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Sharing Decision-making Program for HCC Patients Treatment Decisions

  • Clinicaltrials.gov identifier

    NCT03926039

  • Recruitment Status

    Completed

  • First Posted

    April 24, 2019

  • Result First Posted

    April 15, 2021

  • Last update posted

    April 15, 2021

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:Hepatocellular Cancer
  • Intervention/Treatment: Behavioral: sharing decision-making program
  • Phase: 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.
  • Masking: Single (Participant)
  • 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: February 2019
  • Actual Primary Completion Date: March 2020
  • Actual Study Completion Date: March 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

Outcome Measures

  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. Satisfaction With Decision Instrument [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.

Eligibility Criteria

  • Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts

Locations

Taiwan
Lo-Hsu medical foundation Lotung Poh-Ai hospital
Yilan

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

More Information

  • Study Type: Interventional
  • Study Design: Allocation: Randomized;Intervention Model: Parallel Assignment;Masking: Single;Primary Purpose: Other
  • Condition: Hepatocellular Cancer
  • Interventions : Behavioral: sharing decision-making program
  • Enrollment: 70

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
  • Pre-assignment Details

  • Arm/Group title Description of Traditional Treatment Options Sharing Decision-making Program Interventions
  • Arm/Group Description Description of conventional traditional treatment options 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
    Period Title: Overall Study
  • Started 35 35
  • Completed 34 35
  • Not Completed 1 0
  • Reason Not Completed
Baseline Characteristics
  • Arm/Group title TotalDescription of Traditional Treatment OptionsSharing Decision-making Program Interventions
  • Arm/Group Description Total of all reporting groupsDescription of conventional traditional treatment optionsDescription 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
  • Overall Number of Baseline Participants 693435
  • Baseline Analysis Population Description A total of 72 people are eligible for recruitment criteria. One person was transferred to the medical center hospital and refused to participate. Another person did not know the condition and therefore excluded. A total of 70 participants randomly allocated to the intervention group and control group. There is one participant who was a dropout due to go to a medical center for surgery. The effective sample was 69.
  • Region of Enrollment Measure Type: Count of Participants Unit of Measure: Participants Number Analyzed 69 Participants34 Participants35 Participants
Outcome Measures

1. PrimaryOutcome

  • 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 Description of Traditional Treatment OptionsSharing Decision-making Program Interventions
  • Arm/Group Description Description of conventional traditional treatment optionsDescription 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
  • Overall Number of Participants Analyzed 3435
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: score on a scale
  • 11
    6.9
  • Statistical Analysis Overview
    • Comparison Group Selection Decisional Conflict Scale
    • 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. SecondaryOutcome

  • 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 Description of Traditional Treatment OptionsSharing Decision-making Program Interventions
  • Arm/Group Description Description of conventional traditional treatment optionsDescription 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
  • Overall Number of Participants Analyzed 3435
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: score on a scale
  • 75.6
    84.6

3. SecondaryOutcome

  • 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 Description of Traditional Treatment OptionsSharing Decision-making Program Interventions
  • Arm/Group Description Description of conventional traditional treatment optionsDescription 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
  • Overall Number of Participants Analyzed 3435
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: score on a scale
  • 72.1
    73.3

4. SecondaryOutcome

  • 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 Description of Traditional Treatment OptionsSharing Decision-making Program Interventions
  • Arm/Group Description Description of conventional traditional treatment optionsDescription 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
  • Overall Number of Participants Analyzed 3435
  • Measure Type: Mean (Standard Deviation)
    Unit of Measure: score on a scale
  • 27.1
    26.2
Adverse Events
  • Time Frame
  • Adverse Event Reporting Description
  •  
  • Arm/Group Title
  • Arm/Group Description

Limitations and 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.

Results Point of Contact

  • Name/Title:Director of Nursing Department
  • Organization:National Taipei University of Nursing and Health Sciences
  • Phone:886-2-28712121 ext 3100
  • EMail:tsaejyy@ntunhs.edu.tw
  • ClinicalTrials.gov Identifier: NCT03926039 History of Changes
  • Other Study ID Numbers: CMUH108-REC3-002
  • First Submitted: April 16, 2019
  • First Posted: April 24, 2019
  • Results First Submitted: February 23, 2021
  • Results First Posted: April 15, 2021
  • Last Update Posted: April 15, 2021