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Pilot Study of a Pharmacy Intervention for Older Adults With Cancer

NCT ID: NCT02871115

Last Updated: 2021-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2018-04-14

Brief Summary

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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

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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.

Conditions

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Breast Cancer Lung Cancer GI Cancer

Keywords

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Cancer Care

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Pharmacy Intervention

Intervention Type OTHER

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.
* Remind participant to complete self-report measures

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ryan Nipp

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ryan Nipp, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts general Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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16-230

Identifier Type: -

Identifier Source: org_study_id