- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05776680
The Effects of Multi-Psycho-Oncology Care Courses
August 3, 2023 updated by: National Taiwan University Hospital
The Effects of Multi-Psycho-Oncology Care Courses Through Remote Psychological Support, Emotional Awareness Situation Videos and Empathic Concern Intervention on Physical and Psychological Status, Self-Efficacy and Empathy in Oncology Nurses
When the patient's mood has not yet reached a moderate to high severity level, psychological support is usually provided by the clinical nurses.
However, the result of past research showed that the needs of patients and their caregivers were not satisfied with the psychological level.
Scholars pointed out that it may be related to factors such as excessive clinical workload or insufficient psychological support and care capacity.
In addition, under the influence of COVID-19 in the past two years, medical staff are facing more physical and mental pressure.
Oncology nurses have a heavy workload and are affected by the COVID 19 epidemic, which reflects that nurses need psychological support.
Therefore, this study intends to reduce stress through remote physical and mental support activities, and use the Internet to intervene in guided relaxation and meditation.
Considering the scheduling of clinical nurses, a remote and unstructured course content that does not require continuity will be selected, and then advanced to provide the empathetic care skills of oncology nurses.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
280
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
- Recruiting
- 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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Intervention group
- Inclusion Criteria:
- Over 20 years old (inclusive)
- Oncology nurses currently working in clinical practice
- Exclusion Criteria:
- Those who are unwilling or unable to participate in this course training for a full one- year period.
- Those who have registered for the advanced oncology nursing course organized by the Society in the current year.
Control group
- Inclusion Criteria:
- Over 20 years old (inclusive)
- Oncology nurses currently working in clinical practice
- Those who have registered for the advanced oncology nursing course organized by the Society in the current year
- Exclusion Criteria:
- Those who have participated in multiple oncology psychological care courses, those who are unwilling or unable to participate in the training of distance psychological support courses for a full one-year period.
- Those who participate in the advanced course of oncology nursing are unwilling or unable to participate in the data evaluation of the complete bi-annual time point.
- Those who have participated in this research project.
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: Psychological Support Course
60-minute once or twice a week for 6 months of Initial Remote Psychological Support Course .
|
60-minute once or twice a week for 6 months of Initial Remote Psychological Support Course .
|
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 |
---|---|---|
Physical and Psychological Symptoms Scale
Time Frame: 2 time points: Time 1 (before the psychological support course) ; Time 2 ( 6 months after the psychological support course)
|
Oncology nurses' physical and psychological state were 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).
|
2 time points: Time 1 (before the psychological support course) ; Time 2 ( 6 months after the psychological support course)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self efficacy scale (GSES)
Time Frame: 2 time points: Time 1 (before the psychological support course) ; Time 2 ( 6 months after the psychological support course)
|
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.
|
2 time points: Time 1 (before the psychological support course) ; Time 2 ( 6 months after the psychological support course)
|
Communication ability scale
Time Frame: 2 time points: Time 1 (before the psychological support course) ; Time 2 (6 months after the psychological support 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 psychological support course) ; Time 2 (6 months after the psychological support course)
|
Efferson Empathy Scale
Time Frame: 2 time points: Time 1 (before the psychological support course) ; Time 2 ( 6 months after the psychological support course)
|
Oncology nurses' empathy were measured by Efferson Empathy Scale.
It is a 7 Liker scale(1-7),higher scores means someone have more empathy.
|
2 time points: Time 1 (before the psychological support course) ; Time 2 ( 6 months after the psychological support course)
|
Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being (FACIT-Sp)
Time Frame: 2 time points: Time 1 (before the psychological support course) ; Time 2 ( 6 months after the psychological support course)
|
Oncology nurses' spiritual well-being were measured by FACIT-Sp.It is a 5 Liker scale(0-4),higher scores represent better well-being.
|
2 time points: Time 1 (before the psychological support course) ; Time 2 ( 6 months after the psychological support course)
|
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 (Actual)
August 22, 2022
Primary Completion (Estimated)
October 31, 2023
Study Completion (Estimated)
October 31, 2023
Study Registration Dates
First Submitted
November 3, 2022
First Submitted That Met QC Criteria
March 8, 2023
First Posted (Actual)
March 20, 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
- 202112219RINB
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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