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S1916 Digital Medicine Program for Pain Control in Cancer Patients

Primary Purpose

Metastatic Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Oxycodone/acetaminophen 5/325 mg
Proteus digital medicine program
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metastatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Decatur Memorial Hospital
  • Carle Cancer Center NCORP
  • Montana Cancer Consortium
  • Columbia University
  • PRISMA Health Upstate Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Oxycodone/acetaminophen (5/325 mg) DMP

Arm 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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Opioid Medication Consumption
Opioid medication consumption is assessed as the number of pills taken over the number of study pills prescribed.
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.
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.
Activity Levels
Activity levels are measured as active time and rest time in minutes and total daily step count.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
December 6, 2019
Last Updated
June 7, 2023
Sponsor
SWOG Cancer Research Network
Collaborators
Proteus Digital Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04194528
Brief Title
S1916 Digital Medicine Program for Pain Control in Cancer Patients
Official Title
Feasibility of a Digital Medicine Program in Optimizing Opioid Pain Control in Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Terminated
Why Stopped
Study sponsor withdrew support.
Study Start Date
January 22, 2020 (Actual)
Primary Completion Date
September 16, 2020 (Actual)
Study Completion Date
September 16, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SWOG Cancer Research Network
Collaborators
Proteus Digital Health, Inc.

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxycodone/acetaminophen (5/325 mg) DMP
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Oxycodone/acetaminophen 5/325 mg
Intervention 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.
Intervention Type
Device
Intervention Name(s)
Proteus digital medicine program
Intervention 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.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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.
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
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
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
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
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.
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
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
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Hershman, M.D., M.S.
Organizational Affiliation
SWOG Cancer Research Network
Official's Role
Study Chair
Facility Information:
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Carle Cancer Center NCORP
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
PRISMA Health Upstate Cancer Institute
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States

12. IPD Sharing Statement

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S1916 Digital Medicine Program for Pain Control in Cancer Patients

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