The Validation of a Novel Adherence Method for Oral Oncolytics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-20

Study Completion Date

2018-10-31

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.

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Standard Patient Reported Adherence

Adherence assessment via phone call or in person

Group Type NO_INTERVENTION

No interventions assigned to this group

Smart Phone Application

Adherence assessment via phone app

Group Type ACTIVE_COMPARATOR

Smart Phone Application

Intervention Type OTHER

Oral medication adherence phone application.

POD and Smart Phone Application

Adherence assessment via phone app partnered with an automated dispensing machine, a "Pod."

Group Type EXPERIMENTAL

Smart Phone Application

Intervention Type OTHER

Oral medication adherence phone application.

POD

Intervention Type OTHER

Pill dispensing system that dispenses the medication, controls dispensed dosage, and confirms dispensing to patient through wireless communication back to the control center.

Interventions

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Smart Phone Application

Oral medication adherence phone application.

Intervention Type OTHER

POD

Pill dispensing system that dispenses the medication, controls dispensed dosage, and confirms dispensing to patient through wireless communication back to the control center.

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No