Smartphone Application to Promote Medication Adherence in Adolescents and Young Adults (AYA) With Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Seattle Children's Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Seattle Children's Hospital
ClinicalTrials.gov Identifier:
NCT01618344
First received: April 25, 2012
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

To explore use of a smartphone medication reminder application to promote adherence to oral medications by AYA with cancer.


Condition Intervention
Neoplasms
Behavioral: Smart phone medication reminder application

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Use of a Smartphone Medication Reminder Application to Promote Adherence to Oral Medications by Adolescents and Young Adults(AYA) With Cancer

Resource links provided by NLM:


Further study details as provided by Seattle Children's Hospital:

Primary Outcome Measures:
  • Feasibility and acceptability of using a smartphone medication reminder application to promote adherence to oral medications by AYA with cancer. [ Time Frame: ongoing study weeks 5-12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: May 2012
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Smart phone medication reminder application
    The study intervention will consist of reminders delivered via a smartphone medication reminder application at the time a dose of medication is due. The application to be used is Dosecast (copyright 2011, Montuno Software, LLC) which is publicly available for purchase through the App Store. Participant compensation for study participation will take into account the cost to participants (less than $5) of purchasing the application and participants will receive instruction from the study Clinical Research Associate (CRA) in programming it to deliver audio and visual reminders when a dose of a scheduled oral medication is due and in entering a response to reminders received (medication taken, skipped, or re-reminder requested at a specific time interval). Participants will use the smartphone medication reminder application over an 8 week period for all scheduled oral medications to be taken while outpatient.
Detailed Description:

Non-adherence to oral medications is a prevalent problem in adolescents and young adults (AYA) with cancer that may impact both survival and quality of life while on treatment. The purpose of this study is to explore use of a smartphone medication reminder application to promote adherence to oral medications by AYA with cancer. The study's primary aim is to explore the feasibility and acceptability of using a smartphone medication reminder application to promote adherence to oral medications by AYA with cancer as well as to characterize application use. Secondary aims include: 1) to obtain initial estimates of intervention effect- measured by pre-intervention to post-intervention differences in perceived behavioral control for adherence, intention to adhere, and adherence behavior - to inform design of a future trial powered to detect a clinically significant effect of smartphone medication reminder application use on adherence to oral medications; and 2) to examine the relationships among perceived behavioral control for adherence, intention to adhere, and adherence behavior. A pre-post single group design will be used. Data will be collected weekly for 4 weeks before introduction of the intervention and for 8 weeks following introduction of the intervention. Analytic approaches will include descriptive statistics and GEE modeling.

  Eligibility

Ages Eligible for Study:   15 Years to 29 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

1)15-29 year olds receiving treatment for any type of cancer, either primary or recurrent/relapsed disease, at Seattle Children's Hospital

2) Patient has completed at least one month of therapy

3)Patient is expected to remain on therapy for 3 month duration of study

4) Patient has an iPhone, iPad, or iTouch running iOS 4.0 or later

5) Patient is willing to use a smartphone medication reminder application-

Exclusion Criteria:

1)Patients who are unable to speak/read/write English as required for use of smartphone medication reminder application and completion of study measures.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01618344

Contacts
Contact: Rebecca H Johnson, MD 206-987-2552 rebecca.johnson@seattlechildrens.org
Contact: Catherine Fiona Macpherson, PhD 206-987-2032 catherine.macpherson@seattlechildrens.org

Locations
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Principal Investigator: Rebecca H Johnson, MD         
Principal Investigator: Catherine Fiona Macpherson, PhD         
Sponsors and Collaborators
Seattle Children's Hospital
Investigators
Principal Investigator: Rebecca H Johnson, MD Seattle Children's Hospital
Principal Investigator: Catherine Fiona Macpherson, PhD Seattle Children's Hospital
  More Information

No publications provided

Responsible Party: Seattle Children's Hospital
ClinicalTrials.gov Identifier: NCT01618344     History of Changes
Other Study ID Numbers: SCH-13929
Study First Received: April 25, 2012
Last Updated: June 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Seattle Children's Hospital:
neoplasms
adolescent
young adult
medication adherence

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014