The Validation of a Novel Adherence Method for Oral Oncolytics

Cancer Clinical Trial

Official title:

The Validation of a Novel Adherence Method for Oral Oncolytics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03561272
• Other study ID #: UMCC 2015.030
• Secondary ID: HUM00098103
• Status: Completed
• Phase: N/A
• Start date: June 20, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: October 2019
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Smart Phone Application
Oral medication adherence phone application.
• POD
Pill dispensing system that dispenses the medication, controls dispensed dosage, and confirms dispensing to patient through wireless communication back to the control center.

Locations

Country	Name	City	State
United States	The University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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