A Digimed Oncology PharmacoTherapy Registry | NCT04088955

Studies
A Digimed Oncology PharmacoTherapy Registry

NCT04088955

Sponsor

Proteus Digital Health, Inc.

Status

Unknown status

Last Update Posted

Mar 11, 2020Actual

Enrollment

500Estimated

Phase

Not provided

Conditions

Colon Cancer
Breast Cancer
Rectal Cancer

Interventions

DigiMeds

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 6, 2019Actual

Primary Completion Date

Sep 2021Estimated

Completion Date

Mar 2022Estimated

First Submitted Date

Sep 10, 2019

First Submission Date that Met QC Criteria

Sep 11, 2019

First Posted Date

Sep 13, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2020

Last Update Posted Date

Mar 11, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DigiMeds	Other	Digitized Capecitabine

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sinette Heys	Proteus Digital Health	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Carolina Blood and Cancer Care		Rock Hill	South Carolina	29732	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms
D001943	Breast Neoplasms
D012004	Rectal Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

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Browse Branches

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