S1916 Digital Medicine Program for Pain Control in Cancer Patients

• Sponsor: Southwest Oncology Group (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04194528
• Collaborator: Proteus Digital Health, Inc. (Industry)
• Enrollment: 2
• Locations: 5
• Arm: 1
• Actual Duration (Months): 11.1
• Patients Per Site: 0.4
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Cancer	Drug: Oxycodone/acetaminophen 5/325 mg; Device: Proteus digital medicine program	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
• Actual Study Start Date: Oct 15, 2019
• Actual Primary Completion Date: Sep 16, 2020
• Actual Study Completion Date: Sep 16, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: Oxycodone/acetaminophen (5/325 mg) DMP 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; 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.; Device: Proteus digital medicine program; 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.

Outcome Measures

Primary Outcome Measures

1. Feasibility Determined by Accrual, Adherence and Patient Retention. [adherence and retention - 6 weeks; accrual - 6 months]

   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).

Secondary Outcome Measures

1. Pain Levels and Pain Interference With Daily Activity [2, 4, and 6 weeks.]

   Pain levels are measured by average pain score and pain interference with daily activity score at 2, 4, and 6 weeks on the Brief Pain Inventory-Short Form (BPI-SF). Also, pain in the last 24 hours is measured daily using the worst pain item from the BPI-SF. Pain is rated on a scale of 0-10 with 10 signifying the worst symptoms.

2. Opioid Medication Consumption [6 weeks]

   Opioid medication consumption is assessed as the number of pills taken over the number of study pills prescribed.

3. Unplanned Hospital and Emergency Department Visits [6 weeks]

   Unplanned hospital and emergency department visits assessed as any reported unplanned visits because of pain between the date of registration and the 6-week follow-up timepoint.

4. Frequency of Changes in Pain Management Regimen [6 weeks]

   Frequency of changes in pain management regimen is measured as any change in the dosage, frequency, or the pain medication between baseline and 6-week follow-up.

5. Activity Levels [6 weeks]

   Activity levels are measured as active time and rest time in minutes and total daily step count.

6. Patient Somatic Symptoms [baseline 2, 4, and 6 weeks.]

   Patient somatic symptoms of opioid treatment will be measured using the Edmonton Symptom Assessment (revised version). Questions are rated on a scale of 1-10 with 10 being "worst" outcome.

7. Patient Satisfaction With the Digital Medicine Program (DMP). [6 weeks]

   Patient satisfaction will be assessed by survey that measures patient satisfaction on a scale of 1-5 with the higher score having the better outcome.

8. Provider Satisfaction With Digital Medicine Program (DMP) [6 weeks]

   Provider satisfaction will be assessed by survey that measures provider satisfaction on a scale of 1-5 with the higher score having the better outcome.

9. ePRO Feasibility [6 weeks]

   ePRO feasibility will be defined by the extent of missing data at each assessment time for those items or instruments required to be completed using the Patient Cloud ePRO app; assessing the patient experience of using the Patient Cloud ePRO app with a one-time questionnaire at the conclusion of the study.

10. Patient Psychological Distress [2, 4, and 6 weeks]

    Patient depression and anxiety will be measured using the Patient Health Questionnaire (PHQ-4). Questions are rated on a scale of 0-3 with higher score having the worst outcome.

11. Patient Global Quality of Life [2, 4, and 6 weeks]

    Patient quality of life (including anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, satisfaction with participation in social roles and activities and single pain intensity) will be measured using the PROMIS-29. Patients respond to questions by marking one response: very poor, poor, fair, good and very good.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Decatur Memorial Hospital	Decatur	Illinois	United States	62526
2	Carle Cancer Center NCORP	Urbana	Illinois	United States	61801
3	Montana Cancer Consortium	Billings	Montana	United States	59102
4	Columbia University	New York	New York	United States	10032
5	PRISMA Health Upstate Cancer Institute	Greenville	South Carolina	United States	29615

Sponsors and Collaborators

• Southwest Oncology Group
• Proteus Digital Health, Inc.

Investigators

• Study Chair: Dawn Hershman, M.D., M.S., SWOG Cancer Research Network

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Jun 11, 2019

More Information

Publications

None provided.

• Responsible Party: Southwest Oncology Group
• ClinicalTrials.gov Identifier: NCT04194528
• Other Study ID Numbers: S1916
• First Posted: Dec 11, 2019
• Last Update Posted: Dec 10, 2021
• Last Verified: Dec 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Neoplasm Metastasis; Acetaminophen; Acetaminophen, hydrocodone drug combination; Oxycodone

Study Results

Participant Flow

Arm/Group Title	Oxycodone/Acetaminophen (5/325 mg) DMP
Arm/Group Description	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: 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. Proteus digital medicine program: 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.
Period Title: Overall Study
STARTED	2
COMPLETED	1
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Oxycodone/Acetaminophen (5/325 mg) DMP
Arm/Group Description	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: 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. Proteus digital medicine program: 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.
Overall Participants	2
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	55.4
Sex: Female, Male (Count of Participants)
Female	1 50%
Male	1 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%
Not Hispanic or Latino	2 100%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	2 100%
More than one race	0 0%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	2 100%

Outcome Measures

1. Primary Outcome

Title	Feasibility Determined by Accrual, Adherence and Patient Retention.
Description	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).
Time Frame	adherence and retention - 6 weeks; accrual - 6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Oxycodone/Acetaminophen (5/325 mg) DMP
Arm/Group Description	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: 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. Proteus digital medicine program: 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.
Measure Participants	2
Count of Participants [Participants]	1 50%

2. Secondary Outcome

Title	Pain Levels and Pain Interference With Daily Activity
Description	Pain levels are measured by average pain score and pain interference with daily activity score at 2, 4, and 6 weeks on the Brief Pain Inventory-Short Form (BPI-SF). Also, pain in the last 24 hours is measured daily using the worst pain item from the BPI-SF. Pain is rated on a scale of 0-10 with 10 signifying the worst symptoms.
Time Frame	2, 4, and 6 weeks.

Outcome Measure Data

Analysis Population Description

Study only accrued 2 patients and had difficulty getting sites to participate in a trial with a controlled substance. Study was ultimately discontinued when the DMP software company went bankrupt and was sold. Due to the lack of patient data, only the primary objective was analyzed.

Arm/Group Title	Oxycodone/Acetaminophen (5/325 mg) DMP
Arm/Group Description	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: 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. Proteus digital medicine program: 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.
Measure Participants	0

3. Secondary Outcome

Title	Opioid Medication Consumption
Description	Opioid medication consumption is assessed as the number of pills taken over the number of study pills prescribed.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Study only accrued 2 patients and had difficulty getting sites to participate in a trial with a controlled substance. Study was ultimately discontinued when the DMP software company went bankrupt and was sold. Due to the lack of patient data, only the primary objective was analyzed.

Arm/Group Title	Oxycodone/Acetaminophen (5/325 mg) DMP
Arm/Group Description	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: 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. Proteus digital medicine program: 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.
Measure Participants	0

4. Secondary Outcome

Title	Unplanned Hospital and Emergency Department Visits
Description	Unplanned hospital and emergency department visits assessed as any reported unplanned visits because of pain between the date of registration and the 6-week follow-up timepoint.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Study only accrued 2 patients and had difficulty getting sites to participate in a trial with a controlled substance. Study was ultimately discontinued when the DMP software company went bankrupt and was sold. Due to the lack of patient data, only the primary objective was analyzed.

Arm/Group Title	Oxycodone/Acetaminophen (5/325 mg) DMP
Arm/Group Description	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: 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. Proteus digital medicine program: 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.
Measure Participants	0

5. Secondary Outcome

Title	Frequency of Changes in Pain Management Regimen
Description	Frequency of changes in pain management regimen is measured as any change in the dosage, frequency, or the pain medication between baseline and 6-week follow-up.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Study only accrued 2 patients and had difficulty getting sites to participate in a trial with a controlled substance. Study was ultimately discontinued when the DMP software company went bankrupt and was sold. Due to the lack of patient data, only the primary objective was analyzed.

Arm/Group Title	Oxycodone/Acetaminophen (5/325 mg) DMP
Arm/Group Description	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: 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. Proteus digital medicine program: 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.
Measure Participants	0

6. Secondary Outcome

Title	Activity Levels
Description	Activity levels are measured as active time and rest time in minutes and total daily step count.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Study only accrued 2 patients and had difficulty getting sites to participate in a trial with a controlled substance. Study was ultimately discontinued when the DMP software company went bankrupt and was sold. Due to the lack of patient data, only the primary objective was analyzed.

Arm/Group Title	Oxycodone/Acetaminophen (5/325 mg) DMP
Arm/Group Description	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: 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. Proteus digital medicine program: 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.
Measure Participants	0

7. Secondary Outcome

Title	Patient Somatic Symptoms
Description	Patient somatic symptoms of opioid treatment will be measured using the Edmonton Symptom Assessment (revised version). Questions are rated on a scale of 1-10 with 10 being "worst" outcome.
Time Frame	baseline 2, 4, and 6 weeks.

Outcome Measure Data

Analysis Population Description

Study only accrued 2 patients and had difficulty getting sites to participate in a trial with a controlled substance. Study was ultimately discontinued when the DMP software company went bankrupt and was sold. Due to the lack of patient data, only the primary objective was analyzed.

