CancerNCT05977504
The Effectiveness of "Multi-Psychological Empowerment" Courses
A study testing Multi-Psychological Empowerment Courses in people with Cancer and Oncology, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Oncology, Psychological
- What is being tested?
- Multi-Psychological Empowerment Courses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2023to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
National Taiwan University Hospital
Taipei, 802
Yun Hsiang Lee, PhD, 886 2 23123456 ext. 88424, yhlee338@ntu.edu.tw
About this study
Official title: 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
- Conditions
- Cancer, Oncology, Psychological, Self Efficacy, Communication
- Being tested
- Multi-Psychological Empowerment Courses
- Keywords
- Training course, Oncology nurse, Psychological support, Self-efficacy
- Medical subject headings
- Neoplasms, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Psychological Empowerment CoursesOther
9 times online course and 3-days workshop for 6 months of psychological Empowerment Courses.
| Study group | Role | What they receive |
|---|---|---|
| Multi-Psychological Empowerment Courses | Experimental | 9 times online course and 3-days workshop for 6 months . Receives: Other: Multi-Psychological Empowerment Courses |
| Control group | No intervention | Participants in control group will receive usual course. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Physical and Psychological Symptoms
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).
Measured: 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
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.
Measured: 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 outcomes (5)
Self efficacy scale (GSES)
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.
Measured: 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
Oncology nurses' communication skills were measured by communication ability scale.It is a 5 Liker scale(1-5),higher scores represent better communication skills.
Measured: 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
Oncology nurses' empathy were measured by Efferson Empathy Scale. It is a 7 Liker scale(1-7),higher scores means someone have more empathy.
Measured: 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）
Oncology nurses' spiritual well-being were measured by FACIT-Sp.It is a 5 Liker scale(0-4),higher scores represent better well-being.
Measured: 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
Oncology nurses' burnout will be measured by Burnout Inventory survey.It is a 7 Liker scale(0-6),higher scores represent high level burnout .
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start1 Aug 2023 (estimated)
- Primary completion30 Apr 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977504
- Sponsor's protocol ID
- 202302085RINC
- Status last verified
- Aug 2023
- First submitted
- 3 Jul 2023
- Last updated
- 7 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05977504
- Acronym / sponsor ID
- 202302085RINC
- Conditions
- Cancer, Oncology, Psychological, Self Efficacy, Communication
- Keywords
- Training course, Oncology nurse, Psychological support, Self-efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-Psychological Empowerment Courses | Experimental | Other: Multi-Psychological Empowerment Courses9 times online course and 3-days workshop for 6 months . |
| Control group | No intervention | –Participants in control group will receive usual course. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-Psychological Empowerment Courses9 times online course and 3-days workshop for 6 months of psychological Empowerment Courses. | Other | Multi-Psychological Empowerment Courses |
Primary outcome
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).
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 secondary outcomes
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Psychological Empowerment Courses in people with Cancer and Oncology, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yun Hsiang Lee, PhD (886 2 23123456 ext. 88424, yhlee338@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2023.