Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Oncology Nursing Society | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To explore use of a smart-phone medication reminder application to promote adherence to oral medications by AYA with cancer.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | ongoing study weeks 5-12 |
Not provided
Not provided
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.
Not provided
Not provided
Primary care clinics for patients be treated for cancer.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yelena Wu, PhD | Huntsman Cancer Institute | Principal Investigator |
| Lauri Linder, PhD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Smart-phone Medication Reminder Application | All participants were provided with the medication reminder application, and were instructed on how to program the application based on their individual medication dosing schedules. At the scheduled times, the application prompted participants to take their medications. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants | All participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | ongoing study weeks 5-12 |
|
|
Through study completion, an average of 3 months per participant.
Any adverse events would have been reported to the University of Utah Institutional Review Board via a report form.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants | All participants |
Not provided
Not provided
Small pilot trial (single group). Pre-post measurements only.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Yelena Wu | Hunstman Cancer Institute | 801-213-5653 | yelena.wu@utah.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2014 | Oct 5, 2017 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 0 |
| 32 |
| 0 |
| 32 |
Not provided
Not provided
Not provided
| D001519 | Behavior |