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Behavioural Intervention

Pharmacist-Led Medication Review for Cancer

Phase 1 & 2

Recruiting

Research Sponsored by University of Rochester

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be age ≥65 years

Be initiating chemotherapy, alone or in combination with other systemic antineoplastic agents, for a period of at least 3 months within 4 weeks of enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial will test whether a pharmacist-led intervention can help reduce the number of medications older adults with cancer and polypharmacy take.

Who is the study for?

This trial is for adults aged 65 or older with certain types of curable cancers (like aggressive lymphoma, breast, colon, pancreas, or lung cancer) who are starting chemotherapy and take more than 10 medications. They must be able to read/write English and give consent. Excluded are those planning surgery/radiation within 3 months or referred to a specific clinic soon.Check my eligibility

What is being tested?

The study compares two approaches: one where pharmacists help reduce the number of medicines patients take ('deprescribing'), and another focused on educating patients about their medications. Oncologists will randomly assign patients to either group to see which method is more effective during chemotherapy.See study design

What are the potential side effects?

Since this trial focuses on reducing medication use rather than testing new drugs, side effects may include withdrawal symptoms from stopping some medications or potential interactions as drug regimens change.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 65 years old or older.

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I am starting chemotherapy within 4 weeks for at least 3 months.

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I have been diagnosed with cancer in the breast, stomach, urinary system, or lung.

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I take more than 10 medications or some that may not be suitable for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change between arms in Relative dose intensity (RDI) of chemotherapy

Secondary outcome measures

Change between arms in Changes in functional status

Change between arms in Grade 3-5 chemotherapy toxicity

Hospitalizations

+2 more

Other outcome measures

Change between arms in implementation

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1: Pharmacist-led deprescribing interventionExperimental Treatment1 Intervention

Pharmacists will complete a comprehensive medication assessment with the participant via telemedicine and discuss tailored recommendations for discontinuations of potentially inappropriate medications. The pharmacist will document the evaluation and recommendations and communicate to the participant and care team members. The pharmacist will telephone each participant at least one time after the initial intervention to assess adherence to instructions and recommendations, and to assess any symptoms potentially related to medication discontinuation.

Group II: Arm 2: Patient education brochureActive Control1 Intervention

Participants will receive a brochure discussing medication appropriateness and deprescribing in general terms

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,663 Previous Clinical Trials

40,925,825 Total Patients Enrolled

University of RochesterLead Sponsor

838 Previous Clinical Trials

518,487 Total Patients Enrolled

Media Library

Pharmacist-led deprescribing (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05046171 — Phase 1 & 2

Cancer Research Study Groups: Arm 1: Pharmacist-led deprescribing intervention, Arm 2: Patient education brochure

Cancer Clinical Trial 2023: Pharmacist-led deprescribing Highlights & Side Effects. Trial Name: NCT05046171 — Phase 1 & 2

Pharmacist-led deprescribing (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05046171 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the approximate number of individuals who are participating in this experiment?

"Affirmative. The information on clinicaltrials.gov shows that this medical experiment, which was initially advertised on March 1st 2022, is actively seeking volunteers. Approximately 80 applicants need to be sourced from one clinical centre."

Answered by AI

Is this experimental research currently recruiting participants?

"According to clinicaltrials.gov, this experiment is currently searching for participants and has been since March 1st of 2022 with the latest update occuring on June 8th 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Decreasing Polypharmacy in Older Adults With Curable Cancers Trial

Erika Ramsdale 2022. "Decreasing Polypharmacy in Older Adults With Curable Cancers Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05046171.