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Completed

NCT Number: NCT05046171

Decreasing Polypharmacy in Older Adults With Curable Cancers Trial

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.

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Key information

Conditions

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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 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.

Treatment and study plan

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.

Patient Education

Other

Subjects receive a written pamphlet about deprescribing.

Primary outcomes

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

    Time frame: 12 Weeks

    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.

Secondary outcomes

  1. Change between arms in Changes in functional status

    Time frame: 12 Weeks

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

  2. Change between arms in Changes in functional status

    Time frame: 12 Weeks

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

  3. Change between arms in Grade 3-5 chemotherapy toxicity

    Time frame: 12 Weeks

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

  4. Hospitalizations

    Time frame: 12 Weeks

    assessed as ≥1 or 0

  5. Patient-reported falls

    Time frame: 12 Weeks

    assessed as ≥1 or 0

  6. Patient-reported symptoms

    Time frame: 12 Weeks

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

Other outcomes

  1. Change between arms in implementation

    Time frame: 2 years

    Barriers and facilitators of intervention (implementation outcome)

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 16, 2021
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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