Arm/Group Title	Oxycodone/Acetaminophen (5/325 mg) DMP
Arm/Group Description	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: 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. Proteus digital medicine program: 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.
Measure Participants	0

8. Secondary Outcome

Title	Patient Satisfaction With the Digital Medicine Program (DMP).
Description	Patient satisfaction will be assessed by survey that measures patient satisfaction on a scale of 1-5 with the higher score having the better outcome.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Study only accrued 2 patients and had difficulty getting sites to participate in a trial with a controlled substance. Study was ultimately discontinued when the DMP software company went bankrupt and was sold. Due to the lack of patient data, only the primary objective was analyzed.

Arm/Group Title	Oxycodone/Acetaminophen (5/325 mg) DMP
Arm/Group Description	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: 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. Proteus digital medicine program: 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.
Measure Participants	0

9. Secondary Outcome

Title	Provider Satisfaction With Digital Medicine Program (DMP)
Description	Provider satisfaction will be assessed by survey that measures provider satisfaction on a scale of 1-5 with the higher score having the better outcome.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Study only accrued 2 patients and had difficulty getting sites to participate in a trial with a controlled substance. Study was ultimately discontinued when the DMP software company went bankrupt and was sold. Due to the lack of patient data, only the primary objective was analyzed.

Arm/Group Title	Oxycodone/Acetaminophen (5/325 mg) DMP
Arm/Group Description	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: 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. Proteus digital medicine program: 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.
Measure Participants	0

10. Secondary Outcome

Title	ePRO Feasibility
Description	ePRO feasibility will be defined by the extent of missing data at each assessment time for those items or instruments required to be completed using the Patient Cloud ePRO app; assessing the patient experience of using the Patient Cloud ePRO app with a one-time questionnaire at the conclusion of the study.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

Study only accrued 2 patients and had difficulty getting sites to participate in a trial with a controlled substance. Study was ultimately discontinued when the DMP software company went bankrupt and was sold. Due to the lack of patient data, only the primary objective was analyzed.

Arm/Group Title	Oxycodone/Acetaminophen (5/325 mg) DMP
Arm/Group Description	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: 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. Proteus digital medicine program: 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.
Measure Participants	0

11. Secondary Outcome

Title	Patient Psychological Distress
Description	Patient depression and anxiety will be measured using the Patient Health Questionnaire (PHQ-4). Questions are rated on a scale of 0-3 with higher score having the worst outcome.
Time Frame	2, 4, and 6 weeks

Outcome Measure Data

Analysis Population Description

Study only accrued 2 patients and had difficulty getting sites to participate in a trial with a controlled substance. Study was ultimately discontinued when the DMP software company went bankrupt and was sold. Due to the lack of patient data, only the primary objective was analyzed.

Arm/Group Title	Oxycodone/Acetaminophen (5/325 mg) DMP
Arm/Group Description	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: 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. Proteus digital medicine program: 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.
Measure Participants	0

12. Secondary Outcome

Title	Patient Global Quality of Life
Description	Patient quality of life (including anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, satisfaction with participation in social roles and activities and single pain intensity) will be measured using the PROMIS-29. Patients respond to questions by marking one response: very poor, poor, fair, good and very good.
Time Frame	2, 4, and 6 weeks

Outcome Measure Data

Analysis Population Description

Study only accrued 2 patients and had difficulty getting sites to participate in a trial with a controlled substance. Study was ultimately discontinued when the DMP software company went bankrupt and was sold. Due to the lack of patient data, only the primary objective was analyzed.

Arm/Group Title	Oxycodone/Acetaminophen (5/325 mg) DMP
Arm/Group Description	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: 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. Proteus digital medicine program: 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.
Measure Participants	0

Adverse Events

Time Frame	Adverse events are monitored and collected at the 2, 4, and 6-week follow up visits.
Adverse Event Reporting Description	Patients will complete the S1916 Opioid Adverse Event Survey (See Section 14.4) at the 2, 4, and 6-week follow-up visits to report the frequency with which they experience several potential adverse effects. Sites will collect side effect data at the same interval on the S1916 Adverse Events form and code using CTCAE 5.0. The rare adverse effects associated with the Digital Medicine Program (ingestible sensor and patch) will be collected on S1916 Follow-Up form.
Arm/Group Title	Oxycodone/Acetaminophen (5/325 mg) DMP
Arm/Group Description	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: 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. Proteus digital medicine program: 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.
All Cause Mortality
	Oxycodone/Acetaminophen (5/325 mg) DMP
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Serious Adverse Events
	Oxycodone/Acetaminophen (5/325 mg) DMP
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Oxycodone/Acetaminophen (5/325 mg) DMP
	Affected / at Risk (%)	# Events
Total	2/2 (100%)
Gastrointestinal disorders
Constipation	1/2 (50%)	1
Nausea	1/2 (50%)	1
Vomiting	1/2 (50%)	1

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.