The Validation of a Novel Adherence Method for Oral Oncolytics

Study Overview
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Brief Summary
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The long-term goal of this research is to apply technologic approaches to improve the use of oral oncolytics. The objective of this study is to assess patient adherence to oral oncolytics and to validate a currently available smart phone application (iRxReminder) partnered with an automated dispensing device, a Pod, in affecting patient adherence. The rationale for this study is that medication adherence to oncolytics varies and strategies are needed to improve it.

Official Title
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The Validation of a Novel Adherence Method for Oral Oncolytics

Conditions
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Cancer

Intervention / Treatment
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* Other: Smart Phone Application
* Other: POD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Must be > 18 years of age Must have a smart phone Must be able to have their oral oncolytic filled at the University of Michigan Comprehensive Cancer Center pharmacy and be newly prescribed Capecitabine (Xeloda). Exclusion Criteria: Patients who do not have a smart phone Patients who have a serious mental illness or cognitive impairment, e.g., psychosis or dementia. Patients who do not speak English Patients who cannot fill their oral oncolytic prescription at the University of Michigan Comprehensive Cancer Center Pharmacy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Patient Reported Adherence<br>Adherence assessment via phone call or in person | |
| Active Comparator: Smart Phone Application<br>Adherence assessment via phone app | Other: Smart Phone Application<br>* Oral medication adherence phone application.<br>|
| Experimental: POD and Smart Phone Application<br>Adherence assessment via phone app partnered with an automated dispensing machine, a Pod. | Other: Smart Phone Application<br>* Oral medication adherence phone application.<br>Other: POD<br>* Pill dispensing system that dispenses the medication, controls dispensed dosage, and confirms dispensing to patient through wireless communication back to the control center.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the number of patients that report high adherence over time via smart phone application alone | Adherence will be assessed via smart phone application at baseline, 4, 8 and 12 weeks. Adherence reported via the phone application will be done using an adherence question assessment.This assessment is ordinal in nature and asks the patient to rate their adherence on a scale (poor, fair, good, very good, excellent). | 0, 4, 8 and 12 weeks | 
| The change in the number of patients that report high adherence over time via smart phone application and POD | Adherence will be assessed via smart phone application + POD at baseline, 4, 8 and 12 weeks. Adherence reported via the phone application will be done using an adherence question assessment.This assessment is ordinal in nature and asks the patient to rate their adherence on a scale (poor, fair, good, very good, excellent). For the Pod there will be continuous adherence assessed via the pod each time the patient administers or does not administer a scheduled dose. This will be figured into the overall adherence rating. | 0, 4, 8 and 12 weeks | 
| The change in the number of patients that report high adherence over time via telephone/face-to-face visit (self-reported) | Adherence will be assessed via telephone/face-to-face visit (self-reported) at baseline, 4, 8 and 12 weeks. Self-reported adherence will be done using an adherence question assessment.This assessment is ordinal in nature and asks the patient to rate their adherence on a scale (poor, fair, good, very good, excellent). | 0, 4, 8 and 12 weeks |