Reducing medication use in older cancer patients starting chemotherapy
Decreasing Polypharmacy in Older Adults With Curable Cancers: a Pilot Cluster-randomized Trial
This study tests if having a pharmacist help older cancer patients cut back on unnecessary medications can improve their treatment experience when they start chemotherapy.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | University of Rochester Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 1 site (Rochester, New York) |
| Trial ID | NCT05046171 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of a pharmacist-led deprescribing intervention compared to patient education for older adults with curable cancers who are starting chemotherapy and are experiencing polypharmacy. The study involves a single-site cluster-randomized design where oncologists will enroll patients and assign them to one of the two interventions. Initial focus groups with healthcare professionals and patients will help refine the deprescribing approach before the main trial begins. The goal is to assess the impact of reducing unnecessary medications on treatment outcomes and patient well-being.
Who should consider this trial
Good fit: Ideal candidates are older adults aged 65 and above who have a diagnosis of curable cancer and are starting chemotherapy while taking more than 10 medications.
Not a fit: Patients who are not receiving standard cytotoxic chemotherapy or those with planned treatments that do not include chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment adherence and better health outcomes for older cancer patients by minimizing the risks associated with polypharmacy.
How similar studies have performed: While deprescribing has been studied in other populations, this specific approach in older adults with cancer receiving chemotherapy is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rochester, New York
- University of Rochester — Rochester, New York, United States (Recruiting)
Study contacts
- Study coordinator: Erika Ramsdale
- Email: Erika_Ramsdale@URMC.Rochester.edu
- Phone: 585-275-5863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.