Pilot Study of a Pharmacy Intervention for Older Adults With Cancer

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Lung Cancer; GI Cancer
• Intervention / Treatment: Other: Pharmacy Intervention; Other: Usual Care

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.

• Study Type: Interventional
• Enrollment (Actual): 62
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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: (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.
Active Comparator: 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	Other: 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.

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

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Ryan Nipp, MD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2017
• Primary Completion (Actual): January 2, 2018
• Study Completion (Actual): April 14, 2018

Study Registration Dates

• First Submitted: August 13, 2016
• First Submitted That Met QC Criteria: August 17, 2016
• First Posted (Estimate): August 18, 2016

Study Record Updates

• Last Update Posted (Actual): November 12, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Cancer Care
• Other Study ID Numbers: 16-230

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO