Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatitis B | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nurse-led decision counseling | Other | — | UNRESOLVED |
| Usual care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Nurse-led decision counseling group
- description
- Provide education, tailored information, decision support, and psychosocial support regarding hepatocellular carcinoma screening
- interventionNames
- Other: Nurse-led decision counseling
- type
- OTHER
- label
- Control group
- description
- Usual care provided by the hospital, including one-page written education information about diet, medications, and daily exercises.
- interventionNames
- Other: Usual care
Primary outcomes (1)
- measure
- HCC screening uptake rates
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDLi 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 37801936
- DERIVEDLi 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 37305610