Opioid Dispensing Device for Post-Operative Pain in Cancer Patients Patients

Not Applicable

Recruiting

• Conditions: Breast Cancer; Opioid Use
• Interventions: Device: Addinex Device (ADX-27)

• Registration Number: NCT05585788
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2020-10-05
• Study First Submitted: 2022-03-09
• Study First Submitted QC: 2022-10-14
• Study First Posted: 2022-10-19
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-15
• Last Update Posted: 2024-04-17
• Primary Completion: 2026-05-01
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Addinex system	Addinex Device (ADX-27)	The Addinex system is designed to dispense opioid medication to patients on a provider-determined schedule, to track patient 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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States