- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05888480
A Culturally Specific End-of-life Communication Skills Training
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Joyce Chung, PhD
- Phone Number: 852-2766-6322
- Email: okjoyce.chung@polyu.edu.hk
Study Locations
-
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Zhejiang
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Hangzhou, Zhejiang, China, 310000
- Recruiting
- Zhejiang Cancer Hospital
-
Contact:
- Weilin Chen, Master
- Phone Number: 86-15715792337
- Email: wei-lin.chen@connect.polyu.hk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Registered nurses who work with advanced cancer patients in hospital settings
- Consent to participate in the study
Exclusion Criteria:
- Nurses working temporarily in the two hospitals as scholars or trainees from other hospitals
- Specialized nurses in palliative care
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group (IG)
The IG will receive the end-of-life CST between the two measurement points
|
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.
|
Other: Control group (CG)
The CG will be a waitlist group and receive the training after the end of data collection.
|
Routine training activities arranged by relevant departments in hospitals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline Self-efficacy at 3 months
Time Frame: up to 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.
|
up to 3 months
|
Change from Baseline Outcome expectancy beliefs 3 months
Time Frame: up to 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.
|
up to 3 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acceptance and satisfaction
Time Frame: up to 3 months
|
Self-developed items and open questions anout the training experience
|
up to 3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Joyce Chung, PhD, The Hong Kong Polytechnic University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSEARS20230525002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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