NCT02871115

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2017

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 13, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2018

Completed
Last Updated

November 12, 2021

Status Verified

November 1, 2021

Enrollment Period

1 year

First QC Date

August 13, 2016

Last Update Submit

November 11, 2021

Conditions

Breast CancerLung CancerGI Cancer

Keywords

Cancer Care

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Rates of Study Completion

    2 years

  • Rates of study satisfaction

    2 years

  • Rates of Medication List Accuracy

    Baseline to 4 weeks

  • Change In The Number Of Medications

    Baseline to 4 weeks

  • Number Of Medications

    Baseline to 4 weeks

  • +7 more secondary outcomes

Study Arms (2)

Pharmacy Intervention

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Pharmacy InterventionOTHER

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.

Pharmacy Intervention
Usual CareOTHER

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.

Usual Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Breast NeoplasmsLung NeoplasmsGastrointestinal Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesDigestive System NeoplasmsDigestive System DiseasesGastrointestinal Diseases

Study Officials

  • Ryan Nipp, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 13, 2016

First Posted

August 18, 2016

Study Start

January 1, 2017

Primary Completion

January 2, 2018

Study Completion

April 14, 2018

Last Updated

November 12, 2021

Record last verified: 2021-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)