CancerNCT05965206
Implementation of a Pharmacist-Based, Post-Chemotherapy Follow-up Clinic
An observational study of Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Follow-up phone interview
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2024to 30 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult cancer patients who initiated treatment with intravenous chemotherapy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- Follow-up phone interview
- Keywords
- Pharmacist, Follow up clinic
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follow-up phone interviewBehavioural
Also called Follow-up call
Follow-up phone interview within 7 business days after receiving intravenous chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Participants receive a follow-up phone call from a pharmacist approximately 7 business days after receiving intravenous chemotherapy infusion Receives: Behavioral: Follow-up phone interview | |
| Control group | Participants do not receive a follow-up phone call from a pharmacist after receiving intravenous chemotherapy infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admission related to chemotherapy within 30-day post treatment
Number of hospital admission related to chemotherapy
Measured: 30 days after receiving the first intravenous chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start20 Jul 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Cedars-Sinai Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suwicha Limvorasak, Cedars-Sinai Medical Center
- Investigators
- Suwicha Limvorasak, PharmD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05965206
- Sponsor's protocol ID
- Study00002683
- Status last verified
- May 2025
- First submitted
- 20 Jul 2023
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28506976Nguyen 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.
PubMed 30065061Cebollero 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.
PubMed 35164607Crannage 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.
PubMed 31868004
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Pharmacist-Based, Post-Chemotherapy Follow-up Clinic
- ClinicalTrials.gov ID
- NCT05965206
- Acronym / sponsor ID
- Study00002683
- Conditions
- Cancer
- Keywords
- Pharmacist, Follow up clinic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | – | Behavioral: Follow-up phone interviewParticipants receive a follow-up phone call from a pharmacist approximately 7 business days after receiving intravenous chemotherapy infusion |
| Control group | – | –Participants do not receive a follow-up phone call from a pharmacist after receiving intravenous chemotherapy infusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult cancer patients who initiated treatment with intravenous chemotherapy
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follow-up phone interviewAlso: Follow-up callFollow-up phone interview within 7 business days after receiving intravenous chemotherapy | Behavioural | Intervention group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Background: PubMed 28506976Patel 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.
- Background: PubMed 30065061Nguyen 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.
- Results publication: PubMed 35164607Cebollero 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.
- Results publication: PubMed 31868004Crannage 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suwicha Limvorasak, PharmD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Cedars-Sinai Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital admission related to chemotherapy within 30-day post treatment (time frame: 30 days after receiving the first intravenous chemotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05965206, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.