S1916 Digital Medicine Program for Pain Control in Cancer Patients

• Status: Terminated
• Trial end date: 2020-09-16
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Southwest Oncology Group
• Collaborator: Proteus Digital Health, Inc.
• Treatments: Acetaminophen; Acetaminophen, hydrocodone drug combination; Oxycodone

Criteria

Inclusion Criteria:

• Diagnosis of metastatic cancer

• Patients must have a worst pain score of at least 3 (on a scale of 0-10) on the Brief Pain Inventory (BPI)* within 3 days prior to registration and be deemed by their physician to require initiation, continuation, or uptitration of opioid therapy with oxycodone/acetaminophen 5mg/325mg.

• Patients currently on oxycodone/acetaminophen are eligible as long as they are on the 5 mg/325 mg dose.

• Patients currently on another opiate, who have been prescribed or will be prescribed oxycodone/acetaminophen as an addition to their therapy are also eligible.

• Patients must be >/= 18 years of age

• Patients must complete the baseline PRO questionnaires prior to registration.

• Patients must be able to read English, as the ePRO questionnaires are in English and patient instructions on the Proteus Discover mobile application are in English.

• Patients must be willing to participate in electronic data collection and must have an iPhone, Android phone, or tablet with cellular connectivity in order to download the Patient Cloud and Proteus Discover mobile applications onto his/her device.

• Patients must have successfully downloaded the Proteus Discover App.

• Patients must not have a known allergy to adhesive tape, hydrogel or conductive gel, or hydrocolloid. (The adhesive strip for the Wearable Sensor Patch does not contain natural latex rubber).

• Patients of reproductive potential must have agreed to use an effective contraceptive method. All men are considered to be of reproductive potential unless they have had a vasectomy or orchiectomy.

Exclusion Criteria:

• Women must not be pregnant or nursing