- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07600853
Development and Validation of an E-learning Module on Systemic Anticancer Therapy and Its Effectiveness on the Knowledge Attitude and Practice of Nurses in Administering Systemic Anticancer Agents at a Specialized Cancer Centres in Oman. (SACT -KAP)
Cancer is becoming more common worldwide. In countries like the United States, cases of breast and colorectal cancer have increased in recent years. A similar pattern is seen in Oman, where breast cancer is the most common cancer among women, and colorectal cancer is the most common among men. As more people are diagnosed with cancer, there is a growing need for safe and effective cancer treatment.
One important type of treatment is systemic anticancer therapy (SACT), which includes medications such as chemotherapy, immunotherapy, and targeted therapy. These treatments are powerful and can cause serious side effects if not given correctly. Because of this, nurses who administer these treatments need special knowledge and skills to ensure patient safety.
This study aims to develop an online learning (e-learning) program to help nurses improve their knowledge, skills, and confidence in safely administering systemic anticancer therapy. The study will also evaluate whether this e-learning program is effective compared to routine education.
The study will be conducted in two major cancer care centers in Oman: the National Oncology Centre at Royal Hospital and the Sultan Qaboos Comprehensive Cancer Care and Research Centre. Nurses working in oncology and hematology units in these centers will be invited to participate.
Participants will be divided into two groups. One group will receive access to the e-learning program (intervention group), while the other group will continue with their usual training (control group). The assignment to these groups will be done randomly to ensure fairness.
Before starting the program, all participants will complete a questionnaire to assess their current knowledge, attitude, and practices related to systemic anticancer therapy. They will also provide basic information such as their age, years of experience, and previous training.
The e-learning program will be developed based on the learning needs of nurses and reviewed by experts in oncology to ensure accuracy and quality. Nurses in the intervention group will be given time to complete the online training.
After the training period, all participants (both groups) will complete the same questionnaire again. This will help researchers compare the results before and after the training, as well as between the two groups, to see if the e-learning program made a difference.
The study will also assess how satisfied the nurses are with the e-learning program, as learner satisfaction is important for the success of educational interventions.
Participation in this study is voluntary. All participants will provide written informed consent before joining the study. They will be informed about the purpose of the study, what they need to do, and their right to withdraw at any time without any negative consequences. All information collected will be kept confidential and used only for research purposes.
At the end of the study, nurses in the control group will also be given access to the e-learning program to ensure fairness.
The results of this study are expected to show that the e-learning program improves nurses' knowledge, attitudes, and clinical practices in administering systemic anticancer therapy. This may help improve patient safety and the quality of cancer care in Oman.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Namitha S Sivankutty, Masters of Science in Nursing
- Telefonní číslo: +96879389910
- E-mail: namithasivankutty@sriramachandra.edu.in
Studijní záloha kontaktů
- Jméno: Aida M. Al Kindy, MQM
- Telefonní číslo: +96897655101
- E-mail: a.alkindy@cccrc.gov.om
Studijní místa
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Seeb
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Muscat, Seeb, Omán, 123
- Sultan Qaboos Comprehensive Cancer Care and Research Center - University Medical City
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Kontakt:
- Al Kindy
- Telefonní číslo: 97655101
- E-mail: a.alkindy@cccrc.gov.om
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Nurses who are willing to participate in the study
- Nurses who speaks and understand English.
- Nurses who administer systemic anti-cancer treatment in oncology units.
- Nurses who are administering systemic anticancer treatment to the adult oncology patient through IV piggyback
- Nurses who are willing to attend the orientation meeting getting familiarity with the study purpose and e- learning module.
- Nurses who completed baseline training in systemic anticancer therapy.
Exclusion Criteria:
- Nurses who are not willing to participate in the study
- Nurses who are administering systemic anticancer therapy to the pediatric patients
- Nurses who are administering systemic anticancer therapy to the non-oncology patient.
- Nurses who are not completed baseline training in systemic anticancer therapy.
- Nurses who are pregnant and breast feeding.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Control Group: No E-Learning Intervention
As a participant in the control group, you will not receive the E-learning intervention during the initial phase of the study.
You will continue with the standard institutional training and routine clinical practice provided at the hospital.
