CancerNCT05299671
Video Consultation to Reduce Drug Interactions Among Patients Initiating Oral Anti-Cancer Drugs
A study testing Video consultation in people with Cancer, run by Columbia University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Video consultation
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2021to 5 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: 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.
Read the 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
- Conditions
- Cancer
- Being tested
- Video consultation
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video consultationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Video consultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline
Secondary outcomes (11)
Mean of medication list inaccuracies among study participants prior to the consultation
Based on the pre-consultation medication reconciliation, we will assess the mean number of medication list inaccuracies identified by medication reconciliation among study participants.
Measured: Baseline
Change in assess factors associated with OACD-related potential drug-drug interactions and medication inaccuracies
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.
Measured: Within 30 days of the consultation
Number of medication changes recommended
The number of medication changes recommended to address polypharmacy and/or DDIs
Measured: Within 30 days of the consultation
Change in the proportion of patients with a mitigated DDI
The proportion of patients with a mitigated DDI, defined as a change in one involved medication within 30 days of the consultation
Measured: Within 30 days of the consultation
Change in proportion of patients with a reduction in total number of medications and/or supplements
The proportion of patients with a reduction in total number of medications and/or supplements within 30 days of the consultation
Measured: Within 30 days of the consultation
Change in Medication Regimen Complexity Index (MRCI) before and after the consultation
The change in medication list complexity using the Medication Regimen Complexity Index (MRCI) within 30 days of the consultation
Measured: 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
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
Measured: Within 30 days of the consultation
Change in mean score on the Satisfaction with Information about Medications Scale (SIMS) before and after the consultation
Patient reported outcomes as measured by the Satisfaction with Information about Medications Scale (SIMS)
Measured: Within 30 days of the consultation
Change in mean score on the Acceptability of Intervention Measure (AIM) before and after the consultation
Patient reported outcomes as measured by the Acceptability of Intervention Measure (AIM)
Measured: Within 30 days of the consultation
Change in mean score on the Intervention Appropriateness Measure (IAM) before and after the consultation
Patient reported outcomes as measured by the Intervention Appropriateness Measure (IAM)
Measured: Within 30 days of the consultation
Change in mean score on the Feasibility of Intervention Measure (FIM) before and after the consultation
Patient reported outcomes as measured by the Feasibility of Intervention Measure (FIM)
Measured: Within 30 days of the consultation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study start22 Jun 2021
- Primary completion5 May 2023
- Study completion5 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dawn Hershman, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299671
- Sponsor's protocol ID
- AAAT3167
- Status last verified
- Feb 2025
- First submitted
- 25 Jan 2022
- Last updated
- 14 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Assess Feasibility of a Pharmacist-Led Video Consultation to Reduce Drug Interactions Among Patients Initiating Oral Anti-Cancer Drugs
- ClinicalTrials.gov ID
- NCT05299671
- Acronym / sponsor ID
- AAAT3167
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Study start
- 22 Jun 2021 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 29 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video consultation group | Experimental | Behavioral: Video consultationPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video consultationDuring 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. | Behavioural | Video consultation group |
Primary outcome
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.
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.
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.
11 secondary outcomes
Mean of medication list inaccuracies among study participants prior to the consultation
Time frame: Baseline
Change in assess factors associated with OACD-related potential drug-drug interactions and medication inaccuracies
Time frame: Within 30 days of the consultation
Number of medication changes recommended
Time frame: Within 30 days of the consultation
Change in the proportion of patients with a mitigated DDI
Time frame: 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
Change in Medication Regimen Complexity Index (MRCI) before and after the consultation
Time frame: 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
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
Change in mean score on the Acceptability of Intervention Measure (AIM) before and after the consultation
Time frame: 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
Change in mean score on the Feasibility of Intervention Measure (FIM) before and after the consultation
Time frame: Within 30 days of the consultation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Hershman, MD principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video consultation in people with Cancer, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects enrolled that complete the 30 minutes consultation and assessments (time frame: 30 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.