Clinical trial NCT04088955: A Digimed Oncology PharmacoTherapy Registry
Official title: A Pragmatic, Non-Interventional Study of DigiMeds™ in Combination With Standard of Care for Treatment of Patients With Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colon Cancer
Breast Cancer
Rectal Cancer
Keywords: DigiMeds
Capecitabine
Standard of Care
Lead sponsor: Proteus Digital Health, Inc.
Sponsor class: INDUSTRY
First posted: 2019-09-13
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals diagnosed with colon, rectal, or breast cancer and diagnosed therapy with capecitabine.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Compare the duration of actual vs. intended treatment for cancer patients on capecitabine who are prescribed capecitabine with sensor.
timeFrame: Up to 6 months from the date of inclusion into study
Secondary outcomes:
Other outcomes:
Locations:
city: Rock Hill
country: United States
facility: Carolina Blood and Cancer Care
state: South Carolina
Study officials:
affiliation: Proteus Digital Health
name: Sinette Heys
role: STUDY_DIRECTOR
References: