Breast Cancer, GI Cancer, Lung Cancer
Conditions
Keywords
Cancer Care
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.
Interventions
OTHERPharmacy Intervention
Patients randomized to the pharmacy intervention (PRIME) will undergo evaluation with a clinical pharmacist at their second or third chemotherapy infusion who will: (1) perform detailed medication reconciliation and obtain allergy and vaccination history; (2) evaluate and document polypharmacy, potentially inappropriate medications, lack of appropriate medications; and (3) document their findings in the medical record and discuss their recommendations the oncology team.
OTHERUsual 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.
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 Study Completion | 2 years | To determine study completion rates, we will evaluate the proportion of patients enrolled who complete the study. |
| 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 4 weeks | Compare rates of appropriate pneumococcal vaccinations (as defined by the 2016 National Comprehensive Cancer Network \[NCCN\] guidelines) between study arms at 4 weeks. |
| Rates Of Appropriate Influenza Vaccinations | Baseline to 4 weeks | Compare rates of appropriate influenza vaccinations (as defined by the 2016 National Comprehensive Cancer Network \[NCCN\] guidelines) between study arms at 4 weeks. |
| Rates of Polypharmacy | Baseline to 4 weeks | Compare rates of polypharmacy (defined as five or more medications) 4 weeks following enrollment between study arms. |
Countries
United States
Outcome results
None listed