S1916 Digital Medicine Program for Pain Control in Cancer Patients

NCT04194528 | Terminated Results DMC FDA Device

• 1 other identifier: S1916
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 5

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.

Conditions

Metastatic Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility Determined by Accrual, Adherence and Patient Retention.

  Feasibility will be determined by accrual (as confirmed by registration to the trial), adherence and patient retention (as measured and relayed by the wearable patch/sensor).

  adherence and retention - 6 weeks; accrual - 6 months

Secondary Outcomes (11)

• Pain Levels and Pain Interference With Daily Activity

  2, 4, and 6 weeks.

• Opioid Medication Consumption

  6 weeks

• Unplanned Hospital and Emergency Department Visits

  6 weeks

• Frequency of Changes in Pain Management Regimen

  6 weeks

• Activity Levels

  6 weeks

Study Arms (1)

Oxycodone/acetaminophen (5/325 mg) DMP

EXPERIMENTAL

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.

Drug: Oxycodone/acetaminophen 5/325 mg; Device: Proteus digital medicine program

Interventions

Oxycodone/acetaminophen 5/325 mg DRUG

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.

Oxycodone/acetaminophen (5/325 mg) DMP

Proteus digital medicine program DEVICE

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.

Oxycodone/acetaminophen (5/325 mg) DMP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• Proteus Digital Health, Inc.: collaborator

Study Sites (5)

Decatur Memorial Hospital

Decatur, Illinois, 62526, United States

Location

Carle Cancer Center NCORP

Urbana, Illinois, 61801, United States

Location

Montana Cancer Consortium

Billings, Montana, 59102, United States

Location

Columbia University

New York, New York, 10032, United States

Location

PRISMA Health Upstate Cancer Institute

Greenville, South Carolina, 29615, United States

Location

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Oxycodone; Acetaminophen

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Only 2 participants were accrued due to COVID-19 limiting enrollment in sites and the extreme difficulty in getting sites to participate in the trial due to the use of a controlled substance as state regulations varied. The study was discontinued when the company providing the DMP and associated software went bankrupt and was acquired by a company that had no interest in continuing the trial. Due to a lack of patient data, we did not analyze any of objectives other than telemedicine feasibility.

Results Point of Contact

• Title: SWOG Statistician
• Organization: SWOG Statistics and Data Management Center

adarke@fredhutch.org

2066674623

Study Officials

• Dawn Hershman, M.D., M.S.

  SWOG Cancer Research Network

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2019
• First Posted: December 11, 2019
• Study Start: January 22, 2020
• Primary Completion: September 16, 2020
• Study Completion: September 16, 2020
• Last Updated: June 27, 2023
• Results First Posted: December 10, 2021

Record last verified: 2023-06

Locations

US (5)