Nurse-led Decision Counseling on Hepatocellular Carcinoma Screening
Condition: Hepatitis B; Hepatocellular Carcinoma
MeSH terms: Hepatitis A; Hepatitis B; Carcinoma; Carcinoma, Hepatocellular; Hepatitis
Study type: Interventional

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.
    

Intervention name(s): Nurse-led decision counseling; Usual care
Intervention type(s): Other; Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Screening
Keywords: Hepatocellular carcinoma; Hepatitis B; Screening; Early detection; Nurse-led intervention; Decision counseling