A Culturally Specific End-of-life Communication Skills Training
Primary Purpose
End-Of-Life
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The end-of-life communication skills training
Routine training activity
Sponsored by
About this trial
This is an interventional other trial for End-Of-Life focused on measuring Communication, Nurse, Terminally ill
Eligibility Criteria
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
Sites / Locations
- Zhejiang Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Intervention group (IG)
Control group (CG)
Arm Description
The IG will receive the end-of-life CST between the two measurement points
The CG will be a waitlist group and receive the training after the end of data collection.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05888480
First Posted
February 9, 2023
Last Updated
September 24, 2023
Sponsor
The Hong Kong Polytechnic University
1. Study Identification
Unique Protocol Identification Number
NCT05888480
Brief Title
A Culturally Specific End-of-life Communication Skills Training
Official Title
Effects of a Culturally Specific End-of-life Communication Skills Training for Chinese Oncology Nurses
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hong Kong Polytechnic University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Of-Life
Keywords
Communication, Nurse, Terminally ill
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
148 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention group (IG)
Arm Type
Experimental
Arm Description
The IG will receive the end-of-life CST between the two measurement points
Arm Title
Control group (CG)
Arm Type
Other
Arm Description
The CG will be a waitlist group and receive the training after the end of data collection.
Intervention Type
Other
Intervention Name(s)
The end-of-life communication skills training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Routine training activity
Intervention Description
Routine training activities arranged by relevant departments in hospitals
Primary Outcome Measure Information:
Title
Change from Baseline Skills at 3 months
Description
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.
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Change from Baseline Self-efficacy at 3 months
Description
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.
Time Frame
up to 3 months
Title
Change from Baseline Outcome expectancy beliefs 3 months
Description
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.
Time Frame
up to 3 months
Other Pre-specified Outcome Measures:
Title
Acceptance and satisfaction
Description
Self-developed items and open questions anout the training experience
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joyce Chung, PhD
Phone
852-2766-6322
Email
okjoyce.chung@polyu.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joyce Chung, PhD
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weilin Chen, Master
Phone
86-15715792337
Email
wei-lin.chen@connect.polyu.hk
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Culturally Specific End-of-life Communication Skills Training
We'll reach out to this number within 24 hrs