ChemotherapyNCT06664476
Educational Program's Impact on Nurses' Skills in Port-A-Catheter Care for Chemotherapy Patients
A study testing PortCare Professional Training Program in people with Chemotherapy, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this experimental study is to evaluate if an educational intervention can improve nurses' knowledge and practice in caring for patients with implanted Port-A-Catheters among oncology nurses directly involved in chemotherapy care. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Chemotherapy
- What is being tested?
- PortCare Professional Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 15 Nov 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Nurses with at least one year of experience in oncology or chemotherapy units.
- Nurses currently working in the Oncology Care Center or related units that handle Port-A-Catheters.
Who cannot join
- Staff nurses working with experience less than least 6 months.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculy of Nursing Kafr El sheikh University
Cairo, 6850001
Mohammed Elsayed Zaky Principle Investigator, Ph.D, 01000553254, Mohammed.Zaky@cu.edu.eg
About this study
Official title: The Effect of Educational Program on Nurses' Knowledge and Practice Regarding Implanted Port-A-Catheter Care for Patients Undergoing Chemotherapy
The goal of this experimental study is to evaluate if an educational intervention can improve nurses' knowledge and practice in caring for patients with implanted Port-A-Catheters among oncology nurses directly involved in chemotherapy care. The main questions it aims to answer are:
Will the educational program improve nurses' knowledge regarding Port-A-Catheter care? Will the educational program positively impact nurses' practical skills and reduce complications related to Port-A-Catheter management? Researchers will compare pre-intervention and post-intervention performance to see if the educational program leads to better knowledge and practice outcomes.
Read more
Participants will:
Attend a theoretical training session on Port-A-Catheter fundamentals, including its use, benefits, and common complications.
Engage in a practical session, involving demonstrations and supervised practice of Port-A-Catheter care, such as insertion, flushing, and removal.
Be evaluated before the intervention, immediately after, and at 2 weeks post-intervention to assess improvements and retention of knowledge and skills.
Read the detailed description
Cancer is a rapidly growing, invasive, and metastatic disease caused by an accumulation of genetic mutations that lead to the formation of malignant cells. These genetic changes can result from exposure to chemical carcinogens, chronic inflammation, radiation, or a genetic predisposition. Globally, cancer is a significant public health challenge and ranks as the second leading cause of death in the United States. In recent years, the global burden of cancer has surged, with millions of new cases and fatalities each year. In Egypt, the numbers reflect a similar pattern, highlighting the widespread impact of this disease.
Chemotherapy remains the most commonly used treatment for cancer, utilizing chemical agents that target and destroy cancer cells, preventing their growth and spread. Often, chemotherapy is combined with other treatment modalities like surgery or radiation. While chemotherapy can be delivered through various routes, intravenous (IV) administration is the most common. Modern chemotherapy management requires consistent and safe access to the venous system for the delivery of drugs, fluids, and blood products. Due to the damaging effects of repeated venipuncture and long-term chemotherapy on peripheral veins, long-term venous access devices (VADs) have become essential. One of the most frequently used VADs is the Port-A-Catheter system.
A Port-A-Catheter is a medical device that provides direct access to large blood vessels. It consists of a reservoir (or portal) and a catheter, implanted in a surgically created pocket on the chest wall or upper arm. The portal is placed subcutaneously and connects to the catheter with a specialized lock. It can be used for chemotherapy 12 to 24 hours after insertion and typically remains in place for two to six years.
This device significantly reduces the pain and anxiety associated with repeated needle sticks or venous procedures, allowing patients greater freedom and safety in their daily activities. The Port-A-Catheter enables the delivery of chemotherapy agents, blood products, parenteral nutrition, and the collection of blood samples for testing, all contributing to an improved quality of life.
The primary benefits of ports include easier venous access, especially for patients with small or compromised veins, a lower risk of chemotherapy extravasation, and the ability to administer irritating substances. However, Port-A-Catheters are not without risks, which are categorized as early or delayed complications. Early complications may involve incorrect catheter positioning, pneumothorax, hemothorax, thoracic duct injury, or cardiac tamponade. Delayed complications include infections, thrombosis, stenosis, catheter fractures, and migration.
