The Validation of a Novel Adherence Method for Oral Oncolytics

NCT03561272 | Completed DMC

• 2 other identifiers: UMCC 2015.030HUM00098103
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Standard Patient Reported Adherence

NO INTERVENTION

Adherence assessment via phone call or in person

Smart Phone Application

ACTIVE COMPARATOR

Adherence assessment via phone app

Other: Smart Phone Application

POD and Smart Phone Application

EXPERIMENTAL

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

Other: Smart Phone Application; Other: POD

Interventions

Smart Phone Application OTHER

Oral medication adherence phone application.

POD and Smart Phone Application; Smart Phone Application

POD OTHER

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

POD and Smart Phone Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan Rogel Cancer Center: lead

Study Sites (1)

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Shawna Kraft, Pharm.D., BCOP

  University of Michigan Rogel Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2018
• First Posted: June 19, 2018
• Study Start: June 20, 2017
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: October 4, 2019

Record last verified: 2019-10

Locations

US (1)