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Clinical Trial Summary

This study is a 2-year qualitative and quantitative mixed method research project and consists of two phases.The study will provide useful clinical data to help us better understand educational needs of immunotherapy for oncology nurses. This ISTC model will lead to further validation of an oncology care training course model designed to better prepare and support cancer patients and their families to existing and new anti-cancer therapies.


Clinical Trial Description

Background: More and more cancer patients are receiving immunotherapy. However, patients and their families are overwhelmingly not fully aware of the side effects of immunotherapy or the related management involved while simultaneously experiencing both financial and spiritual burden. Thus, educating the needs of immunotherapy and the development and planning of immunotherapy-related training courses for oncology nurses are necessary. Purpose: (1) To explore the educational needs for immunotherapy in oncology nurses. (2) To develop and evaluate the effectiveness of "Multi-Immunotherapy Special Training Courses through Digital Media and Workshop" intervention" (short for Immunotherapy Special Training Course (ISTC)" on immunotherapy related care indicators and the feasibility of the ISTC. Method: This study is a 2-year qualitative and quantitative mixed method research project and consists of two phases: (1) The qualitative method will be conducted using phenomenological methods and snowball sampling. In-depth interviews and observations by one researcher will be adopted in this study. The sample size is determined as the number of samples collected until saturated data analysis is achieved. (2) The quantitative method will be conducted as a quasi-experimental research with a two group pretest-posttest. For the experimental group, snowball sampling will be used to recruit participants who are recommended by a cooperative teaching hospital in the North, Central, South and East Districts of Taiwan to participate in the ISTC training. The duration is to last 16 weeks and includes 8 hours of digital media training and 2 days of workshop training. For the control group, convenient sampling will be used to recruit participants attending the "Advanced Oncology Nurse Training Course (AONTC) (during 4 weeks, 8 days)." which will be held by the Taiwan Oncology Nursing Society. Each group will be followed for 3 to 4 months and their outcomes will be assessed at 3 time points: baseline (pre-training course), and 8, 12 weeks after the training course, T0-T2, respectively. Outcomes will be evaluated based on immunotherapy knowledge, self-efficacy of caring responsible for patients undergoing immunotherapy, critical thinking ability, and ability of communication. Additionally, in the experimental group, outcomes will also be evaluated by mini-clinical evaluation exercise, mini-CEX at T2 and learning passport at 16 weeks after training course (T3). Estimated subject number would be 60 for each group. Results would be analyzed mainly by GEE. After obtaining approval from the institutional review board of a medical center in northern Taiwan and getting the required consent, this study will commence. Predicted results: The study will provide useful clinical data to help us better understand educational needs of immunotherapy for oncology nurses. This ISTC model will lead to further validation of an oncology care training course model designed to better prepare and support cancer patients and their families to existing and new anti-cancer therapies. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05750199
Study type Interventional
Source National Taiwan University Hospital
Contact
Status Completed
Phase N/A
Start date April 28, 2021
Completion date October 19, 2022

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