Pilot Study of a Pharmacy Intervention for Older Adults With Cancer
- Conditions
- Breast CancerGI CancerLung Cancer
- Interventions
- Other: Usual CareOther: Pharmacy Intervention
- Registration Number
- NCT02871115
- Lead Sponsor
- Massachusetts General Hospital
- Brief Summary
The purpose of this research study is to address the challenge of medication management for older patients undergoing treatment for cancer. The sponsor of this protocol is the Massachusetts General Hospital Cancer Center who is providing funding for this research study.
- Detailed Description
The goals of the proposed study are: (1) to demonstrate the feasibility and acceptability of delivering PRIME (Pharmacist Reconciliation to Improve Medication Management in the Elderly) to older patients with breast, gastrointestinal, and lung cancers; and (2) to estimate the effect size (i.e. the magnitude of the difference between groups) of PRIME for improving medication management (e.g. accurate medication list, less polypharmacy, fewer potentially inappropriate medications) and achieving up-to-date vaccinations.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- Age 65 or older
- Diagnosed with any stage breast, GI or lung cancer
- Panning to receive first-line chemotherapy at MGH
- Verbal fluency in English
- Unwilling or unable to participate in the study
- Significant psychiatric, cognitive or other comorbid disease which the treating clinician believes prohibits informed consent or participation in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Usual Care Usual Care Participants receiving Usual Oncology Care will not meet with the pharmacist unless indicated as part of their routine clinical care * Study staff will obtain all patient-reported measures from the patient. * Remind participant to complete self-report measures Pharmacy Intervention Pharmacy Intervention Patients randomized to the pharmacy intervention (PRIME) will undergo evaluation with a clinical pharmacist at their second or third chemotherapy infusion who will * Perform detailed medication reconciliation * Obtain allergy and vaccination history * Evaluate and document polypharmacy (number of medications) * Document their findings in the medical record and discuss their recommendations (in-person, phone call, email) with each patient's oncology team
- Primary Outcome Measures
Name Time Method Rates of study enrollment 2 years To determine rates of study enrollment, we will assess the proportion of eligible patients who enroll in the study.
- Secondary Outcome Measures
Name Time Method Rates of Study Completion 2 years To determine study completion rates, we will evaluate the proportion of patients enrolled who complete the study.
Number Of Medications Baseline to 4 weeks Compare the number of medications (defined as the number of medications a patient is prescribed) between study arms at 4 weeks following enrollment.
Rates of Polypharmacy Baseline to 4 weeks Compare rates of polypharmacy (defined as five or more medications) 4 weeks following enrollment between study arms.
Change In The Number Of Potentially Inappropriate Medications Baseline to 4 weeks Compare change in the number of potentially inappropriate medications between study arms from baseline to 4 weeks following enrollment.
Number Of Potentially Inappropriate Medications Baseline to 4 weeks Compare the number of potentially inappropriate medications between study arms at 4 weeks following enrollment.
Rates Of Appropriate Pneumococcal Vaccinations Baseline to 8 weeks Compare rates of appropriate pneumococcal vaccinations (as defined by the 2016 National Comprehensive Cancer Network \[NCCN\] guidelines) between study arms at 8 weeks.
Rates Of Appropriate Influenza Vaccinations Baseline to 8 weeks Compare rates of appropriate influenza vaccinations (as defined by the 2016 National Comprehensive Cancer Network \[NCCN\] guidelines) between study arms at 8 weeks.
Rates of study satisfaction 2 years To determine rates of study satisfaction, we will examine the proportion of participants who report satisfaction with the structure, timing and content of the study, using Likert-type scale responses.
Rates of Medication List Accuracy Baseline to 4 weeks Compare rates of medication list accuracy (defined as concordance between the medical record and the medication list the patient reports taking) between study arms at 4 weeks following enrollment.
Change In The Number Of Medications Baseline to 4 weeks Compare change in the number of medications (defined as the number of medications a patient is prescribed) between study arms from baseline to 4 weeks following enrollment.
Trial Locations
- Locations (1)
Massachusetts general Hospital
🇺🇸Boston, Massachusetts, United States