- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05965206
Implementation of a Pharmacist-Based, Post-Chemotherapy Follow-up Clinic
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.
Study Overview
Detailed 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Cedars-Sinai Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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 Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Intervention group
Participants receive a follow-up phone call from a pharmacist approximately 7 business days after receiving intravenous chemotherapy infusion
|
Follow-up phone interview within 7 business days after receiving intravenous chemotherapy
Other Names:
|
|
Control group
Participants do not receive a follow-up phone call from a pharmacist after receiving intravenous chemotherapy infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospital admission related to chemotherapy within 30-day post treatment
Time Frame: 30 days after receiving the first intravenous chemotherapy
|
Number of hospital admission related to chemotherapy
|
30 days after receiving the first intravenous chemotherapy
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Suwicha Limvorasak, PharmD, Cedars-Sinai Medical Center
Publications and helpful links
General Publications
- 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.
- 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.
- 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):802-809. doi: 10.1177/10781552221079855. Epub 2022 Feb 14.
- 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: 10.1177/1060028019896377. Epub 2019 Dec 21.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- Study00002683
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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