NCT05046171

Decreasing Polypharmacy in Older Adults With Curable Cancers Trial

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cancer

Interventions

Type	Name	Description
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.
OTHER	Patient education	Subjects receive a written pamphlet about deprescribing.

Timeline

• Start date: 2022-06-14
• Primary completion: 2025-08-23
• Completion: 2025-08-30
• First posted: 2021-09-16
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States