Hepatocellular CancerNCT03926039
Sharing Decision-making Program for HCC Patients Treatment Decisions
A study testing sharing decision-making program in people with Hepatocellular Cancer, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
Trial summary
Aim: Explore the effectiveness of sharing decision-making program interventions in the early stage of HCC to reduce treatment decisions conflicts and improving decision-making satisfaction. Design: An experimental design will be used in the study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Cancer
- What is being tested?
- sharing decision-making program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2019to 6 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary liver cancer patients (ICD 10 is C22.0) and Barcelona stage (BCLC stage) 0-A.
- At least 20 years of age.
- No mental illness.
- Patients who can communicate in Mandarin or Taiwanese.
Who cannot join
- Don't know himself condition.
- Unconscious patients.
- Patients with liver cancer resection or partial liver resection were performed within 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Sharing Decision-making Program Interventions in the Early Stage of HCC to Reduce Treatment Decisions Conflicts and Improving Decision-making Satisfaction
Aim: Explore the effectiveness of sharing decision-making program interventions in the early stage of HCC to reduce treatment decisions conflicts and improving decision-making satisfaction.
Design: An experimental design will be used in the study. The 102 primary liver cancer patients, who were diagnosed with Barcelona stage(BCLC stage) 0-A, will be recruited and randomized to the control or intervention group. The intervention measures in this study "sharing decision-making plan" mainly includes sharing the decision-making talks and the decision-making assistance tools used in the process.
Read the detailed description
The effectiveness of sharing decision-making program interventions in the early stage of HCC to reduce treatment decisions conflicts and improving decision-making satisfactionHepatocarcinoma (HCC) is a high incidence and high mortality disease. Hepatocarcinoma is also a very common disease in Taiwan. Treatment options are limited to those patients with advanced Hepatocarcinoma. However, there are many options for patients with compensated cirrhosis, and small liver tumors are potentially resectable. When patients understood the detailed assessment of the disease both doctors and patients can set the best treatment goals. Sharing decision-making is a patient-centered collaborative processes that enable individuals and their healthcare providers to make decisions together, but patient engagement appears to be less optimistic and there is a lack of evidence that the link between sharing decision-making measures and patient behavior and health outcomes. When decisions are made under social stress or time constraints, people may make less than optimal decisions when they lack sufficient information or skills. Since then the treatment does not match the expected results, often result in decision regrets or arguments with the medical team, and even evolved into medical lawsuits. Therefore, the purpose of this study is to explore the effectiveness of sharing decision-making program interventions in the early stage of HCC to reduce treatment decisions conflicts and improving decision-making satisfaction. In this study, investigators took the experimental design to assess the cases of early hepatocellular carcinoma in hepato- gastroenterology, surgery and oncology clinical in a teaching hospital in the eastern part of Taiwan.
The intervention measures in this study "sharing decision-making plan" mainly includes sharing the decision-making talks and the decision-making assistance tools used in the process. According to Elwyn et.al. (2012), the decision-sharing model was proposed to intervene in the treatment decision-making of early liver cancer patients, including Choice talk, Option talk, Decision talk, and decision-making. Decision support for the process, where the investigator meets with the patient and its important others in the interdisciplinary discussion room or ward meeting room.
Second, decision assistance tools. Decision assistance tools provide information about options and outcomes, and clarify personal values to help people participate in decision making. The aim is to supplement, rather than replace, medical staff counseling (Collins et al., 2009), and the quality of decision aids is very important. Satisfaction with the use of tools is associated with increased patient satisfaction and reduced decision-making. Patients can benefit from computerized decision-making tools without the need to increase physician involvement.
The research tools include basic population data, clinical stage of disease, self-efficacy scale of hepatocellular carcinoma, Decision Decision Confidence Scale (DCS), decision self-efficacy scale , Decision Satisfaction Scale and Chinese Simplified-form Mandarin Health Literacy Scale.
The obtained data were collected and analyzed by SPSS20.0 for Window software. The main statistical methods include descriptive statistics, T-test, analysis of variance, Pearson Product Moment correlation coefficient and Generalized Estimating Equations (GEEs) ).
