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Completed

NCT Number: NCT02871115

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms GI Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts general Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pharmacy Intervention

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

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.

Primary outcomes

  1. Rates of study enrollment

    Time frame: 2 years

    To determine rates of study enrollment, we will assess the proportion of eligible patients who enroll in the study.

Secondary outcomes

  1. Rates of Study Completion

    Time frame: 2 years

    To determine study completion rates, we will evaluate the proportion of patients enrolled who complete the study.

  2. Rates of study satisfaction

    Time frame: 2 years

    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.

  3. Rates of Medication List Accuracy

    Time frame: Baseline to 4 weeks

    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.

  4. Change In The Number Of Medications

    Time frame: Baseline to 4 weeks

    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.

  5. Number Of Medications

    Time frame: Baseline to 4 weeks

    Compare the number of medications (defined as the number of medications a patient is prescribed) between study arms at 4 weeks following enrollment.

  6. Rates of Polypharmacy

    Time frame: Baseline to 4 weeks

    Compare rates of polypharmacy (defined as five or more medications) 4 weeks following enrollment between study arms.

  7. Change In The Number Of Potentially Inappropriate Medications

    Time frame: Baseline to 4 weeks

    Compare change in the number of potentially inappropriate medications between study arms from baseline to 4 weeks following enrollment.

  8. Number Of Potentially Inappropriate Medications

    Time frame: Baseline to 4 weeks

    Compare the number of potentially inappropriate medications between study arms at 4 weeks following enrollment.

  9. Rates Of Appropriate Pneumococcal Vaccinations

    Time frame: Baseline to 4 weeks

    Compare rates of appropriate pneumococcal vaccinations (as defined by the 2016 National Comprehensive Cancer Network [NCCN] guidelines) between study arms at 4 weeks.

  10. Rates Of Appropriate Pneumococcal Vaccinations

    Time frame: Baseline to 8 weeks

    Compare rates of appropriate pneumococcal vaccinations (as defined by the 2016 National Comprehensive Cancer Network [NCCN] guidelines) between study arms at 8 weeks.

  11. Rates Of Appropriate Influenza Vaccinations

    Time frame: Baseline to 4 weeks

    Compare rates of appropriate influenza vaccinations (as defined by the 2016 National Comprehensive Cancer Network [NCCN] guidelines) between study arms at 4 weeks.

  12. Rates Of Appropriate Influenza Vaccinations

    Time frame: Baseline to 8 weeks

    Compare rates of appropriate influenza vaccinations (as defined by the 2016 National Comprehensive Cancer Network [NCCN] guidelines) between study arms at 8 weeks.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 18, 2016
Registry last updated
Nov 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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