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Metastatic CancerNCT04194528

S1916 Digital Medicine Program for Pain Control in Cancer Patients

A study testing Oxycodone/acetaminophen 5/325 mg and Proteus digital medicine program in people with Metastatic Cancer, run by SWOG Cancer Research Network at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Cancer
What is being tested?
Oxycodone/acetaminophen 5/325 mg and Proteus digital medicine program
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
5 sitesUnited States
Study dates
22 Jan 2020to 16 Sep 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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.

Who cannot join

  • Women must not be pregnant or nursing

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Montana Cancer Consortium

    Billings, Montana, 59102

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • PRISMA Health Upstate Cancer Institute

    Greenville, South Carolina, 29615

  • Columbia University

    New York, New York, 10032

  • Carle Cancer Center NCORP

    Urbana, Illinois, 61801

Other trials in United States

About this study

Official title: Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients

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.

Read the 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.

Being tested
Oxycodone/acetaminophen 5/325 mg, Proteus digital medicine program
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oxycodone/acetaminophen 5/325 mgDrug

    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 programDevice

    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.

Study groups in NCT04194528
Study groupRoleWhat they receive
Oxycodone/acetaminophen (5/325 mg) DMPExperimentalThe 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.
Receives: Drug: Oxycodone/acetaminophen 5/325 mg; Device: Proteus digital medicine program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: adherence and retention - 6 weeks; accrual - 6 months

Secondary outcomes (11)

  1. 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.

    Measured: 2, 4, and 6 weeks.

  2. Opioid Medication Consumption

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

    Measured: 6 weeks

  3. 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.

    Measured: 6 weeks

  4. 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.

    Measured: 6 weeks

  5. Activity Levels

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

    Measured: 6 weeks

  6. 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.

    Measured: baseline 2, 4, and 6 weeks.

  7. 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.

    Measured: 6 weeks

  8. 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.

    Measured: 6 weeks

  9. 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.

    Measured: 6 weeks

  10. 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.

    Measured: 2, 4, and 6 weeks

  11. 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.

    Measured: 2, 4, and 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2019
  2. Study start22 Jan 2020
  3. Primary completion16 Sep 2020
  4. Study completion16 Sep 2020

Why it stopped: Study sponsor withdrew support.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04194528
Sponsor's protocol ID
S1916
Status last verified
Jun 2023
First submitted
6 Dec 2019
Last updated
27 Jun 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Oxycodone/acetaminophen 5/325 mg and Proteus digital medicine program in people with Metastatic Cancer, run by SWOG Cancer Research Network at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility Determined by Accrual, Adherence and Patient Retention. (time frame: adherence and retention - 6 weeks; accrual - 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04194528.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2023.

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