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Smart-phone Application to Promote Medication Adherence in Adolescents and Young Adults (AYA) With Cancer

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ClinicalTrials.gov Identifier: NCT01618344
Recruitment Status : Completed
First Posted : June 13, 2012
Results First Posted : November 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
To explore use of a smart-phone medication reminder application to promote adherence to oral medications by AYA with cancer.

Condition or disease
Neoplasms

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 smart-phone 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 smart-phone 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 smart-phone 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 generalized estimating equation (GEE) modeling.

Study Design

Study Type : Observational
Actual Enrollment : 32 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Use of a Smart-phone Medication Reminder Application to Promote Adherence to Oral Medications by Adolescents and Young Adults(AYA) With Cancer
Study Start Date : May 2012
Primary Completion Date : December 2016
Study Completion Date : February 2017
Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. Feasibility and Acceptability of Using a Smart-phone Medication Reminder Application to Promote Adherence to Oral Medications by AYA With Cancer. [ Time Frame: ongoing study weeks 5-12 ]
    Feasibility was assessed through participants' application usage and responses to self-reported questions about their use of the application. Acceptability was assessed through participants' perceived ease of use and perceived usefulness of the application.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
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 smart-phone medication reminder application-

Exclusion Criteria:

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

Contacts and Locations

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): NCT01618344


Locations
United States, Utah
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
University of Utah
Oncology Nursing Society Foundation
Investigators
Principal Investigator: Yelena Wu, PhD Huntsman Cancer Institute
Principal Investigator: Lauri Linder, PhD University of Utah
  Study Documents (Full-Text)

Documents provided by Yelena Wu, 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
First Posted: June 13, 2012    Key Record Dates
Results First Posted: November 6, 2017
Last Update Posted: November 6, 2017
Last Verified: October 2017

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