Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Digimed Oncology PharmacoTherapy Registry (ADOPTR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04088955
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : September 13, 2019
Sponsor:
Information provided by (Responsible Party):
Proteus Digital Health, Inc.

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.


Condition or disease Intervention/treatment
Colon Cancer Breast Cancer Rectal Cancer Other: DigiMeds

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: A Pragmatic, Non-Interventional Study of DigiMeds™ in Combination With Standard of Care for Treatment of Patients With Cancer
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : March 2022

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: DigiMeds
    Digitized Capecitabine


Primary Outcome Measures :
  1. Compare the duration of actual vs. intended treatment for cancer patients on capecitabine who are prescribed capecitabine with sensor. [ Time Frame: Up to 6 months from the date of inclusion into study ]
    Determine how long patients can stay on treatment when using DigiMeds



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Individuals diagnosed with colon, rectal, or breast cancer and diagnosed therapy with capecitabine.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088955


Contacts
Layout table for location contacts
Contact: Supriya Yagnik 650-632-4031 syagnik@proteus.com

Locations
Layout table for location information
United States, South Carolina
Carolina Blood and Cancer Care Recruiting
Rock Hill, South Carolina, United States, 29732
Contact: Dhwani Mehta    803-329-7772    dmehta@cbcca.net   
Principal Investigator: Niyati Nathwani, MD         
Sponsors and Collaborators
Proteus Digital Health, Inc.
Investigators
Layout table for investigator information
Study Director: Sinette Heys Proteus Digital Health

Layout table for additonal information
Responsible Party: Proteus Digital Health, Inc.
ClinicalTrials.gov Identifier: NCT04088955     History of Changes
Other Study ID Numbers: PRO 1676
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: September 13, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Proteus Digital Health, Inc.:
DigiMeds
Capecitabine
Standard of Care
Additional relevant MeSH terms:
Layout table for MeSH terms
Rectal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Colonic Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents