Nurse-led Decision Counseling on Hepatocellular Carcinoma Screening
Primary Purpose
Hepatitis B, Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Nurse-led decision counseling
Usual care
Sponsored by
About this trial
This is an interventional screening trial for Hepatitis B focused on measuring Hepatocellular carcinoma, Hepatitis B, Screening, Early detection, Nurse-led intervention, Decision counseling
Eligibility Criteria
Inclusion Criteria:
- patients with HBV infection (HBsAg positive), aged 18-65 years old
- have been recommended to have HCC screening, including liver cirrhosis, males over age 40, women over age 50, and family history of HCC
- can understand Chinese
- without an liver ultrasound or serum alpha-fetoprotein test in the previous six months at the time of inclusion
Exclusion Criteria:
- have comorbid condition, including co-infection with hepatitis C, human immunodeficiency virus, and alcoholic liver disease
- have hepatocellular carcinoma diagnosis
- have undergone liver transplantation
- have encephalopathy
- not willing to participate
Sites / Locations
- Henan Provincial People's Hospital
- The Nethersole School of Nursing, The Chinese University of Hong Kong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Nurse-led decision counseling group
Control group
Arm Description
Provide education, tailored information, decision support, and psychosocial support regarding hepatocellular carcinoma screening
Usual care provided by the hospital, including one-page written education information about diet, medications, and daily exercises.
Outcomes
Primary Outcome Measures
HCC screening uptake rates
The liver ultrasound, serum alpha-fetoprotein, dynamic computed tomography, and magnetic resonance are all considered as screening tests in the current study.
Secondary Outcome Measures
HCC screening knowledge questionnaire
It will be developed to measure knowledge regarding HCC and HCC screening recommendations. The yes or no questions and multiple-choice questions will be used to rate participants' responses by giving one point for a correct answer and zero point for an incorrect answer.
Preventive health model construct instrument.
It has five domains with 16 items measuring salience and coherence (four items), cancer worriers (two items), perceived susceptibility (four items), response efficacy (two items), and social influence (four items).
Decisional conflict scale
It consists of five subscales, including uncertainty, feeling informed, clarify related to personal values, feeling supported, and effective decision-making.
Full Information
NCT ID
NCT04659005
First Posted
October 31, 2020
Last Updated
March 27, 2022
Sponsor
Chinese University of Hong Kong
Collaborators
Henan Provincial People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04659005
Brief Title
Nurse-led Decision Counseling on Hepatocellular Carcinoma Screening
Official Title
Pilot Testing and Evaluation of a Nurse-led Decision Counseling Program to Improve Decision-making and Uptake of Hepatocellular Carcinoma Screening Among Patients With Hepatitis B Virus Infection: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
January 20, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
Collaborators
Henan Provincial People's Hospital
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
Hepatocellular carcinoma (HCC) is a common malignancy with poor prognosis worldwide. The asymptomatic of early-stage HCC may lead most patients diagnosed at advanced stages. This highlights the importance of HCC screening among high-risk populations to detect HCC at early stages and achieve better survival. Hepatitis B virus (HBV) infection is a major cause of HCC in China, but the utilization of HCC screening is suboptimal among patients with HBV infection.
Currently, there are no-theory based intervention, to our knowledge, has been reported to improve HCC screening decision-making and uptake among patients with HBV infection . Therefore, based on our previous systematic review, the current study has proposed a nurse-led decision counseling program to improve decision-making and uptake of HCC screening among patients with HBV infection in mainland China.
Participants in intervention group will receive nurse-led decision counseling. The intervention components include 40-minute education and tailored information regarding HCC screening. At the second week, decision support will be provided through 30-minute telephone call. At the third week, another telephone call (20 minutes) will be provided to help participants identify and address barriers to HCC screening.
Participants in control group will receive usual care. After the intervention and at 3-month follow-up, the study will collect data related to HCC screening uptake rates. Findings are paramount to promote informed choice in HCC screening and early HCC detection to improve survival outcomes among patients with HBV infection.
Detailed Description
Participants in the intervention group will receive the following three-week, three-session intervention. The details are as follows.
