The Effectiveness of "Multi-Immunotherapy Special Training Courses Through Digital Media and Workshop" Intervention for Oncology Nurses: Exploration of Educational Needs, Curriculum Planning, Implementation and Evaluation

Oncology Clinical Trial

Official title:

The Effectiveness of "Multi-Immunotherapy Special Training Courses Through Digital Media and Workshop" Intervention for Oncology Nurses: Exploration of Educational Needs, Curriculum Planning, Implementation and Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05750199
• Other study ID #: 201912255RINC
• Status: Completed
• Phase: N/A
• Start date: April 28, 2021
• Est. completion date: October 19, 2022

Study information

• Verified date: August 2023
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: October 19, 2022
• Est. primary completion date: November 23, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Over 20 years old (inclusive).

2. Nurses or case managers who have completed the training of oncology nursing courses in their hospitals.

3. Caring experiences of cancer patients who undergoing immunotherapy.

4. The working experience of the oncology unit is at least 1 years.

Exclusion Criteria:

1. Those who are unwilling or unable to participate in the full four-month course training.

Related Conditions & MeSH terms

• Education
• Neoplasms
• Oncology

Intervention

Other:
• Immunotherapy Special Training Course (ISTC)
16 weeks and includes 8 hours of digital media training and 2 days of workshop training.
• Advanced Oncology Nurse Training Course (AONTC)
4 weeks and includes 8 days of Advanced Oncology Nurse Training Course

Locations

Country	Name	City	State
Taiwan	National Taiwan University	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Educational needs	Oncology nurses' educational needs for immunotherapy will be assesed qualitative method.	1 time points:first time is before the training course
Secondary	Communication ability scale	Oncology nurses' communication skills were measured by communication ability scale.It is a 5 Liker scale(1-5),higher scores represent better communication skills	2 time points: Time 1 (before the training course) ; Time 2 (16 weeks after the training course)
Secondary	Self efficacy scale	Oncology nurses' self efficacy will measure by Self efficacy scale.It is a 11 point (0-10) scale.The higher the score, the more confident you are in caring for immunotherapy patients or their families.	2 time points: Time 1 (before the training course) ; Time 2 (16 weeks after the training course)
Secondary	Critical Thinking test	Effects of oncology nurses received immunization course will measure by Critical Thinking test .It is a 6 Liker scale (1-6) ,the higher score indicates that the participant the better the ability to think critically.	2 time points: Time 1 (before the training course) ; Time 2 (16 weeks after the training course)