Proper nursing care and maintenance of implanted ports are crucial to keeping them functional and preventing complications. This care includes regular flushing, heparin locking, dressing changes, needle replacements, and scrubbing the access port with antiseptic solutions to minimize contamination risks. Nurses play a pivotal role in maintaining the integrity of the port, preventing failure, and reducing complications related to its use. Effective nursing care requires sharp assessment skills and sound clinical judgment to identify and manage central venous access device (CVAD) complications effectively.
- Conditions
- Chemotherapy
- Being tested
- PortCare Professional Training Program
- Keywords
- Implanted Port-A-Catheter, Oncology Nursing, Chemotherapeutic Management, Nurses' Knowledge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PortCare Professional Training ProgramBehavioural
The intervention is a targeted educational program to enhance oncology nurses' skills in managing Port-A-Catheters for chemotherapy patients. It includes a preparatory phase to assess baseline knowledge and practices, followed by an implementation phase with theoretical and practical training. Theoretical sessions cover device basics and care guidelines, while practical sessions provide hands-on training on procedures like catheter insertion, flushing, and removal. This program aims to improve patient safety, reduce complications, and boost nurses' confidence in Port-A-Catheter care.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | The study group for this research consists of 45 oncology nurses who are actively involved in the care and management of patients with implanted Port-A-Catheters for chemotherapy. These nurses are recruited from the Oncology and Nuclear Medicine Center at Kasr Elini hospital, which includes outpatient clinics. The nurses in this study play a critical role in handling long-term venous access devices, particularly Port-A-Catheters, which are essential for the administration of chemotherapy and other related treatments. Receives: Behavioral: PortCare Professional Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nurses' knowledge regarding implanted port-A-Catheter care for patients undergoing Chemotherapy "Structured Interview Questionnaire
This part will be concerning with assessing nurses' knowledge about implanted port -A Catheter care for patients undergoing chemotherapy. It will include "thirty-eight" multiple choice questions; which will cover the following: "ten" questions are in relation to "General Nurses' knowledge about implanted port -A-Catheter", fourteen questions are about "Catheter connection and disconnection nursing care", "three" questions concerning "Catheter exit site care", "two" questions regarding "Port-A Catheter removal, "one" question about "patient documentation" and "eight" questions related to "Port-A-Catheter infection and complications".
Measured: 2 weeks
Secondary outcomes (1)
Oncology Nurses' Practices regarding Implanted Port-A-Catheter Care for Patients undergoing Chemotherapy Observational Checklist
Used to assess nurse's practice for port catheter (Accessing/ De-accessing, flushing, and removal of the noncoring safety needle of implanted port catheter).
Each item will be checked as: "Done correctly" took "One" score and "Not done" or "Incorrectly done" had "Zero", with a total score of "117" grades. The total nurses' practices score will be calculated and transferred to percentage reflecting the levels of practices as follows: "Less than 60%" are considered "Poor practice level" "From 60% -75 %" reflects "Fair practice level" "More than 75%" denotes "Good practice level"
Measured: 2 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start1 Oct 2024
- Primary completion29 Oct 2024 (estimated)
- Study completion15 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ChemotherapyStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Kafrelsheikh University
- Responsible party
- Principal investigator, Mohammed Elsayed Zaky, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06664476
- Sponsor's protocol ID
- Nurses' Knowledge and Practice
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 29 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mohamed, S., Talaat, E., & Falts, S. (2019). Assess nurses' performance regarding care of patient with implanted port undergoing chemotherapy. Egyptian Journal of Health C Alzuhairy, B. I. J., Al Zobair, A. A., & Al-Faqe, F. M. M. (2021). Complications of Port-A-Cath use for chemotherapy, drugs, and fluid administration in Mosul city. Archivos Venezolanos de Farmacología y Terapéutica, 40(4), 377-383
Rossi F, Noren H, Jove R, Beljanski V, Grinnemo KH. Differences and similarities between cancer and somatic stem cells: therapeutic implications. Stem Cell Res Ther. 2020 Nov 18;11(1):489. doi: 10.1186/s13287-020-02018-6.
