Decreasing polypharmacy in older adults with cancer: A pilot cluster-randomized trial protocol

Polypharmacy is prevalent in older adults with cancer and associated with multiple adverse outcomes. A single-site, cluster-randomized clinical trial will enroll older adults with cancer and polypharmacy starting chemotherapy and will assess the effectiveness and feasibility of deprescribing interventions by comparing two arms: a pharmacist-led deprescribing intervention and a patient educational brochure.

The study will be conducted in two phases. In phase I, focus groups and semi-structured individual interviews will guide adaptation of deprescribing interventions for the oncology clinic (phase Ia), and eight patients will undergo the pharmacist-led deprescribing intervention with iterative adaptations (phase Ib). In phase II, a pilot cluster-randomized trial (n = 72) will compare a pharmacist-led deprescribing intervention with a patient education brochure, with treating oncologists as the cluster. Both efficacy (relative dose intensity of planned chemotherapy, potentially inappropriate medications successfully deprescribed, chemotherapy toxicity, functional status, hospitalizations, falls, and symptoms) and implementation outcomes (barriers and facilitators) will be assessed.

This study is anticipated to provide pilot data to inform a nationwide randomized clinical trial of deprescribing in older adults starting cancer treatment. The cluster randomization is intended to provide an initial estimate for the intervention effect as well as oncologists' intra-class correlation coefficient. Deprescribing interventions may improve outcomes in older adults starting cancer treatment, but these interventions are understudied in this population, and it is unknown how best to implement them into oncology practice. The results of this trial will inform the design of large, randomized phase III trials of deprescribing.

gov Identifier:NCT05046171. Date of registration: September 16, 2021.