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S1916 Digital Medicine Program for Pain Control in Cancer Patients

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ClinicalTrials.gov Identifier: NCT04194528
Recruitment Status : Terminated (Study sponsor withdrew support.)
First Posted : December 11, 2019
Last Update Posted : January 13, 2021
Sponsor:
Collaborator:
Proteus Digital Health, Inc.
Information provided by (Responsible Party):
Southwest Oncology Group

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : October 15, 2019
Actual Primary Completion Date : September 16, 2020
Actual Study Completion Date : September 16, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Feasibility determined by accrual, adherence and patient retention. [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 6 weeks ]
    Activity levels are measured as active time and rest time in minutes and total daily step count.

  6. Patient somatic symptoms [ Time Frame: 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). [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04194528


Locations
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United States, Illinois
Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Carle Cancer Center NCORP
Urbana, Illinois, United States, 61801
United States, Montana
Montana Cancer Consortium
Billings, Montana, United States, 59102
United States, New York
Columbia University
New York, New York, United States, 10032
United States, South Carolina
PRISMA Health Upstate Cancer Institute
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
Southwest Oncology Group
Proteus Digital Health, Inc.
Investigators
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Study Chair: Dawn Hershman, M.D., M.S. SWOG Cancer Research Network
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Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT04194528    
Other Study ID Numbers: S1916
First Posted: December 11, 2019    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: December 2020

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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:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes
Acetaminophen
Acetaminophen, hydrocodone drug combination
Oxycodone
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Anti-Inflammatory Agents, Non-Steroidal
Anti-Inflammatory Agents
Antirheumatic Agents