PubMed 33208173
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Educational Program on Nurses' Knowledge and Practice Regarding Implanted Port-A-Catheter Care for Patients Undergoing Chemotherapy
- ClinicalTrials.gov ID
- NCT06664476
- Acronym / sponsor ID
- Nurses' Knowledge and Practice
- Conditions
- Chemotherapy
- Keywords
- Implanted Port-A-Catheter, Oncology Nursing, Chemotherapeutic Management, Nurses' Knowledge
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Kafrelsheikh University
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 29 Oct 2024 (estimated)
- Study completion
- 15 Nov 2024 (estimated)
- First posted
- 29 Oct 2024 (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 goal of this experimental study is to evaluate if an educational intervention can improve nurses' knowledge and practice in caring for patients with implanted Port-A-Catheters among oncology nurses directly involved in chemotherapy care. The main questions it aims to answer are:
Will the educational program improve nurses' knowledge regarding Port-A-Catheter care? Will the educational program positively impact nurses' practical skills and reduce complications related to Port-A-Catheter management? Researchers will compare pre-intervention and post-intervention performance to see if the educational program leads to better knowledge and practice outcomes.
Participants will:
Attend a theoretical training session on Port-A-Catheter fundamentals, including its use, benefits, and common complications.
Engage in a practical session, involving demonstrations and supervised practice of Port-A-Catheter care, such as insertion, flushing, and removal.
Be evaluated before the intervention, immediately after, and at 2 weeks post-intervention to assess improvements and retention of knowledge and skills.
Detailed description
Cancer is a rapidly growing, invasive, and metastatic disease caused by an accumulation of genetic mutations that lead to the formation of malignant cells. These genetic changes can result from exposure to chemical carcinogens, chronic inflammation, radiation, or a genetic predisposition. Globally, cancer is a significant public health challenge and ranks as the second leading cause of death in the United States. In recent years, the global burden of cancer has surged, with millions of new cases and fatalities each year. In Egypt, the numbers reflect a similar pattern, highlighting the widespread impact of this disease.
Chemotherapy remains the most commonly used treatment for cancer, utilizing chemical agents that target and destroy cancer cells, preventing their growth and spread. Often, chemotherapy is combined with other treatment modalities like surgery or radiation. While chemotherapy can be delivered through various routes, intravenous (IV) administration is the most common. Modern chemotherapy management requires consistent and safe access to the venous system for the delivery of drugs, fluids, and blood products. Due to the damaging effects of repeated venipuncture and long-term chemotherapy on peripheral veins, long-term venous access devices (VADs) have become essential. One of the most frequently used VADs is the Port-A-Catheter system.
A Port-A-Catheter is a medical device that provides direct access to large blood vessels. It consists of a reservoir (or portal) and a catheter, implanted in a surgically created pocket on the chest wall or upper arm. The portal is placed subcutaneously and connects to the catheter with a specialized lock. It can be used for chemotherapy 12 to 24 hours after insertion and typically remains in place for two to six years.
This device significantly reduces the pain and anxiety associated with repeated needle sticks or venous procedures, allowing patients greater freedom and safety in their daily activities. The Port-A-Catheter enables the delivery of chemotherapy agents, blood products, parenteral nutrition, and the collection of blood samples for testing, all contributing to an improved quality of life.
The primary benefits of ports include easier venous access, especially for patients with small or compromised veins, a lower risk of chemotherapy extravasation, and the ability to administer irritating substances. However, Port-A-Catheters are not without risks, which are categorized as early or delayed complications. Early complications may involve incorrect catheter positioning, pneumothorax, hemothorax, thoracic duct injury, or cardiac tamponade. Delayed complications include infections, thrombosis, stenosis, catheter fractures, and migration.
Proper nursing care and maintenance of implanted ports are crucial to keeping them functional and preventing complications. This care includes regular flushing, heparin locking, dressing changes, needle replacements, and scrubbing the access port with antiseptic solutions to minimize contamination risks. Nurses play a pivotal role in maintaining the integrity of the port, preventing failure, and reducing complications related to its use. Effective nursing care requires sharp assessment skills and sound clinical judgment to identify and manage central venous access device (CVAD) complications effectively.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: PortCare Professional Training ProgramThe study group for this research consists of 45 oncology nurses who are actively involved in the care and management of patients with implanted Port-A-Catheters for chemotherapy. These nurses are recruited from the Oncology and Nuclear Medicine Center at Kasr Elini hospital, which includes outpatient clinics. The nurses in this study play a critical role in handling long-term venous access devices, particularly Port-A-Catheters, which are essential for the administration of chemotherapy and other related treatments. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Nurses with at least one year of experience in oncology or chemotherapy units.
- Nurses currently working in the Oncology Care Center or related units that handle Port-A-Catheters.
Key exclusion criteria (1 listed)
- Staff nurses working with experience less than least 6 months.
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 |
|---|---|---|
| PortCare Professional Training ProgramThe intervention is a targeted educational program to enhance oncology nurses' skills in managing Port-A-Catheters for chemotherapy patients. It includes a preparatory phase to assess baseline knowledge and practices, followed by an implementation phase with theoretical and practical training. Theoretical sessions cover device basics and care guidelines, while practical sessions provide hands-on training on procedures like catheter insertion, flushing, and removal. This program aims to improve patient safety, reduce complications, and boost nurses' confidence in Port-A-Catheter care. | Behavioural | Study group |
Primary outcome
Nurses' knowledge regarding implanted port-A-Catheter care for patients undergoing Chemotherapy "Structured Interview Questionnaire
Time frame: 2 weeks
This part will be concerning with assessing nurses' knowledge about implanted port -A Catheter care for patients undergoing chemotherapy. It will include "thirty-eight" multiple choice questions; which will cover the following: "ten" questions are in relation to "General Nurses' knowledge about implanted port -A-Catheter", fourteen questions are about "Catheter connection and disconnection nursing care", "three" questions concerning "Catheter exit site care", "two" questions regarding "Port-A Catheter removal, "one" question about "patient documentation" and "eight" questions related to "Port-A-Catheter infection and complications".
1 secondary outcome
Oncology Nurses' Practices regarding Implanted Port-A-Catheter Care for Patients undergoing Chemotherapy Observational Checklist
Time frame: 2 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Results publicationMohamed, S., Talaat, E., & Falts, S. (2019). Assess nurses' performance regarding care of patient with implanted port undergoing chemotherapy. Egyptian Journal of Health C Alzuhairy, B. I. J., Al Zobair, A. A., & Al-Faqe, F. M. M. (2021). Complications of Port-A-Cath use for chemotherapy, drugs, and fluid administration in Mosul city. Archivos Venezolanos de Farmacología y Terapéutica, 40(4), 377-383
- Results publication: PubMed 33208173Rossi F, Noren H, Jove R, Beljanski V, Grinnemo KH. Differences and similarities between cancer and somatic stem cells: therapeutic implications. Stem Cell Res Ther. 2020 Nov 18;11(1):489. doi: 10.1186/s13287-020-02018-6.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PortCare Professional Training Program in people with Chemotherapy, run by Cairo University at 1 site in Egypt.
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 2 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 29 Oct 2024. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammed ElSayed Zaky Principle Investigator, Ph.D (01000553254, Mohammed.Zaky@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nurses' knowledge regarding implanted port-A-Catheter care for patients undergoing Chemotherapy "Structured Interview Questionnaire (time frame: 2 weeks). 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 NCT06664476, which also lists 2 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 29 Oct 2024.