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Sharing Decision-making Program for HCC Patients Treatment Decisions

Primary Purpose

Hepatocellular Cancer

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
sharing decision-making program
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hepatocellular Cancer focused on measuring Hepatocarcinoma, sharing decision-making, Health Literacy, decisional conflicts

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lo-Hsu medical foundation Lotung Poh-Ai hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

sharing decision-making program interventions

Description of traditional treatment options

Arm 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.

Description of conventional traditional treatment options

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
April 16, 2019
Last Updated
October 27, 2021
Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Lotung Poh-Ai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03926039
Brief Title
Sharing Decision-making Program for HCC Patients Treatment Decisions
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2019 (Actual)
Primary Completion Date
March 6, 2020 (Actual)
Study Completion Date
March 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences
Collaborators
Lotung Poh-Ai Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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) ).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Cancer
Keywords
Hepatocarcinoma, sharing decision-making, Health Literacy, decisional conflicts

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
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.
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sharing decision-making program interventions
Arm Type
Experimental
Arm 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.
Arm Title
Description of traditional treatment options
Arm Type
No Intervention
Arm Description
Description of conventional traditional treatment options
Intervention Type
Behavioral
Intervention Name(s)
sharing decision-making program
Intervention Description
Sharing decision-making talks and decision-making assistance tools used in the process
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
Other Pre-specified Outcome Measures:
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Don't know himself condition. Unconscious patients. Patients with liver cancer resection or partial liver resection were performed within 3 months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tsae Jyy Wang, PhD
Organizational Affiliation
National Taipei University of Nursing and Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lo-Hsu medical foundation Lotung Poh-Ai hospital
City
Yilan
ZIP/Postal Code
265
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9145723
Citation
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.
Results Reference
background
PubMed Identifier
9505581
Citation
Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
Results Reference
background
PubMed Identifier
26795574
Citation
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.
Results Reference
background
PubMed Identifier
26325281
Citation
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.
Results Reference
background

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Sharing Decision-making Program for HCC Patients Treatment Decisions

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