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

August 15, 2023 updated by: National Taiwan University Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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 Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 802
        • National Taiwan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Immunotherapy Special Training Course (ISTC)
16 weeks and includes 8 hours of digital media training and 2 days of workshop training.
Other: Immunotherapy Special Training Course (ISTC)
16 weeks and includes 8 hours of digital media training and 2 days of workshop training.
Experimental: Advanced Oncology Nurse Training Course (AONTC)
4 weeks and includes 8 days of Advanced Oncology Nurse Training Course.
Other: Advanced Oncology Nurse Training Course (AONTC)
4 weeks and includes 8 days of Advanced Oncology Nurse Training Course

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Educational needs
Time Frame: 1 time points:first time is before the training course
Oncology nurses' educational needs for immunotherapy will be assesed qualitative method.
1 time points:first time is before the training course

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Communication ability scale
Time Frame: 2 time points: Time 1 (before the training course) ; Time 2 (16 weeks after the training course)
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)
Self efficacy scale
Time Frame: 2 time points: Time 1 (before the training course) ; Time 2 (16 weeks after the training course)
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)
Critical Thinking test
Time Frame: 2 time points: Time 1 (before the training course) ; Time 2 (16 weeks after the training course)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2021

Primary Completion (Actual)

November 23, 2021

Study Completion (Actual)

October 19, 2022

Study Registration Dates

First Submitted

January 6, 2022

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 15, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201912255RINC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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