Nurse-led Decision Counseling on Hepatocellular Carcinoma Screening
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
1 other identifier
interventional
178
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2021
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 31, 2020
CompletedFirst Posted
Study publicly available on registry
December 9, 2020
CompletedStudy Start
First participant enrolled
February 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedApril 6, 2022
March 1, 2022
12 months
October 31, 2020
March 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Immediately after intervention and three months after intervention
Secondary Outcomes (3)
HCC screening knowledge questionnaire
Baseline, immediately after intervention and three months after intervention
Preventive health model construct instrument.
Baseline, immediately after intervention and three months after intervention
Decisional conflict scale
Baseline, immediately after intervention and three months after intervention
Study Arms (2)
Nurse-led decision counseling group
EXPERIMENTALProvide education, tailored information, decision support, and psychosocial support regarding hepatocellular carcinoma screening
Control group
OTHERUsual care provided by the hospital, including one-page written education information about diet, medications, and daily exercises.
Interventions
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The Nethersole School of Nursing, The Chinese University of Hong Kong
Hong Kong, Hong Kong, China
Related Publications (2)
Li C, Lu X, Xu J, Gao F, Lee E, Chan CWH. Effectiveness of a nurse-led decision counselling programme on hepatocellular carcinoma screening uptake among patients with hepatitis B: A randomised controlled trial. Int J Nurs Stud. 2023 Dec;148:104610. doi: 10.1016/j.ijnurstu.2023.104610. Epub 2023 Sep 21.
PMID: 37801936DERIVEDLi C, Lu X, Gao F, Lee E, Chan CWH. Development of a nurse-led decision counseling program for improving hepatocellular carcinoma screening: A typology-guided feasibility study. Asia Pac J Oncol Nurs. 2023 Mar 9;10(6):100215. doi: 10.1016/j.apjon.2023.100215. eCollection 2023 Jun.
PMID: 37305610DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caixia Li
The Nethersole School of Nursing, The Chinese University of Hong Kong
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Ms.
Study Record Dates
First Submitted
October 31, 2020
First Posted
December 9, 2020
Study Start
February 1, 2021
Primary Completion
January 20, 2022
Study Completion
February 28, 2022
Last Updated
April 6, 2022
Record last verified: 2022-03