Decreasing Polypharmacy in Older Adults With Curable Cancers Trial

NCT05046171 | Completed Phase 1 DMC

• 2 other identifiers: UMLT19186K08CA248721
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Keywords

Older Adults; Cancer receiving chemotherapy; Polypharmacy

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (6)

• Change between arms in Changes in functional status

  12 Weeks

• Change between arms in Changes in functional status

  12 Weeks

• Change between arms in Grade 3-5 chemotherapy toxicity

  12 Weeks

• Hospitalizations

  12 Weeks

• Patient-reported falls

  12 Weeks

Other Outcomes (1)

• Change between arms in implementation

  2 years

Study Arms (2)

Arm 1: Pharmacist-led deprescribing intervention

EXPERIMENTAL

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

Arm 2: Patient education brochure

ACTIVE COMPARATOR

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

Other: Patient education

Interventions

Pharmacist-led deprescribing OTHER

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.

Arm 1: Pharmacist-led deprescribing intervention

Patient education OTHER

Subjects receive a written pamphlet about deprescribing.

Arm 2: Patient education brochure

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

Related Publications (2)

• Ramsdale E, Mohamed M, Holmes HM, Zubkoff L, Bauer J, Norton SA, Mohile S. Decreasing polypharmacy in older adults with cancer: A pilot cluster-randomized trial protocol. J Geriatr Oncol. 2024 Mar;15(2):101687. doi: 10.1016/j.jgo.2023.101687. Epub 2024 Feb 1.

  PMID: 38302299 DERIVED

• Ramsdale E, Malhotra A, Holmes HM, Zubkoff L, Wang J, Mohile S, Norton SA, Duberstein PR. Emotional barriers and facilitators of deprescribing for older adults with cancer and polypharmacy: a qualitative study. Support Care Cancer. 2023 Oct 17;31(12):636. doi: 10.1007/s00520-023-08084-9.

  PMID: 37847423 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

Patient Education as Topic

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor - Department of Medicine , Hematology/Oncology (SMD)

Study Record Dates

• First Submitted: August 30, 2021
• First Posted: September 16, 2021
• Study Start: June 14, 2022
• Primary Completion: August 23, 2025
• Study Completion: August 30, 2025
• Last Updated: March 24, 2026

Record last verified: 2025-03

Locations

US (1)