Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Breast Cancer
  • Colon Cancer
  • Rectal Cancer
Type
Observational
Design
Observational Model: OtherTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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. Pati...

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.

Tracking Information

NCT #
NCT04088955
Collaborators
Not Provided
Investigators
Study Director: Sinette Heys Proteus Digital Health