Your participation will allow comparison between nurses who receive the intervention and those who follow the existing training system.
At the completion of the study, access to the E-learning module may be provided to you as per institutional approval.
|
Arm Description: As a participant in the control group, you will not receive the E-learning intervention during the initial phase of the study.
You will continue with the standard institutional training and routine clinical practice provided at the hospital.
Your participation will allow comparison between nurses who receive the intervention and those who follow the existing training system.
At the completion of the study, access to the E-learning module may be provided to you as per institutional approval.
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Experimentální: Interventional Arm: Receives E-Learning Modules
The intervention consists of a 20-hour E-learning certification course designed to enhance nurses' knowledge and clinical skills in systemic anti-cancer therapy administration and care. The course curriculum was developed and validated with guidance from oncology experts at the Sultan Qaboos Comprehensive Cancer Care and Research Centre and Sree Ramachandra Institute of Higher Education and Research. The content aligns with recognized international standards, including those from the United States Pharmacopeia (USP <800>), the Oncology Nursing Society Chemotherapy and Immunotherapy Guidelines (2023), the Joint Commission International Standards for Hospitals (8th Edition), and the National Institute for Occupational Safety and Health. |
Arm Description: The intervention consists of a 20-hour E-learning certification course designed to enhance nurses' knowledge and clinical skills in systemic anti-cancer therapy administration and care.
The course curriculum was developed and validated with guidance from oncology experts at the Sultan Qaboos Comprehensive Cancer Care and Research Centre and Sree Ramachandra Institute of Higher Education and Research.
The content aligns with recognized international standards, including those from the United States Pharmacopeia (USP <800>), the Oncology Nursing Society Chemotherapy and Immunotherapy Guidelines (2023), the Joint Commission International Standards for Hospitals (8th Edition), and the National Institute for Occupational Safety and Health.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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1: Knowledge regarding systemic anticancer therapy (SACT) administration
Časové okno: Baseline and post-intervention- (collected within one year)
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Knowledge will be assessed using a 30-item multiple-choice questionnaire developed by the researcher based on the content of the e-learning module for systemic anticancer therapy administration.
The questionnaire was validated by oncology experts.
Total scores range from 0 to 30, with higher scores indicating greater knowledge regarding SACT administration.
Knowledge levels will be categorized as follows: Basic knowledge (0-10), Moderate knowledge (11-20), and High knowledge (21-30).
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Baseline and post-intervention- (collected within one year)
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Primary Outcome Measure 2: Attitude toward safe administration of systemic anticancer therapy (SACT)
Časové okno: Baseline and post-intervention (Within 1 year)
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Attitude will be measured using a validated structured dichotomous questionnaire assessing nurses' attitudes toward the safe administration of systemic anticancer therapy drugs. The tool was developed by a nurse researcher, and formal permission was obtained for its use in the current study. The total attitude score ranges from 0 to 6, with higher scores indicating a more positive attitude toward safe systemic anticancer therapy (SACT) administration. Scores ranging from 0 to 3 indicate a negative attitude toward SACT administration, whereas scores above 3 indicate a positive attitude. Previous study: https://doi.org/10.31557/apjcp.2025.26.9.3331 |
Baseline and post-intervention (Within 1 year)
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Primary Outcome Measure 3: Practice related to systemic anticancer therapy (SACT) administration
Časové okno: Baseline and post-intervention (Within 1 year of data collection)
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Practice will be evaluated using the Oncology Nursing Society Clinical Practicum Checklist, a validated tool designed to assess core nursing practices related to systemic anticancer therapy administration. The checklist consists of 12 items representing key components of safe and effective SACT administration. Each item is scored dichotomously as Yes = 1 point (correct/competent practice) and No = 0 points (incorrect or incomplete practice). Total scores range from 0 to 12, with higher scores indicating greater competence in SACT administration. Practice levels will be categorized as follows: Poor practice (0-4), Moderate practice (5-8), and Good practice (9-12). |
Baseline and post-intervention (Within 1 year of data collection)
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- E learning SACT -KAP Study
- CCCRC-54-2024 (Jiný identifikátor: SQCCCRC IRB)
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