RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Efficacy of a Pill-Dispensing System to Increase Disposal of Unused Opioids and to Reduce Refills After Cancer-Related Surgery

Quick Facts

Study Start:2020-10-05
Study Completion:2026-05-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05585788

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adult patients (age greater than or equal to 18 years)
  2. * Planned for major cancer-related surgery and expected to receive a postoperative opioid prescription
  3. * Must speak English or Spanish
  4. * Must have access to a smartphone or an alternative smart device (e.g., iPhone, Android phone, iPad, Surface, etc.).
  5. * Co-enrollment in trials involving pharmacologic therapy is allowed
  1. * Patients who are taking opioids daily prior to the surgical procedure
  2. * Patients unable to physically utilize the device
  3. * Patients unable to self-administer medications
  4. * Patients uncomfortable with using iPhone or iPad-based technology

Contacts and Locations

Study Contact

Research Nurse Navigator
CONTACT
212-342-5162
cancerclinicaltrials@cumc.columbia.edu

Principal Investigator

Dawn Hershman, MD
PRINCIPAL_INVESTIGATOR
Columbia University

Study Locations (Sites)

Columbia University Medical Center
New York, New York, 10032
United States

Collaborators and Investigators

Sponsor: Columbia University

  • Dawn Hershman, MD, PRINCIPAL_INVESTIGATOR, Columbia University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-10-05
Study Completion Date2026-05-01

Study Record Updates

Study Start Date2020-10-05
Study Completion Date2026-05-01

Terms related to this study

Additional Relevant MeSH Terms

  • Opioid Use
  • Breast Cancer