Decreasing Polypharmacy in Older Adults With Curable Cancers Trial

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Other: Pharmacist-led deprescribing
* Other: Patient education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be age ≥65 years; Have a diagnosis of potentially curable malignancy including aggressive lymphoma or cancers of the breast, colon, pancreas, or lung (non-small cell); Be initiating curative-intent chemotherapy, alone or in combination with other systemic antineoplastic agents, (for a period of at least 3 months) within 4 weeks after 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 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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1: Pharmacist-led deprescribing intervention<br>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<br>* 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.<br>|
| Active Comparator: Arm 2: Patient education brochure<br>Participants will receive a brochure discussing medication appropriateness and deprescribing in general terms | Other: Patient education<br>* Subjects receive a written pamphlet about deprescribing.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Older Adults, Cancer receiving chemotherapy, Polypharmacy