood cancer; young adult female; health tracking
• Other Study ID Numbers: J1734; IRB00126543 (Other Identifier: JHM IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No