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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05965206
Other study ID # Study00002683
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 20, 2023
Est. completion date July 31, 2025

Study information

Verified date July 2023
Source Cedars-Sinai Medical Center
Contact Suwicha Limvorasak, PharmD
Phone 310-423-0634
Email suwicha.limvorasak@cshs.org
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine the impact of pharmacists on reducing chemotherapy-related side effects by providing education before and after patients receive intravenous chemotherapy at one of Cedars-Sinai outpatient infusion centers. Participants will be interviewed via telephone within 7 business days after receiving intravenous chemotherapy from the outpatient cancer center infusion clinic.


Description:

The study involves participation at a single timepoint only. Participants who consented to participate and are considered eligible will be interviewed by a pharmacist via phone at approximately 7 business days after receiving intravenous chemotherapy infusion. Phone call will be made between the hours of 9am - 6pm on Monday - Saturday. Calls are anticipated to last between 15 to 20 minutes. Participants will be asked if they have experienced any adverse events since the infusion, whether or not they have had any barriers taking supportive care medications, and if the patient understands how to manage potential adverse events. If applicable, participants will be provided further education on optimizing adverse events, guided on proper medication administration times, and will be provided with non-pharmacological clinical pearls to minimize chemotherapy-related side effects and optimize supportive care management. If unable to reach the participant or caregiver after three attempts, the participant will be considered ineligible. Participants can decline participation at any time during the phone call.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date July 31, 2025
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - At least 18 years old - Diagnosed with cancer and is receiving treatment with intravenous chemotherapy - Treatment initiated at Cedars-Sinai Cancer Samuel Oschin Cancer Center (SOCC) or Cedars-Sinai Cancer Beverly Hills (CSCBH) - English-speaking or lives with English-speaking person - Access to a working phone Exclusion Criteria: - Received follow-up calls through other specialty pharmacy program - History of infusion related reactions - Declined participation on follow-up interview - Age less than 18 years old - Non-English speaking - Electronic health record flagged for research opt out

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Follow-up phone interview
Follow-up phone interview within 7 business days after receiving intravenous chemotherapy

Locations

Country Name City State
United States Cedars-Sinai Medical Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

Cebollero J, LaFollette JA, Walton SM, Adams Curry M. Evaluation of a Pharmacist-Developed, Nurse-Driven Protocol for Management of Parenteral Anticancer Therapy Infusion Reactions in an Ambulatory Infusion Center. J Oncol Pharm Pract. 2023 Jun;29(4):802- — View Citation

Crannage AJ, Hennessey EK, Challen LM, Stevens AM, Berry TM. Implementation of a Discharge Education Program to Improve Transitions of Care for Patients at High Risk of Medication Errors. Ann Pharmacother. 2020 Jun;54(6):561-566. doi: 10.1177/106002801989 — View Citation

Nguyen PAA, Enwere E, Gautreaux S, Lin H, Tverdek F, Lu M, Cao H, Chase J, Roux R. Impact of a pharmacy-driven transitions-of-care program on postdischarge healthcare utilization at a national comprehensive cancer center. Am J Health Syst Pharm. 2018 Sep 15;75(18):1386-1393. doi: 10.2146/ajhp170747. Epub 2018 Jul 31. — View Citation

Patel SD, Nguyen PAA, Bachler M, Atkinson B. Implementation of postdischarge follow-up telephone calls at a comprehensive cancer center. Am J Health Syst Pharm. 2017 Jun 1;74(11 Supplement 2):S42-S46. doi: 10.2146/ajhp160805. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Hospital admission related to chemotherapy within 30-day post treatment Number of hospital admission related to chemotherapy 30 days after receiving the first intravenous chemotherapy
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