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

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05750199
Collaborator
(none)
120
1
2
24
5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: Immunotherapy Special Training Course (ISTC)
  • Other: Advanced Oncology Nurse Training Course (AONTC)
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Apr 28, 2021
Actual Primary Completion Date :
Feb 15, 2023
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Educational needs [1 time points:first time is before the training course]

    Oncology nurses' educational needs for immunotherapy will be assesed qualitative method.

Secondary Outcome Measures

  1. Communication ability scale [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. Self efficacy scale [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.

  3. Critical Thinking test [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Taipei Taiwan 802

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05750199
Other Study ID Numbers:
  • 201912255RINC
First Posted:
Mar 1, 2023
Last Update Posted:
Mar 1, 2023
Last Verified:
Dec 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 1, 2023