Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center for Patients With Solid Tumor

NCT04122118 | Completed DMC

• 2 other identifiers: 19D.411JT 13521
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies how well pharmacist-led transitions of care works in the outpatient oncology infusion center for patients with solid tumor. Having a pharmacist in the outpatient oncology infusion center may help to identify and correct medical related problems and improve overall patient and staff satisfaction. Patients receiving education may benefit from gaining a better understanding of their antineoplastic therapy. Understanding the side effects associated with the therapy may also help patients better be prepared to manage any adverse effects they may experience.

Conditions

Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• Number of medical related problem (MRP)s identified by the pharmacist through retrospective chart reviews (Phase I)

  MRPs will be assigned to a specific category and the total number of MRPs in each category will be recorded. Categories include but are not limited to: incorrect dose, therapeutic duplication, drug not indicated, drug interaction, monitoring recommendation, drug allergy, or potential for adverse event.

  Up to 1 year

• Percent of MRPs corrected as a result of the clinical oncology pharmacist services (Phase II)

  In phase 2 (prospective) MRPs will also be recorded and categorized, but in addition the outcomes relating to each MRP pharmacist intervention will be recorded. MRPs found by the pharmacist will be communicated to the patient's oncologist or primary care provider, and the pharmacist will follow-up to see if changes were made.

  Up to 1 year

Secondary Outcomes (1)

• Patient and provider satisfaction with the pharmacist-led education

  Up to 1 year

Other Outcomes (1)

• Estimate of Cost avoidance utilizing pharmacy services

  Up to 1 year

Study Arms (1)

Hearth services research (pharmacist-led education)

EXPERIMENTAL

PHASE I: Patients' medical records are reviewed. PHASE II: Patients receive pharmacist-led education on antineoplastic therapies including what to expect during infusion, general drug facts, common adverse effects, side effect management, and when to contact provider.

Other: Medical Chart Review; Other: Educational Intervention; Other: Survey Administration

Interventions

Medical Chart Review OTHER

Review of medical chart

Also known as: Chart Review

Hearth services research (pharmacist-led education)

Educational Intervention OTHER

Receive pharmacist-led education

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Educational

Hearth services research (pharmacist-led education)

Survey Administration OTHER

Ancillary studies

Hearth services research (pharmacist-led education)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Solid tumor diagnosis
• Starting day 1 of new antineoplastic infusion
• English speaking (and/or English-speaking primary caregiver/proxy)

You may not qualify if:

• Metastasis to the brain and/or central nervous system (CNS) with evidence of impaired cognition
• Severe cognitive impairment including dementia with inability to consent to the study

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Interventions

Early Intervention, Educational; Educational Status; Methods

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques

Study Officials

• Gloria Espinosa, PharmD

  Sidney Kimmel Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 10, 2019
• Study Start: September 25, 2019
• Primary Completion: March 5, 2021
• Study Completion: March 5, 2021
• Last Updated: April 29, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)