The Validation of a Novel Adherence Method for Oral Oncolytics

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Smart Phone Application; Other: POD

• Registration Number: NCT03561272
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-20
• Study First Submitted: 2018-03-02
• Study First Submitted QC: 2018-06-15
• Study First Posted: 2018-06-19
• Primary Completion: 2018-10-31
• Study Completion: 2018-10-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-02
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smart Phone Application	Smart Phone Application	Adherence assessment via phone app
POD and Smart Phone Application	POD	Adherence assessment via phone app partnered with an automated dispensing machine, a "Pod."
POD and Smart Phone Application	Smart Phone Application	Adherence assessment via phone app partnered with an automated dispensing machine, a "Pod."

Primary Outcome Measures

Name	Time	Method
The change in the number of patients that report high adherence over time via smart phone application alone	0, 4, 8 and 12 weeks	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).
The change in the number of patients that report high adherence over time via smart phone application and POD	0, 4, 8 and 12 weeks	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.
The change in the number of patients that report high adherence over time via telephone/face-to-face visit (self-reported)	0, 4, 8 and 12 weeks	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).

Trial Locations

Locations (1)

The University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States