Tumor biopsy

Shawn D. Glisson, MD

The purpose of this study is to identify the genetic makeup of cancers, the cancer response, and the correlation of the cancer response to standardized regimens of cancer treatment.

To identify the genetic makeup of cancers, the cancer response, and the correlation of the cancer response to standardized regimens of cancer treatment.

Tumor Phenotypes and Correlation to Clinical Outcomes in Cancer

Identification of Tumor Phenotypes and Correlation to Clinical Outcomes in Patients Diagnosed With Cancer

Kentuckiana Cancer Institute

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.

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

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.

Pharmacist-led deprescribing

Subjects receive a written pamphlet about deprescribing.

Patient education

Erika Ramsdale

Lauren Mitchell

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.

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.

Decreasing Polypharmacy in Older Adults With Curable Cancers Trial

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

Barriers and facilitators of intervention (implementation outcome)

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.

Changes in functional status, based on Instrumental Activities of Daily Living (IADL)

Changes in functional status, based on Activities of Daily Living (ADL)

Grade 3-5 chemotherapy toxicity based on Common Terminology Criteria for Adverse Events (CTCAE) v.5

Patient-reported symptoms, assessed by selected elements of the NCI Patient Reported Outcomes CTCAE (PRO-CTCAE, 10-20 items).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tumor Phenotypes and Correlation to Clinical Outcomes in Cancer	NCT00283530	Cancer	Tumor biopsy	18 Years -	Kentuckiana Cancer Institute
Decreasing Polypharmacy in Older Adults With Curable Cancers Trial	NCT05046171	Cancer	Pharmacist-led ... Patient educati...	65 Years -	University of Rochester
Decreasing Polypharmacy in Older Adults With Curable Cancers Trial	NCT05046171	Cancer	Pharmacist-led ... Patient educati...	65 Years -	University of Rochester

Spots Global Cancer Trial Database for cancer receiving chemotherapy