Pilot Study of a Pharmacy Intervention for Older Adults With Cancer

Study Overview
=================
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.

Official Title
-----------------
Pilot Study of a Pharmacy Intervention for Older Adults With Cancer

Conditions
-----------------
Breast Cancer, Lung Cancer, GI Cancer

Intervention / Treatment
-----------------
* Other: Pharmacy Intervention
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: Pharmacy Intervention<br>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 | Other: Pharmacy Intervention<br>* 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.<br>|
| Active Comparator: Usual Care<br>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 | Other: Usual Care<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of study enrollment | To determine rates of study enrollment, we will assess the proportion of eligible patients who enroll in the study. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of Study Completion | To determine study completion rates, we will evaluate the proportion of patients enrolled who complete the study. | 2 years | 
| Rates of study satisfaction | 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. | 2 years | 
| Rates of Medication List Accuracy | 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. | Baseline to 4 weeks | 
| Change In The Number Of Medications | 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. | Baseline to 4 weeks | 
| Number Of Medications | Compare the number of medications (defined as the number of medications a patient is prescribed) between study arms at 4 weeks following enrollment. | Baseline to 4 weeks | 
| Rates of Polypharmacy | Compare rates of polypharmacy (defined as five or more medications) 4 weeks following enrollment between study arms. | Baseline to 4 weeks | 
| Change In The Number Of Potentially Inappropriate Medications | Compare change in the number of potentially inappropriate medications between study arms from baseline to 4 weeks following enrollment. | Baseline to 4 weeks | 
| Number Of Potentially Inappropriate Medications | Compare the number of potentially inappropriate medications between study arms at 4 weeks following enrollment. | Baseline to 4 weeks | 
| Rates Of Appropriate Pneumococcal Vaccinations | Compare rates of appropriate pneumococcal vaccinations (as defined by the 2016 National Comprehensive Cancer Network [NCCN] guidelines) between study arms at 4 weeks. | Baseline to 4 weeks | 
| Rates Of Appropriate Pneumococcal Vaccinations | Compare rates of appropriate pneumococcal vaccinations (as defined by the 2016 National Comprehensive Cancer Network [NCCN] guidelines) between study arms at 8 weeks. | Baseline to 8 weeks | 
| Rates Of Appropriate Influenza Vaccinations | Compare rates of appropriate influenza vaccinations (as defined by the 2016 National Comprehensive Cancer Network [NCCN] guidelines) between study arms at 4 weeks. | Baseline to 4 weeks | 
| Rates Of Appropriate Influenza Vaccinations | Compare rates of appropriate influenza vaccinations (as defined by the 2016 National Comprehensive Cancer Network [NCCN] guidelines) between study arms at 8 weeks. | Baseline to 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer Care