Sharing Decision-making Program for HCC Patients Treatment Decisions

• Sponsor: National Taipei University of Nursing and Health Sciences (Other)
• Overall Status: Completed
• CT.gov ID: NCT03926039
• Collaborator: Lotung Poh-Ai Hospital (Other)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 10.2
• Patients Per Site Per Month: 6.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Cancer	Behavioral: sharing decision-making program	N/A

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

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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.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 (Participant)
• 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.
• Primary Purpose: Other
• 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
• Actual Study Start Date: May 1, 2019
• Actual Primary Completion Date: Mar 6, 2020
• Actual Study Completion Date: Mar 6, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: sharing decision-making program; Sharing decision-making talks and decision-making assistance tools used in the process
No Intervention: Description of traditional treatment options Description of conventional traditional treatment options

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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.

2. 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

3. 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 Outcome Measures

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lo-Hsu medical foundation Lotung Poh-Ai hospital	Yilan		Taiwan	265

Sponsors and Collaborators

• National Taipei University of Nursing and Health Sciences
• Lotung Poh-Ai Hospital

Investigators

• Principal Investigator: Tsae Jyy Wang, PhD, National Taipei University of Nursing and Health Sciences

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 16, 2021

More Information

Publications

• Bruix 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. Review.
• 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.
• Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
• Katie 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.

• Responsible Party: Tsae Jyy, Wang, RN PhD professor, National Taipei University of Nursing and Health Sciences
• ClinicalTrials.gov Identifier: NCT03926039
• Other Study ID Numbers: CMUH108-REC3-002
• First Posted: Apr 24, 2019
• Last Update Posted: Oct 29, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tsae Jyy, Wang, RN PhD professor, National Taipei University of Nursing and Health Sciences: Hepatocarcinoma; sharing decision-making; Health Literacy; decisional conflicts
• Additional relevant MeSH terms: Liver Neoplasms; Carcinoma, Hepatocellular

Study Results

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

Arm/Group Title	Sharing Decision-making Program Interventions	Description of Traditional Treatment Options
Arm/Group Description	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	Description of conventional traditional treatment options
Period Title: Overall Study
STARTED	35	35
COMPLETED	35	34
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Sharing Decision-making Program Interventions	Description of Traditional Treatment Options	Total
Arm/Group Description	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	Description of conventional traditional treatment options	Total of all reporting groups
Overall Participants	35	34	69
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	17 48.6%	16 47.1%	33 47.8%
>=65 years	18 51.4%	18 52.9%	36 52.2%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	63.9 (11.3)	67.1 (13.5)	65.7 (12.5)
Sex: Female, Male (Count of Participants)
Female	11 31.4%	12 35.3%	23 33.3%
Male	24 68.6%	22 64.7%	46 66.7%
Race/Ethnicity, Customized (Count of Participants)
Asian	35 100%	34 100%	69 100%
Region of Enrollment (Count of Participants)
Taiwan	35 100%	34 100%	69 100%
BCLC stage (Count of Participants)
BCLC stage 0 (very early stage)	12 34.3%	14 41.2%	26 37.7%
BCLC stage A (early stage)	19 54.3%	14 41.2%	33 47.8%
BCLC stage B (intermediate stage)	4 11.4%	6 17.6%	10 14.5%

Outcome Measures

1. Primary Outcome

Title	Decisional Conflict Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sharing Decision-making Program Interventions	Description of Traditional Treatment Options
Arm/Group Description	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	Description of conventional traditional treatment options
Measure Participants	35	34
Mean (Standard Deviation) [score on a scale]	6.9 (9.7)	11 (14.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Sharing Decision-making Program Interventions, Description of Traditional Treatment Options
	Comments	Both group of average difference (95% CI) in intervention group and control group
	Type of Statistical Test	Equivalence
	Comments	Equivalence Analysis
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	ANOVA
	Comments

2. Secondary Outcome

Title	Satisfaction With Decision Instrument
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sharing Decision-making Program Interventions	Description of Traditional Treatment Options
Arm/Group Description	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	Description of conventional traditional treatment options
Measure Participants	35	34
Mean (Standard Deviation) [score on a scale]	26.2 (2.2)	27.1 (3.3)

3. Secondary Outcome

Title	Decision Self-efficacy Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sharing Decision-making Program Interventions	Description of Traditional Treatment Options
Arm/Group Description	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	Description of conventional traditional treatment options
Measure Participants	35	34
Mean (Standard Deviation) [score on a scale]	73.3 (11.4)	72.1 (15.6)

4. Secondary Outcome

Title	Liver Cancer Treatment Options Related Knowledge Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sharing Decision-making Program Interventions	Description of Traditional Treatment Options
Arm/Group Description	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	Description of conventional traditional treatment options
Measure Participants	35	34
Mean (Standard Deviation) [score on a scale]	84.6 (13.3)	75.6 (6.8)

5. Other Pre-specified Outcome

Title	Control Preference Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sharing Decision-making Program Interventions	Description of Traditional Treatment Options
Arm/Group Description	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	Description of conventional traditional treatment options
Measure Participants	34	34
I hope that I have seriously considered the opinions of the doctor and let me make my own decisions	13 37.1%	11 32.4%
I hope that the doctor and I together making decisions	9 25.7%	11 32.4%
I hope that my doctor will make the final decision on the treatment	6 17.1%	5 14.7%
I prefer my doctor to make all related treatment decisions	7 20%	7 20.6%

6. Other Pre-specified Outcome

Title	Decision Regret Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sharing Decision-making Program Interventions	Description of Traditional Treatment Options
Arm/Group Description	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	Description of conventional traditional treatment options
Measure Participants	35	34
Mean (Standard Deviation) [score on a scale]	20 (12.2)	22.4 (13.5)

Adverse Events

Time Frame	around 3 month
Arm/Group Title	Sharing Decision-making Program Interventions		Description of Traditional Treatment Options
Arm/Group Description	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		Description of conventional traditional treatment options
All Cause Mortality
	Sharing Decision-making Program Interventions		Description of Traditional Treatment Options
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/34 (0%)
Serious Adverse Events
	Sharing Decision-making Program Interventions		Description of Traditional Treatment Options
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/34 (0%)
Other (Not Including Serious) Adverse Events
	Sharing Decision-making Program Interventions		Description of Traditional Treatment Options
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/35 (0%)		0/34 (0%)

Limitations/Caveats

The participants' average age of onset was 65 years old, and the education level was below the elementary school. Some cases need to be read verbatim and assisted in checking. , Maybe slightly different from the self-reading, but the researchers still try to be neutral and consistent when reading the questionnaire, so as not to affect the participants' answers

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.