S1916 Digital Medicine Program for Pain Control in Cancer Patients

Stopped early · Not applicable

Conditions studied: Metastatic Cancer

In brief

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.

Key facts

Study ID

NCT04194528

Run by

SWOG Cancer Research Network

People needed

2

Starts

2020-01-22

Expected to finish

2020-09-16

Last updated by the study team

2023-06-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Women must not be pregnant or nursing

Where it is running

• Decatur Memorial Hospital — Decatur, Illinois, United States
• Carle Cancer Center NCORP — Urbana, Illinois, United States
• Montana Cancer Consortium — Billings, Montana, United States
• Columbia University — New York, New York, United States
• PRISMA Health Upstate Cancer Institute — Greenville, South Carolina, United States

Full record on ClinicalTrials.gov

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