Decreasing Polypharmacy in Older Adults With Curable Cancers Trial

August 17, 2026 updated by: Erika Ramsdale, University of Rochester

Decreasing Polypharmacy in Older Adults With Curable Cancers: a Pilot Cluster-randomized Trial

This is a single-site cluster-randomized trial to assess efficacy and implementation outcomes of deprescribing interventions in 72 older adults with polypharmacy (PP) and curable cancers initiating chemotherapy. Oncologists (as the cluster) will enroll 6 patients each and will be randomized to either a pharmacist-led deprescribing intervention or patient education intervention. Initial focus groups with oncologists, nurses, pharmacists, primary care physicians, and patients will provide data for initial adaptations to the pharmacist-led intervention arm, and 8 patients will be enrolled as a pre-trial cohort to further refine and adapt the pharmacist-led intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Polypharmacy (PP), or the concurrent use of multiple medications, affects up to 92% of older adults with cancer. It has been associated with adverse outcomes in these patients including poor adherence to and tolerance of cancer therapy, decrease in physical functioning, unplanned hospitalizations, falls, increased symptoms, and lower survival. "Deprescribing," or the planned discontinuation of medications which may be potentially unsafe or inappropriate, is an intervention strategy which has the potential to decrease PP and improve outcomes. Deprescribing has not been studied in older adults with cancer receiving chemotherapy. The proposed study will adapt and refine potentially scalable deprescribing interventions, investigate the effects of deprescribing interventions on relative dose intensity and other adverse outcomes in older adults undergoing curative-intent chemotherapy, and identify barriers and facilitators of deprescribing interventions for patients, oncologists, and pharmacists. Focus groups and interviews with pharmacists, oncologists, nurses, primary care providers, and patient advocates will allow initial adaptation of the proposed interventions. A "pre-pilot" cohort of 8 patients with PP and cancer planned to receive curative-intent chemotherapy will undergo a pharmacist-led deprescribing intervention with additional iterative adaptations. Then, 72 patients will be allocated to a pharmacist-led deprescribing intervention versus patient education intervention in a cluster-randomized trial of 12 oncologist clusters.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2
  • Phase 1

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
      • Rochester, New York, United States, 14642
        • University of Rochester

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

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Be age ≥65 years;
  • Have a diagnosis of malignancy including aggressive lymphoma or cancers of the breast, gastrointestinal system, genitourinary system, or lung;
  • 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;
  • Screen positive for polypharmacy (>10 medications) or potentially inappropriate medications
  • Be able to read and write English;
  • Be able to give informed consent, as determined by the primary oncologist, or has a legally authorized representative to sign consent in the case of cognitive impairment.

Exclusion Criteria:

  • Be planned to receive a cancer treatment regimen that does not include standard cytotoxic chemotherapy (e.g., only targeted therapies, hormonal therapies, monoclonal antibody therapies, immunotherapy, etc.),
  • Have surgery or radiation without concurrent chemotherapy planned within 3 months of consent,
  • Have a planned referral to the geriatric oncology clinic (SOCARE) within one month of treatment initiation,
  • Lack decisional capacity, if a legally authorized representative is not available to sign consent and participate in study visits and follow-up phone calls.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm 1: Pharmacist-led deprescribing 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.
Other: Pharmacist-led deprescribing
A pharmacist recruited onto the study will review the patient's current medication list and develop a list of targeted recommendations for deprescribing using the 3-step potentially inappropriate medications identification method.
Active Comparator: Arm 2: Patient education brochure
Participants will receive a brochure discussing medication appropriateness and deprescribing in general terms
Other: Patient education
Subjects receive a written pamphlet about deprescribing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change between arms in Relative dose intensity (RDI) of chemotherapy
Time Frame: 12 Weeks
Relative dose intensity (RDI) of chemotherapy, based upon standard dosing from National Comprehensive Cancer Network guidelines or similar reference. RDI assesses the proportion of planned therapy that the patient receives within 12 weeks of initiation of chemotherapy.
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change between arms in Changes in functional status
Time Frame: 12 Weeks
Changes in functional status, based on Instrumental Activities of Daily Living (IADL)
12 Weeks
Change between arms in Changes in functional status
Time Frame: 12 Weeks
Changes in functional status, based on Activities of Daily Living (ADL)
12 Weeks
Change between arms in Grade 3-5 chemotherapy toxicity
Time Frame: 12 Weeks
Grade 3-5 chemotherapy toxicity based on Common Terminology Criteria for Adverse Events (CTCAE) v.5
12 Weeks
Hospitalizations
Time Frame: 12 Weeks
assessed as ≥1 or 0
12 Weeks
Patient-reported falls
Time Frame: 12 Weeks
assessed as ≥1 or 0
12 Weeks
Patient-reported symptoms
Time Frame: 12 Weeks
Patient-reported symptoms, assessed by selected elements of the NCI Patient Reported Outcomes CTCAE (PRO-CTCAE, 10-20 items).
12 Weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change between arms in implementation
Time Frame: 2 years
Barriers and facilitators of intervention (implementation outcome)
2 years

Collaborators and Investigators

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

Sponsor

University of Rochester

Collaborators

National Cancer Institute (NCI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

June 14, 2022

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

August 30, 2021

First Submitted That Met QC Criteria

September 7, 2021

First Posted (Actual)

September 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 19, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMLT19186
  • K08CA248721 (U.S. NIH Grant/Contract)

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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