The Validation of a Novel Adherence Method for Oral Oncolytics

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Smart Phone Application; Other: POD

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • The University of Michigan Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Patient Reported Adherence; Adherence assessment via phone call or in person
Active Comparator: Smart Phone Application; Adherence assessment via phone app	Other: Smart Phone Application; Oral medication adherence phone application.
Experimental: POD and Smart Phone Application; Adherence assessment via phone app partnered with an automated dispensing machine, a "Pod."	Other: Smart Phone Application; Oral medication adherence phone application.; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Michigan Rogel Cancer Center
• Investigators: Principal Investigator: Shawna Kraft, Pharm.D., BCOP, University of Michigan Rogel Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2017
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): October 31, 2018

Study Registration Dates

• First Submitted: March 2, 2018
• First Submitted That Met QC Criteria: June 15, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 2, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: UMCC 2015.030; HUM00098103 (Other Identifier: University of Michigan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No