Clinical trial NCT03242200: Assessing the Acceptability of the Use of a Mobile Health App Among Young Adult Female Survivors of Childhood Cancer
Official title: Assessing the Acceptability of the Use of a Mobile Health App Among Young Adult Female Survivors of Childhood Cancer: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Cancer Survivor
Keywords: survivors of childhood cancer
young adult female
mobile app
questionnaire
health tracking
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: Villanova University
name: Oncology Nursing Society
First posted: 2017-08-08
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This project is a longitudinal one-group pilot study evaluating the use of a Mobile Health (mHealth) app intervention. This study will examine: 1) the amount/type of usage, 2 ) compliance with study evaluations and 3) the association of this mHealth app use with perceived self-efficacy in managing survivorship related needs, perceived health illness and health related quality of life. The study period will be nine months, with four measurement points to assess the study's outcomes: baseline, three, six, and nine months post initiation of the mHealth app.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of mHealth app as measured by tracking all activities conducted on the app
timeFrame: Up to 2 years
Secondary outcomes:
measure: Adherence
timeFrame: Up to 2 years
measure: Self-Efficacy
timeFrame: Up to 2 years
measure: Health Related Quality of Life
timeFrame: Up to 2 years
measure: Perceived Illness
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kathy Ruble, RN, PhD
role: PRINCIPAL_INVESTIGATOR
References: