- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05977504
The Effectiveness of "Multi-Psychological Empowerment" Courses
August 3, 2023 updated by: National Taiwan University Hospital
The Effectiveness of "Multi-Psychological Empowerment" Courses Through Remote, Digital Media, Workshop Intervention for Oncology Nurses on Physical and Psychological Status, Self-Efficacy and Communication Ability
In the first-year project of this study, oncology nurses have reported experiencing massive stress, insufficient communication ability, and the need for communication-related training.
70% of them had moderate or higher severity of workload, fatigue, and psychological distress (at the measure point) before being provided with Basic Remote Psychological Support Course (BRPSC).
A month after BRPSC, some oncology nurses have indicated/affirmed the benefits of undergoing the comprehensive psycho oncology education training courses.
Thus, the second- and third-year continuation projects are focused on the development and delivery of Multi-Psychological Empowerment Courses (MPEC) for oncology nurses
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
100
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 Contact
- Name: Yun Hsiang Lee, Phd
- Phone Number: 88424 886 2 23123456
- Email: yhlee338@ntu.edu.tw
Study Locations
-
-
-
Taipei, Taiwan, 802
- National Taiwan University Hospital
-
Contact:
- Yun Hsiang Lee, Phd
- Phone Number: 88424 886 2 23123456
- Email: yhlee338@ntu.edu.tw
-
-
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
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Intervention group
- Inclusion Criteria:
- Over 20 years old (inclusive)
- Oncology nurses currently working in clinical practice
- At least receiving one course related to oncology nurse training, such as chemotherapy for nursing staff or oncology advanced training courses.
- Exclusion Criteria:
- Those who are unwilling or unable to participate in this course training for a full one- year period.
Control group Oncology nurses who do not need to be recruited for the comparison group will be students who participated in the remote psychological support course of the first year project effective comparison groups.
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: Multi-Psychological Empowerment Courses
9 times online course and 3-days workshop for 6 months .
|
9 times online course and 3-days workshop for 6 months of psychological Empowerment Courses.
|
|
No Intervention: Control group
Participants in control group will receive usual course.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The change in Physical and Psychological Symptoms
Time Frame: 5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks;Time 4:12th weeks;Time 5(back to work 1 month)
|
The change in oncology nurses' physical and psychological state will be measured by physical and psychological state survey.
It use Numerical Rating Scale(VRS) 0-10.
It is a 11 Point Likert Scale (e. g. 0 is no pain; 10 is unbearable pain).
|
5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks;Time 4:12th weeks;Time 5(back to work 1 month)
|
|
The change in Workload
Time Frame: 5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks;Time 4:12th weeks;Time 5(back to work 1 month)
|
The change in oncology nurses' workload will be measured by the self-designed scale using VRS (Numerical Rating Scale).
It measures the subjective perception of oncology nurses about their workload in the past week, with scores ranging from 0 to 10.The higher the score, the greater the workload of the oncology nurses.
|
5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks;Time 4:12th weeks;Time 5(back to work 1 month)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self efficacy scale (GSES)
Time Frame: 5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks;Time 4:12th weeks;Time 5(back to work 1 month)
|
Oncology nurses' self-efficacy were measured by self efficacy scale.
There are 10 questions about the level of confidence in these situations.
It's a 4 point (1-4),higher the score means the more confident you have.
There is also 11 point (0-10) scale that higher the score means the more confident you are in caring for patients.
|
5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks;Time 4:12th weeks;Time 5(back to work 1 month)
|
|
Communication ability scale
Time Frame: 5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks;Time 4:12th weeks;Time 5(back to work 1 month)
|
Oncology nurses' communication skills were measured by communication ability scale.It is a 5 Liker scale(1-5),higher scores represent better communication skills.
|
5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks;Time 4:12th weeks;Time 5(back to work 1 month)
|
|
Efferson Empathy Scale
Time Frame: 5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks;Time 4:12th weeks;Time 5(back to work 1 month)
|
Oncology nurses' empathy were measured by Efferson Empathy Scale.
It is a 7 Liker scale(1-7),higher scores means someone have more empathy.
|
5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks;Time 4:12th weeks;Time 5(back to work 1 month)
|
|
Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)
Time Frame: 5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks;Time 4:12th weeks;Time 5(back to work 1 month)
|
Oncology nurses' spiritual well-being were measured by FACIT-Sp.It is a 5 Liker scale(0-4),higher scores represent better well-being.
|
5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks;Time 4:12th weeks;Time 5(back to work 1 month)
|
|
Burnout Inventory survey
Time Frame: 5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks;Time 4:12th weeks;Time 5(back to work 1 month)
|
Oncology nurses' burnout will be measured by Burnout Inventory survey.It is a 7 Liker scale(0-6),higher scores represent high level burnout .
|
5 time points: Time 1 (before the course) ; after the course starts, Time 2: 4th weeks ; Time3: 8th weeks;Time 4:12th weeks;Time 5(back to work 1 month)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 (Estimated)
August 1, 2023
Primary Completion (Estimated)
April 30, 2024
Study Completion (Estimated)
July 31, 2024
Study Registration Dates
First Submitted
July 3, 2023
First Submitted That Met QC Criteria
July 26, 2023
First Posted (Actual)
August 4, 2023
Study Record Updates
Last Update Posted (Actual)
August 7, 2023
Last Update Submitted That Met QC Criteria
August 3, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202302085RINC
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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