Hepatitis BNCT04659005
Nurse-led Decision Counseling on Hepatocellular Carcinoma Screening
A study testing Nurse-led decision counseling in people with Hepatitis B and Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis B, Hepatocellular Carcinoma
- What is being tested?
- Nurse-led decision counseling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
The Nethersole School of Nursing, The Chinese University of Hong Kong
Hong Kong, Hong Kong
Henan Provincial People's Hospital
Zhengzhou, Henan
About this study
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
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.
Read more
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.
Read the 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.
- Conditions
- Hepatitis B, Hepatocellular Carcinoma
- Being tested
- Nurse-led decision counseling, Usual care
- Keywords
- Hepatocellular carcinoma, Hepatitis B, Screening, Early detection, Nurse-led intervention, Decision counseling
- Medical subject headings
- Hepatitis B, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led decision counselingOther
Provide education, tailored information, decision support, and psychosocial support regarding hepatocellular carcinoma screening
Usual careOther
Usual care provided by the hospital, including one-page written education information about diet, medications, and daily exercises
| Study group | Role | What they receive |
|---|---|---|
| Nurse-led decision counseling group | Experimental | Provide education, tailored information, decision support, and psychosocial support regarding hepatocellular carcinoma screening Receives: Other: Nurse-led decision counseling |
| Control group | Other | Usual care provided by the hospital, including one-page written education information about diet, medications, and daily exercises. Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
HCC screening uptake rates
The liver ultrasound, serum alpha-fetoprotein, dynamic computed tomography, and magnetic resonance are all considered as screening tests in the current study.
Measured: Immediately after intervention and three months after intervention
Secondary outcomes (3)
HCC screening knowledge questionnaire
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.
Measured: Baseline, immediately after intervention and three months after intervention
Preventive health model construct instrument.
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).
Measured: Baseline, immediately after intervention and three months after intervention
Decisional conflict scale
It consists of five subscales, including uncertainty, feeling informed, clarify related to personal values, feeling supported, and effective decision-making.
Measured: Baseline, immediately after intervention and three months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start1 Feb 2021
- Primary completion20 Jan 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial People's Hospital
- Responsible party
- Principal investigator, LI Caixia, Chinese University of Hong Kong
- Investigators
- Caixia Li, Principal investigator, The Nethersole School of Nursing, The Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04659005
- Sponsor's protocol ID
- cuhknurs01
- Status last verified
- Mar 2022
- First submitted
- 31 Oct 2020
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Li 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.
PubMed 37801936Li 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.
PubMed 37305610
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04659005
- Acronym / sponsor ID
- cuhknurs01
- Conditions
- Hepatitis B, Hepatocellular Carcinoma
- Keywords
- Hepatocellular carcinoma, Hepatitis B, Screening, Early detection, Nurse-led intervention, Decision counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Collaborators
- Henan Provincial People's Hospital
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 20 Jan 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 9 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse-led decision counseling group | Experimental | Other: Nurse-led decision counselingProvide education, tailored information, decision support, and psychosocial support regarding hepatocellular carcinoma screening |
| Control group | Other | Other: Usual careUsual care provided by the hospital, including one-page written education information about diet, medications, and daily exercises. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led decision counselingProvide education, tailored information, decision support, and psychosocial support regarding hepatocellular carcinoma screening | Other | Nurse-led decision counseling group |
| Usual careUsual care provided by the hospital, including one-page written education information about diet, medications, and daily exercises | Other | Control group |
Primary outcome
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.
3 secondary outcomes
HCC screening knowledge questionnaire
Time frame: 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
Decisional conflict scale
Time frame: Baseline, immediately after intervention and three months after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Derived from this study: PubMed 37801936Li 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.
- Derived from this study: PubMed 37305610Li 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.
- Our published review used to develop the current intervention and titled: Effects of nurse-led interventions on early detection of cancer: A systematic review and meta-analysisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caixia Li principal investigator
The Nethersole School of Nursing, The Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led decision counseling in people with Hepatitis B and Hepatocellular Carcinoma, run by Chinese University of Hong Kong at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HCC screening uptake rates (time frame: Immediately after intervention and three months after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04659005, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.