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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03242200
Recruitment Status : Completed
First Posted : August 8, 2017
Last Update Posted : April 1, 2021
Sponsor:
Collaborators:
Villanova University
Oncology Nursing Society
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Description
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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.

Condition or disease Intervention/treatment Phase
Childhood Cancer Survivor Other: Mobile Health App Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Assessing the Acceptability of the Use of a Mobile Health App Among Young Adult Female Survivors of Childhood Cancer: A Feasibility Study
Actual Study Start Date : September 26, 2017
Actual Primary Completion Date : March 11, 2021
Actual Study Completion Date : March 11, 2021
Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility of mHealth app as measured by tracking all activities conducted on the app [ Time Frame: Up to 2 years ]
    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


Secondary Outcome Measures :
  1. Adherence [ Time Frame: Up to 2 years ]
    Assess the adherence to study procedures including baseline and follow-up assessments as measured by completion rates of required tasks

  2. Self-Efficacy [ Time Frame: Up to 2 years ]
    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.

  3. Health Related Quality of Life [ Time Frame: Up to 2 years ]
    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

  4. Perceived Illness [ Time Frame: Up to 2 years ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female survivors of childhood cancer
Accepts Healthy Volunteers:   Yes
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

Contacts and Locations
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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): NCT03242200


Locations
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United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Villanova University
Oncology Nursing Society
Investigators
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Principal Investigator: Kathy Ruble, RN, PhD Johns Hopkins University
More Information
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Additional Information:

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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT03242200    
Other Study ID Numbers: J1734
IRB00126543 ( Other Identifier: JHM IRB )
First Posted: August 8, 2017    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: August 2020
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
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
survivors of childhood cancer
young adult female
mobile app
questionnaire
health tracking