Video Consultation to Reduce Drug Interactions Among Patients Initiating Oral Anti-Cancer Drugs

NCT05299671 | Completed

• 1 other identifier: AAAT3167
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This is a non-randomized prospective pilot intervention study to assess the feasibility of a onetime pharmacist-led video consultation for medication review and patient education among patients initiating an oral anti-cancer drug. In addition, investigator will evaluate reductions in polypharmacy, potential DDIs, and patient self-efficacy by comparing these variables for each patient before and after the video consultation.

Conditions

Cancer

Outcome Measures

Primary Outcomes (3)

• Proportion of subjects enrolled that complete the 30 minutes consultation and assessments

  To determine feasibility of a one-time pharmacist-led video consultation among advanced cancer patients initiating oral anti-cancer drugs. Feasibility will be defined as significant evidence that 50% of enrolled patients will complete all components of the study.

  30 minutes

• Rate of absorption interaction

  Based on the pre-consultation medication reconciliation, we will assess the characteristics (absorption interaction) of medication list inaccuracies identified by medication reconciliation among study participants.

  Baseline

• Average of QTc prolongation

  Based on the pre-consultation medication reconciliation, we will assess the characteristics ( QTc prolongation) of medication list inaccuracies identified by medication reconciliation among study participants.

  Baseline

Secondary Outcomes (11)

• Mean of medication list inaccuracies among study participants prior to the consultation

  Baseline

• Change in assess factors associated with OACD-related potential drug-drug interactions and medication inaccuracies

  Within 30 days of the consultation

• Number of medication changes recommended

  Within 30 days of the consultation

• Change in the proportion of patients with a mitigated DDI

  Within 30 days of the consultation

• Change in proportion of patients with a reduction in total number of medications and/or supplements

  Within 30 days of the consultation

Study Arms (1)

Video consultation group

EXPERIMENTAL

Patients starting a new oral anti-cancer drug (OACD) will receive help to identify and manage potential drug-drug interactions alongside patient's oncologist through a one-time video consultation.

Behavioral: Video consultation

Interventions

Video consultation BEHAVIORAL

During the video visit, a pharmacist will speak with the patient about potential drug-drug interactions between the patient's cancer treatment and the other medications on the list, make recommendations about medication management (which will also be directly communicated to the oncologist), provide education about the patient's new OACD, and answer any questions. The virtual consultation will last about 30 minutes via an electronic device.

Video consultation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults age ≥18 years
• Patients must have access to a smartphone, tablet, or computer to facilitate a video visit, or be willing to come into the hospital to borrow a tablet for the visit
• Patients must have received a prescription for a new oral anti-cancer drug within 4 weeks of enrollment, not administered as part of a clinical trial
• Patients must take at least three prescribed, standing oral medications in addition to their newly prescribed anti-cancer drug

You may not qualify if:

• Patients who do not speak English or Spanish
• Patients without cognitive capacity to give informed consent for participation
• Patients uncomfortable with using video-based technology

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Dawn Hershman, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2022
• First Posted: March 29, 2022
• Study Start: June 22, 2021
• Primary Completion: May 5, 2023
• Study Completion: May 5, 2023
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

US (1)