- Conditions
- Hepatocellular Cancer
- Being tested
- sharing decision-making program
- Keywords
- Hepatocarcinoma, sharing decision-making, Health Literacy, decisional conflicts
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sharing decision-making programBehavioural
Sharing decision-making talks and decision-making assistance tools used in the process
| Study group | Role | What they receive |
|---|---|---|
| sharing decision-making program interventions | Experimental | Description of conventional traditional treatment options and add sharing decision-making program The intervention measures in this study "sharing decision-making plan" mainly includes sharing the decision-making talks and the decision-making assistance tools used in the process. Receives: Behavioral: sharing decision-making program |
| Description of traditional treatment options | No intervention | Description of conventional traditional treatment options |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional Conflict Scale
5 questions for a total of 16 questions, respectively, to assess the uncertainty of the subscale (10-12 questions) the subscale total score range 0-300 points , informed subscales (1-3 questions) the subscale total score range 0-300 points, values subscales (4-6 questions) the subscale total score range 0-300 points, support subscales ( 7-9 questions) the subscale total score range 0-300 points, effective decision-making scale (13-16 questions) the subscale total score range 0-300 points, Each question is scored on a Likert scale of 0-4 points (very strongly agreed to very disagree), then multiplied by 25 so that each question may score 0-100 points. A score of 0 is a good decision, and a score of 100 is the worst decision. the total score was 0 to 1600 points.
Measured: 1 week
Secondary outcomes (3)
Satisfaction With Decision Instrument
The content consists of 6 items, with a score of 1-5 points (very strongly disagreed and very agreeable) for each question. The score may be 6-30 points. The higher the score, the higher the satisfaction with the decision. A score of 6 indicates that the extreme dissatisfaction of 30 points indicates extreme satisfaction.
Measured: 1 week
Decision Self-efficacy Scale
The scale included 11 questions, and participants were asked to think about how confident they were in making informed choices in 11 situations. The scoring for each situation is scored on a Likert scale with 0-4 points (very agrees to very disagree) for each question, then multiplied by 25 so that each question may score 0-100 points. The higher the score, the more confident participant are. Each question 0 points is not confident, 100 points is very confident. total score range is 0- 1100 points
Measured: 1 week
Liver Cancer Treatment Options Related Knowledge Scale
A total of 20 questions total score of 100 points, the higher the knowledge, the better.Total scale range was 5-100 points.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start1 May 2019
- Primary completion6 Mar 2020
- Study completion6 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CancerStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Blocked Randomization is a common disease in patients with liver cancer. In order to avoid excessive concentration of the patient control group and the experimental group, the mining blocks are randomly assigned.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Lotung Poh-Ai Hospital
- Responsible party
- Principal investigator, Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences
- Investigators
- Tsae Jyy Wang, PhD, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926039
- Sponsor's protocol ID
- CMUH108-REC3-002
- Status last verified
- Oct 2021
- First submitted
- 16 Apr 2019
- Last updated
- 29 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Degner LF, Kristjanson LJ, Bowman D, Sloan JA, Carriere KC, O'Neil J, Bilodeau B, Watson P, Mueller B. Information needs and decisional preferences in women with breast cancer. JAMA. 1997 May 14;277(18):1485-92.
PubMed 9145723Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
PubMed 9505581Bruix J, Reig M, Sherman M. Evidence-Based Diagnosis, Staging, and Treatment of Patients With Hepatocellular Carcinoma. Gastroenterology. 2016 Apr;150(4):835-53. doi: 10.1053/j.gastro.2015.12.041. Epub 2016 Jan 12.
PubMed 26795574Katie Lee SY, Knobf MT. Primary Breast Cancer Decision-making Among Chinese American Women: Satisfaction, Regret. Nurs Res. 2015 Sep-Oct;64(5):391-401. doi: 10.1097/NNR.0000000000000116.
