The Validation of a Novel Adherence Method for Oral Oncolytics

University of Michigan Rogel Cancer Center

Status: Completed

Conditions: Cancer

Treatments: Other: Smart Phone Application; Other: POD

Study type: Interventional

Funder types: Other

Identifiers

NCT03561272

UMCC 2015.030

HUM00098103 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Standard Patient Reported Adherence

No Intervention group

Description:

Adherence assessment via phone call or in person

Smart Phone Application

Active Comparator group

Description:

Adherence assessment via phone app

Treatment:

Other: Smart Phone Application

POD and Smart Phone Application

Experimental group

Description:

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

Treatment:

Other: Smart Phone Application

Other: POD