A Digimed Oncology PharmacoTherapy Registry (ADOPTR)

March 9, 2020 updated by: Proteus Digital Health, Inc.

A Pragmatic, Non-Interventional Study of DigiMeds™ in Combination With Standard of Care for Treatment of Patients With Cancer

DigiMeds™ are medications with FDA-approved ingestible sensors (IS), a wearable sensor patch (patch), and a mobile app, which records time-stamped medication type and dose alongside biometric activity.

The aim of this registry is to collect and analyze data on the use of DigiMeds™ and a digital feedback system on medication adherence, patient-provider communication, and data-driven optimization of therapy for cancer patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients will be prescribed the DMP and DigiMeds™ (capecitabine or supportive medications) by their healthcare provider. The pharmacy will co-encapsulate the prescribed medication with a sensor.

The actual doses of DigiMeds™ will be based on standard of care as prescribed by treating physician. Patients will be instructed in the use of the DigiMeds™ and the DMP based on standard of care plus use of the DMP system.

Every effort should be made to take the DigiMeds™ as prescribed.

Patients in this study will be given the option to use their personal smartphone or will be provided a provisioned iPad to use for the duration of the study. Each patient will receive a Starter Kit comprised of two wearable sensor pods, adhesive strips, and instructions. Additionally, some kits may contain the provisional iPad Mini and charger for those without an approved smart device. Should a device malfunction occur, such as a broken pod, the patient can replace it with their spare pod. Broken pods should be returned to Proteus as soon as possible and all pods must be returned to the clinic upon completion of the study.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Rock Hill, South Carolina, United States, 29732
        • Carolina Blood and Cancer Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals diagnosed with colon, rectal, or breast cancer and diagnosed therapy with capecitabine.

Description

Inclusion Criteria:

  • Age ≥ 18
  • Prescribed treatment with DigiMeds™
  • Have an Android or iOS-enabled device (e.g., iPhone, iPad, Samsung) or be willing to use a Proteus issued iOS device
  • Signed consent form

Exclusion Criteria:

  • Receiving palliative or hospice care services (i.e., proxy for <12 months life expectancy)
  • Not proficient in the English language
  • Have impaired cognitive ability
  • For women: current pregnancy
  • Have skin sensitivity to adhesives or active/chronic dermatitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the duration of actual vs. intended treatment for cancer patients on capecitabine who are prescribed capecitabine with sensor.
Time Frame: Up to 6 months from the date of inclusion into study
Determine how long patients can stay on treatment when using DigiMeds
Up to 6 months from the date of inclusion into study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Proteus Digital Health, Inc.

Investigators

  • Study Director: Sinette Heys, Proteus Digital Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 6, 2019

Primary Completion (Anticipated)

September 1, 2021

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

September 10, 2019

First Submitted That Met QC Criteria

September 11, 2019

First Posted (Actual)

September 13, 2019

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRO 1676

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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