Nurse-led Decision Counseling on Hepatocellular Carcinoma Screening

March 27, 2022 updated by: LI Caixia, Chinese University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China
        • Henan Provincial People's Hospital
    • Hong Kong
      • Hong Kong, Hong Kong, China
        • The Nethersole School of Nursing, The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nurse-led decision counseling group
Provide education, tailored information, decision support, and psychosocial support regarding hepatocellular carcinoma screening
Other: Nurse-led decision counseling
Provide education, tailored information, decision support, and psychosocial support regarding hepatocellular carcinoma screening
Other: Control group
Usual care provided by the hospital, including one-page written education information about diet, medications, and daily exercises.
Other: Usual care
Usual care provided by the hospital, including one-page written education information about diet, medications, and daily exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCC screening uptake rates
Time Frame: Immediately after intervention and three months after intervention
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCC screening knowledge questionnaire
Time Frame: Baseline, immediately after intervention and three months after intervention
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.
Baseline, immediately after intervention and three months after intervention
Preventive health model construct instrument.
Time Frame: Baseline, immediately after intervention and three months after intervention
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).
Baseline, immediately after intervention and three months after intervention
Decisional conflict scale
Time Frame: Baseline, immediately after intervention and three months after intervention
It consists of five subscales, including uncertainty, feeling informed, clarify related to personal values, feeling supported, and effective decision-making.
Baseline, immediately after intervention and three months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Henan Provincial People's Hospital

Investigators

  • Principal Investigator: Caixia Li, The Nethersole School of Nursing, The Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

January 20, 2022

Study Completion (Actual)

February 28, 2022

Study Registration Dates

First Submitted

October 31, 2020

First Submitted That Met QC Criteria

December 2, 2020

First Posted (Actual)

December 9, 2020

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

March 27, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cuhknurs01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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