Clinical trial NCT04659005: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis B
Hepatocellular Carcinoma
Keywords: Hepatocellular carcinoma
Hepatitis B
Screening
Early detection
Nurse-led intervention
Decision counseling
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Henan Provincial People's Hospital
First posted: 2020-12-09
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: HCC screening uptake rates
timeFrame: Immediately after intervention and three months after intervention
Secondary outcomes:
measure: HCC screening knowledge questionnaire
timeFrame: Baseline, immediately after intervention and three months after intervention
measure: Preventive health model construct instrument.
timeFrame: Baseline, immediately after intervention and three months after intervention
measure: Decisional conflict scale
timeFrame: Baseline, immediately after intervention and three months after intervention
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Hong Kong
country: China
facility: The Nethersole School of Nursing, The Chinese University of Hong Kong
state: Hong Kong
Study officials:
affiliation: The Nethersole School of Nursing, The Chinese University of Hong Kong
name: Caixia Li
role: PRINCIPAL_INVESTIGATOR
References: