End-Of-LifeNCT05888480
A Culturally Specific End-of-life Communication Skills Training
A study testing The end-of-life communication skills training and Routine training activity in people with End-Of-Life, run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
The goal of this clinical trial is to evaluate the effectiveness of culturally specific end-of-life communication skills training (CST) among Chinese oncology nurses. The main question it aims to answer is: What is the effectiveness of culturally specific end-of-life CST among Chinese oncology nurses? Participants… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- End-Of-Life
- What is being tested?
- The end-of-life communication skills training and Routine training activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Registered nurses who work with advanced cancer patients in hospital settings
- Consent to participate in the study
Who cannot join
- Nurses working temporarily in the two hospitals as scholars or trainees from other hospitals
- Specialized nurses in palliative care
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310000
Weilin Chen, Master, 86-15715792337, wei-lin.chen@connect.polyu.hk
About this study
Official title: Effects of a Culturally Specific End-of-life Communication Skills Training for Chinese Oncology Nurses
The goal of this clinical trial is to evaluate the effectiveness of culturally specific end-of-life communication skills training (CST) among Chinese oncology nurses.
The main question it aims to answer is: What is the effectiveness of culturally specific end-of-life CST among Chinese oncology nurses? Participants will receive an 8-week communication skills training. Researchers will compare the intervention group and the wait-list group to see if skills, self-efficacy, and outcome expectancy beliefs will be improved.
Read the detailed description
Objectives: The study aims to evaluate the effectiveness of culturally specific end-of-life CST among Chinese oncology nurses.
Design and participants: It is designed as a single-blind, pre-post randomized controlled trial (RCT). Registered nurses who work with advanced cancer patients in hospital settings will be recruited. The participants will be randomly assigned to either the intervention group (IG) or the control group (CG). The IG will receive the end-of-life CST between the two measurement points, and the CG will be a waitlist group and receive the training after the end of data collection.
Data analysis: Demographic information about the participants will be summarised in descriptive statistics. Independent t-tests and chi-square tests are used to investigate the comparability of groups in terms of the demographics generated by randomization. The primary and secondary outcome variables will be examined using covariate-adjusted linear mixed models. This approach enables the consideration of missing data. For non-repeated continuous measurements, ordinary linear regression and logistic models will be adopted. The intention-to-treat (ITT) analysis and post hoc analyses of contaminated data will be performed.
Expected results: Nurses' skills, self-efficacy, and outcome expectancy beliefs will improve after the CST.
- Conditions
- End-Of-Life
- Being tested
- The end-of-life communication skills training, Routine training activity
- Keywords
- Communication, Nurse, Terminally ill
- Medical subject headings
- Death, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The end-of-life communication skills trainingOther
Training methods include lectures, video demonstrations, and simulation in small groups (4-5 trainees per group with multidisciplinary roles). Written and audiovisual learning materials will be offered. Each session will be 150 minutes, including lectures and video demonstration (90 min/session) and simulation and feedback (60 min/session). One session will be conducted in two weeks. Totally there will be four sessions completed in 8 weeks.
Routine training activityOther
Routine training activities arranged by relevant departments in hospitals
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (IG) | Experimental | The IG will receive the end-of-life CST between the two measurement points Receives: Other: The end-of-life communication skills training |
| Control group (CG) | Other | The CG will be a waitlist group and receive the training after the end of data collection. Receives: Other: Routine training activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Skills at 3 months
Measured by Nurses' Clinic Communication Competency Scale, a 58-item self-reported scale which measures six dimensions. A 5-point Likert scale from (1) very poor to (5) very good is used. Higher scores mean a better outcome.
Measured: up to 3 months
Secondary outcomes (2)
Change from Baseline Self-efficacy at 3 months
Measured by Hospice Care Self-efficacy Scale on nurses, a 12 items with a 5-point Likert scale from (1) very diffident to (5) very confident. Higher scores mean a better outcome.
Measured: up to 3 months
Change from Baseline Outcome expectancy beliefs 3 months
Measured by The Communication Outcomes Questionnaire, a 23-item self-report questionnaire with a 9-point Likert scale from 1 = very likely and 9 = very unlikely. Higher scores mean a worse outcome.