Education (20 min). At first week, education will be delivered through face-to-face for the following information: (1) HBV infection and increased HCC risk; (2) HCC screening recommendations regarding eligibility, available screening tests and recommended screening intervals; (3) pros/advantages of undergoing HCC screening; (4) cons/disadvantages or uncertainties of undergoing HCC screening; (5) implications of positive screening results; and (6) health costs. The education material will be present in a self-made manual, which will be explained and distributed to each participant.
Tailored psychosocial information (20 min). It will be conducted after education. The tailored messages will be developed to form a message library for each sub-scale of the preventive health model instrument with scoring ≤ 3 and > 3. The contents will be based on HCC screening guidelines and recommendations. The nurse counsellor will select and explain tailored information based on individual's responses to the preventive health model instrument.
Values clarification exercises (30 min). At the second week, the decision counselor will work with participants through telephone-based way to go through values clarification exercises, in which participants will: (1) review the listed pros and cons decision factors of undergoing HCC screening one by one; (2) indicate the extent to which each pros and cons matters to them by giving stars; (3) add any other reasons for choosing or not choosing HCC screening and indicate their importance; and (4) indicate their decision preferences toward undergoing HCC screening, unsure, or not undergoing HCC screening.
Exploring and addressing implementation barriers (20 min). At the third week, the decision counselor will work with participants, through telephone-based ways, to explore possible barriers to undertake HCC screening; identify possible solutions or available resources to the identified barriers via brainstorming; and encourage implementation of the chosen solution to overcome the barriers and schedule for HCC screening.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B, Hepatocellular Carcinoma
Keywords
Hepatocellular carcinoma, Hepatitis B, Screening, Early detection, Nurse-led intervention, Decision counseling
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
178 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nurse-led decision counseling group
Arm Type
Experimental
Arm Description
Provide education, tailored information, decision support, and psychosocial support regarding hepatocellular carcinoma screening
Arm Title
Control group
Arm Type
Other
Arm Description
Usual care provided by the hospital, including one-page written education information about diet, medications, and daily exercises.
Intervention Type
Other
Intervention Name(s)
Nurse-led decision counseling
Intervention Description
Provide education, tailored information, decision support, and psychosocial support regarding hepatocellular carcinoma screening
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
Usual care provided by the hospital, including one-page written education information about diet, medications, and daily exercises
Primary Outcome Measure Information:
Title
HCC screening uptake rates
Description
The liver ultrasound, serum alpha-fetoprotein, dynamic computed tomography, and magnetic resonance are all considered as screening tests in the current study.
Time Frame
Immediately after intervention and three months after intervention
Secondary Outcome Measure Information:
Title
HCC screening knowledge questionnaire
Description
It will be developed to measure knowledge regarding HCC and HCC screening recommendations. The yes or no questions and multiple-choice questions will be used to rate participants' responses by giving one point for a correct answer and zero point for an incorrect answer.
Time Frame
Baseline, immediately after intervention and three months after intervention
Title
Preventive health model construct instrument.
Description
It has five domains with 16 items measuring salience and coherence (four items), cancer worriers (two items), perceived susceptibility (four items), response efficacy (two items), and social influence (four items).
Time Frame
Baseline, immediately after intervention and three months after intervention
Title
Decisional conflict scale
Description
It consists of five subscales, including uncertainty, feeling informed, clarify related to personal values, feeling supported, and effective decision-making.
Time Frame
Baseline, immediately after intervention and three months after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with HBV infection (HBsAg positive), aged 18-65 years old
have been recommended to have HCC screening, including liver cirrhosis, males over age 40, women over age 50, and family history of HCC
can understand Chinese
without an liver ultrasound or serum alpha-fetoprotein test in the previous six months at the time of inclusion
Exclusion Criteria:
have comorbid condition, including co-infection with hepatitis C, human immunodeficiency virus, and alcoholic liver disease
have hepatocellular carcinoma diagnosis
have undergone liver transplantation
have encephalopathy
not willing to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caixia Li
Organizational Affiliation
The Nethersole School of Nursing, The Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The Nethersole School of Nursing, The Chinese University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://doi.org/https://doi.org/10.1016/j.ijnurstu.2020.103684
Description
Our published review used to develop the current intervention and titled: Effects of nurse-led interventions on early detection of cancer: A systematic review and meta-analysis
Learn more about this trial
Nurse-led Decision Counseling on Hepatocellular Carcinoma Screening
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