Clinical trial NCT04194528: S1916 Digital Medicine Program for Pain Control in Cancer Patients
Official title: Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Metastatic Cancer
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: Proteus Digital Health, Inc.
First posted: 2019-12-11
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Feasibility Determined by Accrual, Adherence and Patient Retention.
timeFrame: adherence and retention - 6 weeks; accrual - 6 months
Secondary outcomes:
measure: Pain Levels and Pain Interference With Daily Activity
timeFrame: 2, 4, and 6 weeks.
measure: Opioid Medication Consumption
timeFrame: 6 weeks
measure: Unplanned Hospital and Emergency Department Visits
timeFrame: 6 weeks
measure: Frequency of Changes in Pain Management Regimen
timeFrame: 6 weeks
measure: Activity Levels
timeFrame: 6 weeks
measure: Patient Somatic Symptoms
timeFrame: baseline 2, 4, and 6 weeks.
measure: Patient Satisfaction With the Digital Medicine Program (DMP).
timeFrame: 6 weeks
measure: Provider Satisfaction With Digital Medicine Program (DMP)
timeFrame: 6 weeks
measure: ePRO Feasibility
timeFrame: 6 weeks
measure: Patient Psychological Distress
timeFrame: 2, 4, and 6 weeks
measure: Patient Global Quality of Life
timeFrame: 2, 4, and 6 weeks
Other outcomes:
Locations:
city: Decatur
country: United States
facility: Decatur Memorial Hospital
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center NCORP
state: Illinois
city: Billings
country: United States
facility: Montana Cancer Consortium
state: Montana
city: New York
country: United States
facility: Columbia University
state: New York
city: Greenville
country: United States
facility: PRISMA Health Upstate Cancer Institute
state: South Carolina
Study officials:
affiliation: SWOG Cancer Research Network
name: Dawn Hershman, M.D., M.S.
role: STUDY_CHAIR
References: