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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.

Tracking Information
First Submitted Date September 10, 2019
First Posted Date September 13, 2019
Last Update Posted Date September 13, 2019
Estimated Study Start Date September 2019
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 11, 2019)
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
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Individuals diagnosed with colon, rectal, or breast cancer and diagnosed therapy with capecitabine.
Condition
  • Colon Cancer
  • Breast Cancer
  • Rectal Cancer
Intervention Other: DigiMeds
Digitized Capecitabine
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 11, 2019)
500
Original Estimated Enrollment Same as current
Estimated Study Completion Date March 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Supriya Yagnik 650-632-4031 syagnik@proteus.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04088955
Other Study ID Numbers PRO 1676
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Proteus Digital Health, Inc.
Study Sponsor Proteus Digital Health, Inc.
Collaborators Not Provided
Investigators
Study Director: Sinette Heys Proteus Digital Health
PRS Account Proteus Digital Health, Inc.
Verification Date September 2019