Malignant Solid NeoplasmNCT04122118
Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center for Patients With Solid Tumor
A study testing Medical Chart Review, Educational Intervention and Survey Administration in people with Malignant Solid Neoplasm, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Malignant Solid Neoplasm
- What is being tested?
- Medical Chart Review, Educational Intervention and Survey Administration
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2019to 5 Mar 2021
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Solid tumor diagnosis
- Starting day 1 of new antineoplastic infusion
- English speaking (and/or English-speaking primary caregiver/proxy)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center
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.
Read the detailed description
PRIMARY OBJECTIVE:
- To demonstrate the effectiveness of a clinical oncology pharmacist in the outpatient infusion center through education, and the identification and correction of medication related problem (MRP)s.
SECONDARY OBJECTIVE:
- To evaluate overall patient and staff satisfaction with the added clinical oncology pharmacy education.
EXPLORATORY OBJECTIVE:
- Estimate the cost avoidance utilizing the pharmacy services provided in the prospective trial.
OUTLINE:
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.
After completion of study, patients are followed up periodically.
- Conditions
- Malignant Solid Neoplasm
- Being tested
- Medical Chart Review, Educational Intervention, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical Chart ReviewOther
Also called Chart Review
Review of medical chart
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Educational
Receive pharmacist-led education
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Medical Chart Review; Other: Educational Intervention; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 1 year
Secondary outcomes (1)
Patient and provider satisfaction with the pharmacist-led education
The survey results will help determine the need for a clinical oncology pharmacist in the outpatient infusion center. Satisfaction will be assessed using a Likert-scale survey. Scale ranges from 1 (strongly disagree) to 5 (strongly agree).
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start25 Sep 2019
- Primary completion5 Mar 2021
- Study completion5 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gloria Espinosa, PharmD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122118
- Sponsor's protocol ID
- 19D.411
- Other IDs
- JT 13521
- Status last verified
- Apr 2025
- First submitted
- 7 Oct 2019
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacist-led Transitions of Care in the Outpatient Oncology Infusion Center
- ClinicalTrials.gov ID
- NCT04122118
- Acronym / sponsor ID
- 19D.411
- Conditions
- Malignant Solid Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 5 Mar 2021 (actual)
- Study completion
- 5 Mar 2021 (actual)
- First posted
- 10 Oct 2019 (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.
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.
Detailed description
PRIMARY OBJECTIVE:
- To demonstrate the effectiveness of a clinical oncology pharmacist in the outpatient infusion center through education, and the identification and correction of medication related problem (MRP)s.
SECONDARY OBJECTIVE:
- To evaluate overall patient and staff satisfaction with the added clinical oncology pharmacy education.
EXPLORATORY OBJECTIVE:
- Estimate the cost avoidance utilizing the pharmacy services provided in the prospective trial.
OUTLINE:
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.
After completion of study, patients are followed up periodically.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hearth services research (pharmacist-led education) | Experimental | Other: Medical Chart Review, Other: Educational Intervention, Other: Survey AdministrationPHASE 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Solid tumor diagnosis
- Starting day 1 of new antineoplastic infusion
- English speaking (and/or English-speaking primary caregiver/proxy)
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| Medical Chart ReviewAlso: Chart ReviewReview of medical chart | Other | Hearth services research (pharmacist-led education) |
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, EducationalReceive pharmacist-led education | Other | Hearth services research (pharmacist-led education) |
| Survey AdministrationAncillary studies | Other | Hearth services research (pharmacist-led education) |
Primary outcome
Number of medical related problem (MRP)s identified by the pharmacist through retrospective chart reviews (Phase I)
Time frame: Up to 1 year
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.
Percent of MRPs corrected as a result of the clinical oncology pharmacist services (Phase II)
Time frame: Up to 1 year
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.
1 secondary outcome
Patient and provider satisfaction with the pharmacist-led education
Time frame: Up to 1 year
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 29 Apr 2025.
- 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.
Gloria Espinosa, PharmD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical Chart Review, Educational Intervention and Survey Administration in people with Malignant Solid Neoplasm, run by Thomas Jefferson University 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 3 inclusion and 2 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 29 Apr 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?
Number of medical related problem (MRP)s identified by the pharmacist through retrospective chart reviews (Phase I) (time frame: Up to 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2025.