A Digimed Oncology PharmacoTherapy Registry

NCT04088955 | Unknown

• 1 other identifier: PRO 1676
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer; Breast Cancer; Rectal Cancer

Keywords

DigiMeds; Capecitabine; Standard of Care

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

DigiMeds OTHER

Digitized Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Proteus Digital Health, Inc.: lead

Study Sites (1)

Carolina Blood and Cancer Care

Rock Hill, South Carolina, 29732, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Breast Neoplasms; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Rectal Diseases

Study Officials

• Sinette Heys

  Proteus Digital Health

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2019
• First Posted: September 13, 2019
• Study Start: September 6, 2019
• Primary Completion: September 1, 2021
• Study Completion: March 1, 2022
• Last Updated: March 11, 2020

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)