NCT03242200

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

September 26, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 11, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2021

Completed
Last Updated

April 1, 2021

Status Verified

August 1, 2020

Enrollment Period

3.5 years

First QC Date

July 17, 2017

Last Update Submit

March 29, 2021

Conditions

Keywords

survivors of childhood canceryoung adult femalemobile appquestionnairehealth tracking

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Adherence

    Up to 2 years

  • Self-Efficacy

    Up to 2 years

  • Health Related Quality of Life

    Up to 2 years

  • Perceived Illness

    Up to 2 years

Study Arms (1)

Mobile Health App

OTHER

Participants will be prompted to complete questionnaires.

Other: Mobile Health App

Interventions

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.

Mobile Health App

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale survivors of childhood cancer
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Study Officials

  • Kathy Ruble, RN, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2017

First Posted

August 8, 2017

Study Start

September 26, 2017

Primary Completion

March 11, 2021

Study Completion

March 11, 2021

Last Updated

April 1, 2021

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations