Conditions: Metastatic Cancer
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 2
Healthy volunteers: no

Brief summary:
This is a feasibility study to assess the use of a Digital Medicine Program (consisting of an FDA-approved ingestible sensor co-encapsulated with oxycodone/acetaminophen (5 mg/325 mg), a small wearable patch, and a mobile application) in cancer patients with metastatic disease experiencing uncontrolled pain.

Detailed description:
Given the high prevalence of cancer pain and issues with undertreatment and opioid misuse, focused efforts to improve monitoring of medication ingestion patterns are needed. This study will test the feasibility of using a Digital Medicine Program (consisting of an FDA-approved ingestible sensor co-encapsulated with oxycodone/acetaminophen (5 mg/325 mg), a small wearable patch, and a mobile application) in cancer patients with metastatic disease experiencing uncontrolled pain. Data collected from this study (such as information on patterns of DMP usage by patients and physicians and changes to medication dosage based on the reported symptoms) will inform the design of a randomized controlled trial of the DMP vs. usual care to control cancer pain and increase quality of life. If successful, this DMP could be a new way for physicians to evaluate patients' pain medication use patterns and titrate for adequate pain control while concurrently monitoring for adverse effects or abusive/addictive behavior. It will also promote improved communication between patients and their physicians and potentially address and ease some of patients' concerns and hesitancies regarding opioid medications.

Arms:
arm 1: The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks.

Interventions: intervention 1: Oxycodone/acetaminophen 5/325 mg intervention 2: Proteus digital medicine program
Intervention descriptions: intervention 1: The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks. intervention 2: The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks.

Protocol document:
Prot_SAP_ICF_001.pdf: 
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