PubMed 26325281Liao YL, Wang TJ, Su CW, Liang SY, Liu CY, Fan JY. Efficacy of a Decision Support Intervention on Decisional Conflict Related to Hepatocellular Cancer Treatment: A Randomized Controlled Trial. Clin Nurs Res. 2023 Jan;32(1):233-243. doi: 10.1177/10547738221121447. Epub 2022 Sep 8.
PubMed 36082423
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Sharing Decision-making Program Interventions in the Early Stage of HCC to Reduce Treatment Decisions Conflicts and Improving Decision-making Satisfaction
- ClinicalTrials.gov ID
- NCT03926039
- Acronym / sponsor ID
- CMUH108-REC3-002
- Conditions
- Hepatocellular Cancer
- Keywords
- Hepatocarcinoma, sharing decision-making, Health Literacy, decisional conflicts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Collaborators
- Lotung Poh-Ai Hospital
- Study start
- 1 May 2019 (actual)
- Primary completion
- 6 Mar 2020 (actual)
- Study completion
- 6 Mar 2020 (actual)
- First posted
- 24 Apr 2019 (actual)
- Results
- Posted 15 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim: Explore the effectiveness of sharing decision-making program interventions in the early stage of HCC to reduce treatment decisions conflicts and improving decision-making satisfaction.
Design: An experimental design will be used in the study. The 102 primary liver cancer patients, who were diagnosed with Barcelona stage(BCLC stage) 0-A, will be recruited and randomized to the control or intervention group. The intervention measures in this study "sharing decision-making plan" mainly includes sharing the decision-making talks and the decision-making assistance tools used in the process.
Detailed description
The effectiveness of sharing decision-making program interventions in the early stage of HCC to reduce treatment decisions conflicts and improving decision-making satisfactionHepatocarcinoma (HCC) is a high incidence and high mortality disease. Hepatocarcinoma is also a very common disease in Taiwan. Treatment options are limited to those patients with advanced Hepatocarcinoma. However, there are many options for patients with compensated cirrhosis, and small liver tumors are potentially resectable. When patients understood the detailed assessment of the disease both doctors and patients can set the best treatment goals. Sharing decision-making is a patient-centered collaborative processes that enable individuals and their healthcare providers to make decisions together, but patient engagement appears to be less optimistic and there is a lack of evidence that the link between sharing decision-making measures and patient behavior and health outcomes. When decisions are made under social stress or time constraints, people may make less than optimal decisions when they lack sufficient information or skills. Since then the treatment does not match the expected results, often result in decision regrets or arguments with the medical team, and even evolved into medical lawsuits. Therefore, the purpose of this study is to explore the effectiveness of sharing decision-making program interventions in the early stage of HCC to reduce treatment decisions conflicts and improving decision-making satisfaction. In this study, investigators took the experimental design to assess the cases of early hepatocellular carcinoma in hepato- gastroenterology, surgery and oncology clinical in a teaching hospital in the eastern part of Taiwan.
The intervention measures in this study "sharing decision-making plan" mainly includes sharing the decision-making talks and the decision-making assistance tools used in the process. According to Elwyn et.al. (2012), the decision-sharing model was proposed to intervene in the treatment decision-making of early liver cancer patients, including Choice talk, Option talk, Decision talk, and decision-making. Decision support for the process, where the investigator meets with the patient and its important others in the interdisciplinary discussion room or ward meeting room.
Second, decision assistance tools. Decision assistance tools provide information about options and outcomes, and clarify personal values to help people participate in decision making. The aim is to supplement, rather than replace, medical staff counseling (Collins et al., 2009), and the quality of decision aids is very important. Satisfaction with the use of tools is associated with increased patient satisfaction and reduced decision-making. Patients can benefit from computerized decision-making tools without the need to increase physician involvement.
The research tools include basic population data, clinical stage of disease, self-efficacy scale of hepatocellular carcinoma, Decision Decision Confidence Scale (DCS), decision self-efficacy scale , Decision Satisfaction Scale and Chinese Simplified-form Mandarin Health Literacy Scale.
