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Study sponsor withdrew support.
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| Name | Class |
|---|---|
| Proteus Digital Health, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Levels and Pain Interference With Daily Activity | 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, 4, and 6 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dawn Hershman, M.D., M.S. | SWOG Cancer Research Network | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Decatur Memorial Hospital | Decatur | Illinois | 62526 | United States | ||
| Carle Cancer Center NCORP |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Posted | Count of Participants | Participants | adherence and retention - 6 weeks; accrual - 6 months |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SWOG Statistician | SWOG Statistics and Data Management Center | 2066674623 | adarke@fredhutch.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 11, 2019 | Dec 8, 2021 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010098 | Oxycodone |
| D000082 | Acetaminophen |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
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|
| 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. |
|
| Opioid Medication Consumption | Opioid medication consumption is assessed as the number of pills taken over the number of study pills prescribed. | 6 weeks |
| Unplanned Hospital and Emergency Department Visits | 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. | 6 weeks |
| Frequency of Changes in Pain Management Regimen | 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. | 6 weeks |
| Activity Levels | Activity levels are measured as active time and rest time in minutes and total daily step count. | 6 weeks |
| Patient Somatic Symptoms | 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. | baseline 2, 4, and 6 weeks. |
| Patient Satisfaction With the Digital Medicine Program (DMP). | 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. | 6 weeks |
| Provider Satisfaction With Digital Medicine Program (DMP) | 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. | 6 weeks |
| ePRO Feasibility | 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. | 6 weeks |
| Patient Psychological Distress | 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. | 2, 4, and 6 weeks |
| Patient Global Quality of Life | 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. | 2, 4, and 6 weeks |
| Urbana |
| Illinois |
| 61801 |
| United States |
| Montana Cancer Consortium | Billings | Montana | 59102 | United States |
| Columbia University | New York | New York | 10032 | United States |
| PRISMA Health Upstate Cancer Institute | Greenville | South Carolina | 29615 | United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Pain Levels and Pain Interference With Daily Activity | 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. | 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. | Posted | 2, 4, and 6 weeks. |
|
|
| Secondary | Opioid Medication Consumption | Opioid medication consumption is assessed as the number of pills taken over the number of study pills prescribed. | 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. | Posted | 6 weeks |
|
|
| Secondary | Unplanned Hospital and Emergency Department Visits | 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. | 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. | Posted | 6 weeks |
|
|
| Secondary | Frequency of Changes in Pain Management Regimen | 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. | 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. | Posted | 6 weeks |
|
|
| Secondary | Activity Levels | Activity levels are measured as active time and rest time in minutes and total daily step count. | 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. | Posted | 6 weeks |
|
|
| Secondary | Patient Somatic Symptoms | 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. | 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. | Posted | baseline 2, 4, and 6 weeks. |
|
|
| Secondary | Patient Satisfaction With the Digital Medicine Program (DMP). | 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. | 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. | Posted | 6 weeks |
|
|
| Secondary | Provider Satisfaction With Digital Medicine Program (DMP) | 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. | 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. | Posted | 6 weeks |
|
|
| Secondary | ePRO Feasibility | 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. | 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. | Posted | 6 weeks |
|
|
| Secondary | Patient Psychological Distress | 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. | 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. | Posted | 2, 4, and 6 weeks |
|
|
| Secondary | Patient Global Quality of Life | 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. | 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. | Posted | 2, 4, and 6 weeks |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 2 |
| 2 |
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
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| D000470 |
| Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |