NeoplasmsNCT01618344
Smart-phone Application to Promote Medication Adherence in Adolescents and Young Adults (AYA) With Cancer
An observational study of Neoplasms, run by University of Utah at 1 site in United States.
Trial summary
To explore use of a smart-phone medication reminder application to promote adherence to oral medications by AYA with cancer. Read more about this study
- Who is it for?
- Ages 15 to 29 years
- Conditions the study is for
- Neoplasms
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Feb 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 29 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Primary care clinics for patients be treated for cancer.
Who may be able to join
- 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-
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: Use of a Smart-phone Medication Reminder Application to Promote Adherence to Oral Medications by Adolescents and Young Adults(AYA) With Cancer
To explore use of a smart-phone medication reminder application to promote adherence to oral medications by AYA with cancer.
Read the 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.
- Conditions
- Neoplasms
- Keywords
- neoplasms, adolescent, young adult, medication adherence
- Medical subject headings
- Neoplasms, Medication Adherence
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Acceptability of Using a Smart-phone Medication Reminder Application to Promote Adherence to Oral Medications by AYA With Cancer.
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.
Measured: ongoing study weeks 5-12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Oncology Nursing Society
- Responsible party
- Principal investigator, Yelena Wu, University of Utah
- Investigators
- Yelena Wu, PhD, Principal investigator, Huntsman Cancer InstituteLauri Linder, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01618344
- Sponsor's protocol ID
- SCH-13929
- Status last verified
- Oct 2017
- First submitted
- 25 Apr 2012
- Last updated
- 6 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Smart-phone Medication Reminder Application to Promote Adherence to Oral Medications by Adolescents and Young Adults(AYA) With Cancer
- ClinicalTrials.gov ID
- NCT01618344
- Acronym / sponsor ID
- SCH-13929
- Conditions
- Neoplasms
- Keywords
- neoplasms, adolescent, young adult, medication adherence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Oncology Nursing Society
- Study start
- May 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 13 Jun 2012 (estimated)
- Results
- Posted 6 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To explore use of a smart-phone medication reminder application to promote adherence to oral medications by AYA with cancer.
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 29 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Primary care clinics for patients be treated for cancer.
Key inclusion criteria (5 listed)
- 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-
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yelena Wu, PhD principal investigator
Huntsman Cancer Institute
Lauri Linder, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.