CancerNCT05776680
The Effects of Multi-Psycho-Oncology Care Courses
A study testing Psychological support in people with Cancer and Psychological, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer, Psychological, Oncology
- What is being tested?
- Psychological support
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Aug 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
Who cannot join
- 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
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
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 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.
- Conditions
- Cancer, Psychological, Oncology, Empathy
- Being tested
- Psychological support
- Keywords
- cancer, Oncology nurse, Psychological support, Empathy, Training course
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological supportOther
60-minute once or twice a week for 6 months of Initial Remote Psychological Support Course .
| Study group | Role | What they receive |
|---|---|---|
| Psychological Support Course | Experimental | 60-minute once or twice a week for 6 months of Initial Remote Psychological Support Course . Receives: Other: Psychological support |
| 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.
Physical and Psychological Symptoms Scale
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).
Measured: 2 time points: Time 1 (before the psychological support course) ; Time 2 ( 6 months after the psychological support course)
Secondary outcomes (4)
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: 2 time points: Time 1 (before the psychological support course) ; Time 2 ( 6 months after the psychological support course)
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: 2 time points: Time 1 (before the psychological support course) ; Time 2 (6 months after the psychological support course)
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: 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）
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: 2 time points: Time 1 (before the psychological support course) ; Time 2 ( 6 months after the psychological support course)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start22 Aug 2022
- Primary completion31 Oct 2023
- Study completion31 Dec 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
- 280 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
- NCT05776680
- Sponsor's protocol ID
- 202112219RINB
- Status last verified
- Nov 2024
- First submitted
- 3 Nov 2022
- Last updated
- 6 Nov 2024
- 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 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05776680
- Acronym / sponsor ID
- 202112219RINB
- Conditions
- Cancer, Psychological, Oncology, Empathy
- Keywords
- cancer, Oncology nurse, Psychological support, Empathy, Training course
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 22 Aug 2022 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Mar 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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Psychological Support Course | Experimental | Other: Psychological support60-minute once or twice a week for 6 months of Initial Remote Psychological Support Course . |
| 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 (5 listed)
- Over 20 years old (inclusive)
- Oncology nurses currently working in clinical practice
- 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
Key exclusion criteria (6 listed)
- 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
- 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.
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 |
|---|---|---|
| Psychological support60-minute once or twice a week for 6 months of Initial Remote Psychological Support Course . | Other | Psychological Support Course |
Primary outcome
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).
4 secondary outcomes
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)
Communication ability scale
Time frame: 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)
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological support in people with Cancer and Psychological, 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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 6 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
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)). 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 6 Nov 2024.