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

February 12, 2025 updated by: Columbia University

Pilot Study to Assess Feasibility of a Pharmacist-Led Video Consultation to Reduce Drug Interactions Among Patients Initiating Oral Anti-Cancer Drugs

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this study, the investigator will be evaluating a 30-minute pharmacist-led video consultation to provide education about patients new oral anti-cancer drug (OACD) and help identify and manage potential drug-drug interactions alongside your oncologist. While OACDs offer both clinical benefits and added convenience when compared to traditional intravenous chemotherapy, they also present a number of potential challenges. One critical challenge involves the increased risk of taking multiple oral medications daily. Patients taking multiple medications can result in harmful effects due to unexpected drug interactions, as well as patient confusion regarding when to take specific medications. Given the relatively recent rise in available OACDs, little is known about the extent of this issue

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Video consultation group
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
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects enrolled that complete the 30 minutes consultation and assessments
Time Frame: 30 minutes
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
Time Frame: Baseline
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
Time Frame: Baseline
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mean of medication list inaccuracies among study participants prior to the consultation
Time Frame: Baseline
Based on the pre-consultation medication reconciliation, we will assess the mean number of medication list inaccuracies identified by medication reconciliation among study participants.
Baseline
Change in assess factors associated with OACD-related potential drug-drug interactions and medication inaccuracies
Time Frame: Within 30 days of the consultation
We will assess patient-level factors associated with OACD-related potential DDIs and medication inaccuracies, such as age, race/ethnicity, socioeconomic status, cancer diagnosis, number of medications, and number of comorbidities.
Within 30 days of the consultation
Number of medication changes recommended
Time Frame: Within 30 days of the consultation
The number of medication changes recommended to address polypharmacy and/or DDIs
Within 30 days of the consultation
Change in the proportion of patients with a mitigated DDI
Time Frame: Within 30 days of the consultation
The proportion of patients with a mitigated DDI, defined as a change in one involved medication within 30 days of the consultation
Within 30 days of the consultation
Change in proportion of patients with a reduction in total number of medications and/or supplements
Time Frame: Within 30 days of the consultation
The proportion of patients with a reduction in total number of medications and/or supplements within 30 days of the consultation
Within 30 days of the consultation
Change in Medication Regimen Complexity Index (MRCI) before and after the consultation
Time Frame: within 30 days of the consultation
The change in medication list complexity using the Medication Regimen Complexity Index (MRCI) within 30 days of the consultation
within 30 days of the consultation
Mean Score to Medication Self-Efficacy Scale (MASES) to assess patient confidence and competence regarding OACD administration before and after the consultation
Time Frame: Within 30 days of the consultation
The change in patient confidence and competence regarding OACD administration using a modified version of the Medication Adherence Self-Efficacy Scale (MASES-R) before and after the consultation
Within 30 days of the consultation
Change in mean score on the Satisfaction with Information about Medications Scale (SIMS) before and after the consultation
Time Frame: Within 30 days of the consultation
Patient reported outcomes as measured by the Satisfaction with Information about Medications Scale (SIMS)
Within 30 days of the consultation
Change in mean score on the Acceptability of Intervention Measure (AIM) before and after the consultation
Time Frame: Within 30 days of the consultation
Patient reported outcomes as measured by the Acceptability of Intervention Measure (AIM)
Within 30 days of the consultation
Change in mean score on the Intervention Appropriateness Measure (IAM) before and after the consultation
Time Frame: Within 30 days of the consultation
Patient reported outcomes as measured by the Intervention Appropriateness Measure (IAM)
Within 30 days of the consultation
Change in mean score on the Feasibility of Intervention Measure (FIM) before and after the consultation
Time Frame: Within 30 days of the consultation
Patient reported outcomes as measured by the Feasibility of Intervention Measure (FIM)
Within 30 days of the consultation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Columbia University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dawn Hershman, MD, 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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 5, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 5, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 25, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AAAT3167

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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