Breast Cancer Clinical Trial

A Digimed Oncology PharmacoTherapy Registry

Summary

DigiMedsâ„¢ 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 DigiMedsâ„¢ and a digital feedback system on medication adherence, patient-provider communication, and data-driven optimization of therapy for cancer patients.

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Full Description

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

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

Every effort should be made to take the DigiMedsâ„¢ 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age ≥ 18
Prescribed treatment with DigiMedsâ„¢
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 is for people with:

Breast Cancer

Estimated Enrollment:

500

Study ID:

NCT04088955

Recruitment Status:

Unknown status

Sponsor:

Proteus Digital Health, Inc.

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There is 1 Location for this study

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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

500

Study ID:

NCT04088955

Recruitment Status:

Unknown status

Sponsor:


Proteus Digital Health, Inc.

How clear is this clinincal trial information?

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