The obtained data were collected and analyzed by SPSS20.0 for Window software. The main statistical methods include descriptive statistics, T-test, analysis of variance, Pearson Product Moment correlation coefficient and Generalized Estimating Equations (GEEs) ).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Blocked Randomization is a common disease in patients with liver cancer. In order to avoid excessive concentration of the patient control group and the experimental group, the mining blocks are randomly assigned.
| Arm | Type | Receives |
|---|---|---|
| sharing decision-making program interventions | Experimental | Behavioral: sharing decision-making programDescription of conventional traditional treatment options and add sharing decision-making program The intervention measures in this study "sharing decision-making plan" mainly includes sharing the decision-making talks and the decision-making assistance tools used in the process. |
| Description of traditional treatment options | No intervention | –Description of conventional traditional treatment options |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Primary liver cancer patients (ICD 10 is C22.0) and Barcelona stage (BCLC stage) 0-A.
- At least 20 years of age.
- No mental illness.
- Patients who can communicate in Mandarin or Taiwanese.
Key exclusion criteria (3 listed)
- Don't know himself condition.
- Unconscious patients.
- Patients with liver cancer resection or partial liver resection were performed within 3 months.
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 |
|---|---|---|
| sharing decision-making programSharing decision-making talks and decision-making assistance tools used in the process | Behavioural | sharing decision-making program interventions |
Primary outcome
Decisional Conflict Scale
Time frame: 1 week
5 questions for a total of 16 questions, respectively, to assess the uncertainty of the subscale (10-12 questions) the subscale total score range 0-300 points , informed subscales (1-3 questions) the subscale total score range 0-300 points, values subscales (4-6 questions) the subscale total score range 0-300 points, support subscales ( 7-9 questions) the subscale total score range 0-300 points, effective decision-making scale (13-16 questions) the subscale total score range 0-300 points, Each question is scored on a Likert scale of 0-4 points (very strongly agreed to very disagree), then multiplied by 25 so that each question may score 0-100 points. A score of 0 is a good decision, and a score of 100 is the worst decision. the total score was 0 to 1600 points.
3 secondary outcomes
Satisfaction With Decision Instrument
Time frame: 1 week
Decision Self-efficacy Scale
Time frame: 1 week
Liver Cancer Treatment Options Related Knowledge Scale
Time frame: 1 week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9145723Degner LF, Kristjanson LJ, Bowman D, Sloan JA, Carriere KC, O'Neil J, Bilodeau B, Watson P, Mueller B. Information needs and decisional preferences in women with breast cancer. JAMA. 1997 May 14;277(18):1485-92.
- Background: PubMed 9505581Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
- Background: PubMed 26795574Bruix J, Reig M, Sherman M. Evidence-Based Diagnosis, Staging, and Treatment of Patients With Hepatocellular Carcinoma. Gastroenterology. 2016 Apr;150(4):835-53. doi: 10.1053/j.gastro.2015.12.041. Epub 2016 Jan 12.
- Background: PubMed 26325281Katie Lee SY, Knobf MT. Primary Breast Cancer Decision-making Among Chinese American Women: Satisfaction, Regret. Nurs Res. 2015 Sep-Oct;64(5):391-401. doi: 10.1097/NNR.0000000000000116.
- Derived from this study: PubMed 36082423Liao YL, Wang TJ, Su CW, Liang SY, Liu CY, Fan JY. Efficacy of a Decision Support Intervention on Decisional Conflict Related to Hepatocellular Cancer Treatment: A Randomized Controlled Trial. Clin Nurs Res. 2023 Jan;32(1):233-243. doi: 10.1177/10547738221121447. Epub 2022 Sep 8.
- Individual participant dataSharing planned: No
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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.
Tsae Jyy Wang, PhD principal investigator
National Taipei University of Nursing and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sharing decision-making program in people with Hepatocellular Cancer, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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 3 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 29 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Yes. Results are posted in the registry (first posted 15 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Decisional Conflict Scale (time frame: 1 week). 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 NCT03926039, which also lists 5 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 29 Oct 2021.