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Sep 2023
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Of-LifeStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe 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
- Randomised
- Intervention model
- Sequential
- Model description
- The IG will receive the end-of-life CST between the two measurement points, and the CG will be a waitlist group and receive the training after the end of data collection.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Joyce Chung, The Hong Kong Polytechnic University
- Investigators
- Joyce Chung, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888480
- Sponsor's protocol ID
- HSEARS20230525002
- Status last verified
- Feb 2024
- First submitted
- 9 Feb 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Culturally Specific End-of-life Communication Skills Training for Chinese Oncology Nurses
- ClinicalTrials.gov ID
- NCT05888480
- Acronym / sponsor ID
- HSEARS20230525002
- Conditions
- End-Of-Life
- Keywords
- Communication, Nurse, Terminally ill
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 5 Jun 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.
The goal of this clinical trial is to evaluate the effectiveness of culturally specific end-of-life communication skills training (CST) among Chinese oncology nurses.
The main question it aims to answer is: What is the effectiveness of culturally specific end-of-life CST among Chinese oncology nurses? Participants will receive an 8-week communication skills training. Researchers will compare the intervention group and the wait-list group to see if skills, self-efficacy, and outcome expectancy beliefs will be improved.
Detailed description
Objectives: The study aims to evaluate the effectiveness of culturally specific end-of-life CST among Chinese oncology nurses.
Design and participants: It is designed as a single-blind, pre-post randomized controlled trial (RCT). Registered nurses who work with advanced cancer patients in hospital settings will be recruited. The participants will be randomly assigned to either the intervention group (IG) or the control group (CG). The IG will receive the end-of-life CST between the two measurement points, and the CG will be a waitlist group and receive the training after the end of data collection.
Data analysis: Demographic information about the participants will be summarised in descriptive statistics. Independent t-tests and chi-square tests are used to investigate the comparability of groups in terms of the demographics generated by randomization. The primary and secondary outcome variables will be examined using covariate-adjusted linear mixed models. This approach enables the consideration of missing data. For non-repeated continuous measurements, ordinary linear regression and logistic models will be adopted. The intention-to-treat (ITT) analysis and post hoc analyses of contaminated data will be performed.
Expected results: Nurses' skills, self-efficacy, and outcome expectancy beliefs will improve after the CST.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The IG will receive the end-of-life CST between the two measurement points, and the CG will be a waitlist group and receive the training after the end of data collection.
| Arm | Type | Receives |
|---|---|---|
| Intervention group (IG) | Experimental | Other: The end-of-life communication skills trainingThe IG will receive the end-of-life CST between the two measurement points |
| Control group (CG) | Other | Other: Routine training activityThe CG will be a waitlist group and receive the training after the end of data collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Registered nurses who work with advanced cancer patients in hospital settings
- Consent to participate in the study
Key exclusion criteria (2 listed)
- Nurses working temporarily in the two hospitals as scholars or trainees from other hospitals
- Specialized nurses in palliative care
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 |
|---|---|---|
| The end-of-life communication skills trainingTraining methods include lectures, video demonstrations, and simulation in small groups (4-5 trainees per group with multidisciplinary roles). Written and audiovisual learning materials will be offered. Each session will be 150 minutes, including lectures and video demonstration (90 min/session) and simulation and feedback (60 min/session). One session will be conducted in two weeks. Totally there will be four sessions completed in 8 weeks. | Other | Intervention group (IG) |
| Routine training activityRoutine training activities arranged by relevant departments in hospitals | Other | Control group (CG) |
Primary outcome
Change from Baseline Skills at 3 months
Time frame: up to 3 months
Measured by Nurses' Clinic Communication Competency Scale, a 58-item self-reported scale which measures six dimensions. A 5-point Likert scale from (1) very poor to (5) very good is used. Higher scores mean a better outcome.
2 secondary outcomes
Change from Baseline Self-efficacy at 3 months
Time frame: up to 3 months
Change from Baseline Outcome expectancy beliefs 3 months
Time frame: up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Joyce Chung, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The end-of-life communication skills training and Routine training activity in people with End-Of-Life, run by The Hong Kong Polytechnic University at 1 site in China.
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 2 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 28 Feb 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 China. 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 Joyce Chung, PhD (852-2766-6322, okjoyce.chung@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Skills at 3 months (time frame: up to 3 months). 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 28 Feb 2024.