Trial Outcomes & Findings for S1916 Digital Medicine Program for Pain Control in Cancer Patients (NCT NCT04194528)

NCT ID: NCT04194528

Last Updated: 2023-06-27

Results Overview

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).

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: adherence and retention - 6 weeks; accrual - 6 months
• Results posted on: 2023-06-27

Participant Flow

Participant milestones

Measure	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. 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 Study STARTED	2
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

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. 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 Study Adverse Event

1

Baseline Characteristics

S1916 Digital Medicine Program for Pain Control in Cancer Patients

Baseline characteristics by cohort

Measure	Oxycodone/Acetaminophen (5/325 mg) DMP n=2 Participants 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.
Age, Continuous	55.4 years n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=93 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	2 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	2 participants n=93 Participants

PRIMARY outcome

Timeframe: 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).

Outcome measures

Measure

Oxycodone/Acetaminophen (5/325 mg) DMP n=2 Participants 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.

Feasibility Determined by Accrual, Adherence and Patient Retention.

1 Participants

SECONDARY outcome

Timeframe: 2, 4, and 6 weeks.

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: 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.

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

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline 2, 4, and 6 weeks.

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 weeks

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2, 4, and 6 weeks

Population: 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.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2, 4, and 6 weeks

Population: 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.

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.

Outcome measures

Outcome data not reported

Adverse Events

Oxycodone/Acetaminophen (5/325 mg) DMP

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Oxycodone/Acetaminophen (5/325 mg) DMP n=2 participants at risk 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.
Gastrointestinal disorders Constipation	50.0% 1/2 • Number of events 1 • Adverse events are monitored and collected at the 2, 4, and 6-week follow up visits. 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.
Gastrointestinal disorders Nausea	50.0% 1/2 • Number of events 1 • Adverse events are monitored and collected at the 2, 4, and 6-week follow up visits. 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.
Gastrointestinal disorders Vomiting	50.0% 1/2 • Number of events 1 • Adverse events are monitored and collected at the 2, 4, and 6-week follow up visits. 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.

Additional Information

SWOG Statistician

SWOG Statistics and Data Management Center

Phone: 2066674623

Email: adarke@fredhutch.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60