Breast Cancer, Opioid Use
Conditions
Brief summary
This research study will evaluate the use of, and participants experience with, a new device called Addinex that safely stores and dispenses opioid medication. The purpose of this study is to evaluate the use of the Addinex device in cancer patients undergoing cancer-related surgery that require pain control with opioids after the surgery. Participants will be asked to answer questions about their medical history and background, fill out questionnaires, use a mobile application associated with the device, and undergo a phone interview one month after stopping use of the device. This study aims to find out how participants like using the Addinex device as opposed to a traditional pill bottle. Results of this study will help determine if the Addinex device could be useful to patients in the future after surgeries, as opposed to typical pill bottles.
Detailed description
This is a non-randomized pilot study to test the use of the Addinex system among participants receiving opioids following surgery. The Addinex system is designed to dispense opioid medication to participants on a provider-determined schedule, to track participant use of the device, and to allow for return and disposal of unused opioids. This study will determine the feasibility of using Addinex for these purposes.
Interventions
DEVICEAddinex Device (ADX-27)
The device operates without the use of any electronics, wireless or firmware requirements. This is achieved through its mechanical system which uses a different randomized "passcode" for each dose that is loaded into a circular drum inside the device. The "passcodes" are provided by an online server through either a mobile app, web app, text service or call in service. The online server provides "passcodes" on a request basis, while following instructions set by the treating physicians.
Sponsors
Columbia University
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
To assess the impact of a password-protected pill-dispensing system, Addinex, on unused opioid disposal, opioid use, and opioid refills rates after cancer-related surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Adult patients (age greater than or equal to 18 years) * Planned for major cancer-related surgery and expected to receive a postoperative opioid prescription * Must speak English or Spanish * Must have access to a smartphone or an alternative smart device (e.g., iPhone, Android phone, iPad, Surface, etc.). * Co-enrollment in trials involving pharmacologic therapy is allowed
Exclusion criteria
* Patients who are taking opioids daily prior to the surgical procedure * Patients unable to physically utilize the device * Patients unable to self-administer medications * Patients uncomfortable with using iPhone or iPad-based technology
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Device Return | 12 weeks | The rate of device return will be determined by an online logging of returned devices by a medical waste disposal company. |
| Rate of Unused Pill Disposal | 12 weeks | The number of unused pills disposed will be deduced based on the number of passwords requested from returned devices. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Pill Consumption | 12 weeks | Median opioid consumption will be deduced from the number of password requests. Number, date and time of participant password requests are logged on an online database maintained by Addinex. |
| Duration of Opioid Use | 12 weeks | Opioid Use Duration will be measured in days and deduced from the dates of password requests. Number, date and time of participant password requests are logged on an online database maintained by Addinex. |
| Opioid Refill Rate | 12 weeks | Opioid refill rates will be determined through review of electronic medical records and state prescription monitoring programs. |
| Change in Brief Pain Inventory (BPI) Score Baseline and 3 Days | Baseline and Day 3 | The quality of pain control will be measured using BPI, which measures two domains: pain severity and pain interference on daily activities. Scores range from 0 to 10 with lower score indicating a better outcome. |
| Change in Brief Pain Inventory (BPI) Score Baseline and 7 Days | Baseline and Day 7 | The quality of pain control will be measured using BPI, which measures two domains: pain severity and pain interference on daily activities. Scores range from 0 to 10 with lower score indicating a better outcome. |
| Change in Brief Pain Inventory (BPI) Score Baseline and 3 Weeks | Baseline and Week 3 | The quality of pain control will be measured using BPI, which measures two domains: pain severity and pain interference on daily activities. Scores range from 0 to 10 with lower score indicating a better outcome. |
| Post Study System Usability Questionnaire (PSSUQ) Score | 3 weeks | Device usability will be measured by the PSSUQ questionnaire, a 19-item scale. Scores range from 1 (strongly agree) to 7 (strongly disagree) with lower score indicating greater usability. |
| Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM) Scores | 3 weeks | Acceptability, appropriateness, and feasibility will be measured by combining AIM, IAM, and FIM scale scores. The combination of these scales demonstrates strong psychometric properties and is being used in other cancer-related and technology-based intervention research. Scores range from 1 (Strongly Disagree) to 5 (Completely Agree) with a higher score indicating a better outcome. |
Countries
United States
Contacts
CONTACTResearch Nurse Navigator
PRINCIPAL_INVESTIGATORDawn Hershman, MD
Columbia University
Outcome results
None listed