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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04088955|
Recruitment Status : Active, not recruiting
First Posted : September 13, 2019
Last Update Posted : March 11, 2020
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|
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|
|Estimated Enrollment :||500 participants|
|Official Title:||A Pragmatic, Non-Interventional Study of DigiMeds™ in Combination With Standard of Care for Treatment of Patients With Cancer|
|Actual Study Start Date :||September 6, 2019|
|Estimated Primary Completion Date :||September 2021|
|Estimated Study Completion Date :||March 2022|
- Other: DigiMeds
- 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
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
|United States, South Carolina|
|Carolina Blood and Cancer Care|
|Rock Hill, South Carolina, United States, 29732|
|Study Director:||Sinette Heys||Proteus Digital Health|