Pilot Study of a Pharmacy Intervention for Older Adults With Cancer

Breast Cancer Clinical Trial

Official title:

Pilot Study of a Pharmacy Intervention for Older Adults With Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02871115
• Other study ID #: 16-230
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: April 14, 2018

Study information

• Verified date: November 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: April 14, 2018
• Est. primary completion date: January 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• GI Cancer
• Lung Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts general Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Rates of Study Completion	To determine study completion rates, we will evaluate the proportion of patients enrolled who complete the study.	2 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rates of Polypharmacy	Compare rates of polypharmacy (defined as five or more medications) 4 weeks following enrollment between study arms.	Baseline to 4 weeks
Secondary	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
Secondary	Number Of Potentially Inappropriate Medications	Compare the number of potentially inappropriate medications between study arms at 4 weeks following enrollment.	Baseline to 4 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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