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Sharing Decision-making Program for HCC Patients Treatment Decisions

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ClinicalTrials.gov Identifier: NCT03926039
Recruitment Status : Recruiting
First Posted : April 24, 2019
Last Update Posted : February 26, 2020
Sponsor:
Collaborator:
Lotung Poh-Ai Hospital
Information provided by (Responsible Party):
Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences

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 Not Applicable

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) ).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 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)
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 : February 13, 2019
Estimated Primary Completion Date : October 31, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

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



Primary Outcome Measures :
  1. 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.

  2. control preference scale [ Time Frame: 1 week ]
    Nominal variable, 1 point is make a decision by participant ,2 point is Seriously consider the doctor's opinion, and then make the decision about the treatment participant, and 3 point is the individual will make a decision together with the doctor. 4 point is My doctor will make the final decision on the treatment and must seriously consider my opinion and 5 point make a decision by the doctor.

  3. 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. total score were 0 to 1600 points.

  4. 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

  5. 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.

  6. Decision Regret Scale [ Time Frame: 3 months later ]
    There are 5 questions in the content of the scale. The scoring of each situation is scored on the Likert scale with 0-4 points (very agree and very disagree) for each question. The first question, the third question and the fifth question are The forward question, in which the second and fourth questions are reverse questions, need to be scored in reverse, then multiplied by 25, so that each question may score 0-100 points. The higher the score, the more regret it is. Total score is 0-500 points.



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926039


Contacts
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Contact: Tsae Jyy Wang, PhD +8869112461360 tsaejyy@mtumhs.edu.tw
Contact: Yueh-Ling Liao, master +8860972200072 q868069@gmail.com

Locations
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Taiwan
Lo-Hsu medical foundation Lotung Poh-Ai hospital Recruiting
Yilan, Taiwan, 265
Contact: Tzeng-hue Yang, University    039543131    848034@mail.pohai.org.tw   
Principal Investigator: Tzeng-hue Yang, University         
Sponsors and Collaborators
National Taipei University of Nursing and Health Sciences
Lotung Poh-Ai Hospital
Investigators
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Principal Investigator: Tsae Jyy Wang, PhD National Taipei University of Nursing and Health Sciences
Publications:
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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: April 24, 2019    Key Record Dates
Last Update Posted: February 26, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tsae Jyy, Wang, National Taipei University of Nursing and Health Sciences:
Hepatocarcinoma
sharing decision-making
Health Literacy
decisional conflicts
Additional relevant MeSH terms:
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Liver Neoplasms
Carcinoma, Hepatocellular
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type