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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yelena Wu, University of Utah
ClinicalTrials.gov Identifier:
NCT01618344
First received: April 25, 2012
Last updated: August 22, 2016
Last verified: August 2016
  Purpose
To explore use of a smartphone medication reminder application to promote adherence to oral medications by AYA with cancer.

Condition Phase
Neoplasms
Phase 0

Study Type: Observational
Study Design: Time Perspective: Prospective
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 University of Utah:

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: 34
Study Start Date: May 2012
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
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   (Child, Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinics for patients be treated for cancer.
Criteria

Inclusion criteria:

1)15-29 year olds receiving treatment for any type of cancer, either primary or recurrent/relapsed disease.

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

Locations
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Yelena Wu, MD Huntsman Cancer Institute
Principal Investigator: Lauri Linder, PhD University of Utah
  More Information

Responsible Party: Yelena Wu, Principal Investigator, University of Utah
ClinicalTrials.gov Identifier: NCT01618344     History of Changes
Other Study ID Numbers: SCH-13929 
Study First Received: April 25, 2012
Last Updated: August 22, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
neoplasms
adolescent
young adult
medication adherence

ClinicalTrials.gov processed this record on August 28, 2016