A Digimed Oncology PharmacoTherapy Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Colon Cancer, Breast Cancer, Rectal Cancer

Intervention / Treatment
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* Other: DigiMeds


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: DigiMeds|Digitized Capecitabine|

What is the study measuring?
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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. | Determine how long patients can stay on treatment when using DigiMeds | Up to 6 months from the date of inclusion into study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DigiMeds, Capecitabine, Standard of Care