Hepatocellular Cancer
Conditions
Keywords
Hepatocarcinoma, sharing decision-making, Health Literacy, decisional conflicts
Brief 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. 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) ).
Interventions
BEHAVIORALsharing decision-making program
Sharing decision-making talks and decision-making assistance tools used in the process
Sponsors
Lotung Poh-Ai Hospital
National Taipei University of Nursing and Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Primary liver cancer patients (ICD 10 is C22.0) and Barcelona stage (BCLC stage) 0-A. 2. At least 20 years of age. 3. No mental illness. 4. Patients who can communicate in Mandarin or Taiwanese.
Exclusion criteria
1. Don't know himself condition. 2. Unconscious patients. 3. Patients with liver cancer resection or partial liver resection were performed within 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Decisional Conflict Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction With Decision Instrument | 1 week | 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. |
| Decision Self-efficacy Scale | 1 week | 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 |
| Liver Cancer Treatment Options Related Knowledge Scale | 1 week | A total of 20 questions total score of 100 points, the higher the knowledge, the better.Total scale range was 5-100 points. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Control Preference Scale | 1 week | The scale is patients make treatment decisions in life-threatening conditions. For the first time, ask patients about their preferred clinical decision-making role. Then, ask a second time for the style they experienced. The instrument doesn't have any score on a scale. Each question was counted independently, the maximum is the number of participants in each group. the minimum is zero. |
| Decision Regret Scale | around 3 month after discharge | The DRS was used to evaluate the feeling of regret after making a decision. There are 5 questions on the scale. The scoring of each situation is based on a Likert scale of 1-5 points (from strongly agree to strongly disagree) for each question. The score is subtracted by 1 and then multiplied by 25, so that each question may be scored 0-100 Minute. The final score is added and averaged. The score range is 0-100 points. The higher the score, the more regretful it is, the 0 point means no regret and 100 points means very regret. |
Countries
Taiwan
Participant flow
Recruitment details
After screening for inclusion and exclusion criteria, cases eligible for admission were recruited, and the researcher explained the research purpose and steps to the research subjects in the clinic room and completed the consent form after the patient agreed to participate in the study. Randomly assigned to control or experimental groups
Participants by arm
| Arm | Count |
|---|---|
| Sharing Decision-making Program Interventions 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.
sharing decision-making program: Sharing decision-making talks and decision-making assistance tools used in the process | 35 |
| Description of Traditional Treatment Options Description of conventional traditional treatment options | 34 |
| Total | 69 |
Baseline characteristics
| Characteristic | Sharing Decision-making Program Interventions | Description of Traditional Treatment Options | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 18 Participants | 18 Participants | 36 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 16 Participants | 33 Participants |
| Age, Continuous | 63.9 years STANDARD_DEVIATION 11.3 | 67.1 years STANDARD_DEVIATION 13.5 | 65.7 years STANDARD_DEVIATION 12.5 |
| BCLC stage BCLC stage 0 (very early stage) | 12 Participants | 14 Participants | 26 Participants |
| BCLC stage BCLC stage A (early stage) | 19 Participants | 14 Participants | 33 Participants |
| BCLC stage BCLC stage B (intermediate stage) | 4 Participants | 6 Participants | 10 Participants |
| Race/Ethnicity, Customized Asian | 35 Participants | 34 Participants | 69 Participants |
| Region of Enrollment Taiwan | 35 Participants | 34 Participants | 69 Participants |
| Sex: Female, Male Female | 11 Participants | 12 Participants | 23 Participants |
| Sex: Female, Male Male | 24 Participants | 22 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 34 |
| other Total, other adverse events | 0 / 35 | 0 / 34 |
| serious Total, serious adverse events | 0 / 35 | 0 / 34 |
Outcome results
Primary
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.
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sharing Decision-making Program Interventions | Decisional Conflict Scale | 6.9 score on a scale | Standard Deviation 9.7 |
| Description of Traditional Treatment Options | Decisional Conflict Scale | 11 score on a scale | Standard Deviation 14.3 |
Comparison: Both group of average difference (95% CI) in intervention group and control groupp-value: 0.05ANOVA
Secondary
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
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sharing Decision-making Program Interventions | Decision Self-efficacy Scale | 73.3 score on a scale | Standard Deviation 11.4 |
| Description of Traditional Treatment Options | Decision Self-efficacy Scale | 72.1 score on a scale | Standard Deviation 15.6 |
Secondary
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.
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sharing Decision-making Program Interventions | Liver Cancer Treatment Options Related Knowledge Scale | 84.6 score on a scale | Standard Deviation 13.3 |
| Description of Traditional Treatment Options | Liver Cancer Treatment Options Related Knowledge Scale | 75.6 score on a scale | Standard Deviation 6.8 |
Secondary
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.
Time frame: 1 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sharing Decision-making Program Interventions | Satisfaction With Decision Instrument | 26.2 score on a scale | Standard Deviation 2.2 |
| Description of Traditional Treatment Options | Satisfaction With Decision Instrument | 27.1 score on a scale | Standard Deviation 3.3 |
Other Pre-specified
Control Preference Scale
The scale is patients make treatment decisions in life-threatening conditions. For the first time, ask patients about their preferred clinical decision-making role. Then, ask a second time for the style they experienced. The instrument doesn't have any score on a scale. Each question was counted independently, the maximum is the number of participants in each group. the minimum is zero.
Time frame: 1 week
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Sharing Decision-making Program Interventions | Control Preference Scale | I hope that I have seriously considered the opinions of the doctor and let me make my own decisions | 13 Count of Participants |
| Sharing Decision-making Program Interventions | Control Preference Scale | I hope that the doctor and I together making decisions | 9 Count of Participants |
| Sharing Decision-making Program Interventions | Control Preference Scale | I hope that my doctor will make the final decision on the treatment | 6 Count of Participants |
| Sharing Decision-making Program Interventions | Control Preference Scale | I prefer my doctor to make all related treatment decisions | 7 Count of Participants |
| Description of Traditional Treatment Options | Control Preference Scale | I prefer my doctor to make all related treatment decisions | 7 Count of Participants |
| Description of Traditional Treatment Options | Control Preference Scale | I hope that I have seriously considered the opinions of the doctor and let me make my own decisions | 11 Count of Participants |
| Description of Traditional Treatment Options | Control Preference Scale | I hope that my doctor will make the final decision on the treatment | 5 Count of Participants |
| Description of Traditional Treatment Options | Control Preference Scale | I hope that the doctor and I together making decisions | 11 Count of Participants |
Other Pre-specified
Decision Regret Scale
The DRS was used to evaluate the feeling of regret after making a decision. There are 5 questions on the scale. The scoring of each situation is based on a Likert scale of 1-5 points (from strongly agree to strongly disagree) for each question. The score is subtracted by 1 and then multiplied by 25, so that each question may be scored 0-100 Minute. The final score is added and averaged. The score range is 0-100 points. The higher the score, the more regretful it is, the 0 point means no regret and 100 points means very regret.
Time frame: around 3 month after discharge
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sharing Decision-making Program Interventions | Decision Regret Scale | 20 score on a scale | Standard Deviation 12.2 |
| Description of Traditional Treatment Options | Decision Regret Scale | 22.4 score on a scale | Standard Deviation 13.5 |