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Nurse-led Decision Counseling on Hepatocellular Carcinoma Screening

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ClinicalTrials.gov Identifier: NCT04659005
Recruitment Status : Not yet recruiting
First Posted : December 9, 2020
Last Update Posted : December 9, 2020
Sponsor:
Collaborator:
Henan Provincial People's Hospital
Information provided by (Responsible Party):
LI Caixia, Chinese University of Hong Kong

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hepatitis B Hepatocellular Carcinoma Other: Nurse-led decision counseling Other: Usual care Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: 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
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04659005


Contacts
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Contact: Caixia LI (852) 52610019 caixiali@link.cuhk.edu.hk
Contact: Carmen Chan whchan@cuhk.edu.hk

Locations
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China, Hong Kong
The Nethersole School of Nursing, The Chinese University of Hong Kong
Hong Kong, Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Henan Provincial People's Hospital
Investigators
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Principal Investigator: Caixia Li The Nethersole School of Nursing, The Chinese University of Hong Kong
More Information
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Additional Information:

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Responsible Party: LI Caixia, Ms., Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT04659005    
Other Study ID Numbers: cuhknurs01
First Posted: December 9, 2020    Key Record Dates
Last Update Posted: December 9, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LI Caixia, Chinese University of Hong Kong:
Hepatocellular carcinoma
Hepatitis B
Screening
 Early detection
Nurse-led intervention
Decision counseling
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Carcinoma
Carcinoma, Hepatocellular
Hepatitis
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Blood-Borne Infections
Communicable Diseases
Hepadnaviridae Infections
DNA Virus Infections