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OpenTrials
Completed

NCT Number: NCT03561272

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Smart phone application

Other

Oral medication adherence 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.

Primary outcomes

  1. The change in the number of patients that report high adherence over time via smart phone application alone

    Time frame: 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).

  2. The change in the number of patients that report high adherence over time via smart phone application and POD

    Time frame: 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.

  3. The change in the number of patients that report high adherence over time via telephone/face-to-face visit (self-reported)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 19, 2018
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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