A Digimed Oncology PharmacoTherapy Registry

Breast Cancer Clinical Trial

— ADOPTR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04088955
• Other study ID #: PRO 1676
• Status: Active, not recruiting
• Start date: September 6, 2019
• Est. completion date: March 2022

Study information

• Verified date: September 2019
• Source: Proteus Digital Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. completion date: March 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Colon Cancer
• Colonic Neoplasms
• Rectal Cancer
• Rectal Neoplasms

Intervention

Other:
• DigiMeds
Digitized Capecitabine

Locations

Country	Name	City	State
United States	Carolina Blood and Cancer Care	Rock Hill	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Proteus Digital Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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