Trial Outcomes & Findings for Sharing Decision-making Program for HCC Patients Treatment Decisions (NCT NCT03926039)
NCT ID: NCT03926039
Last Updated: 2021-10-29
Results Overview
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.
COMPLETED
NA
70 participants
1 week
2021-10-29
Participant Flow
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
Participant milestones
| Measure |
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
|
Description of Traditional Treatment Options
Description of conventional traditional treatment options
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
35
|
|
Overall Study
COMPLETED
|
35
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sharing Decision-making Program for HCC Patients Treatment Decisions
Baseline characteristics by cohort
| Measure |
Sharing Decision-making Program Interventions
n=35 Participants
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 Traditional Treatment Options
n=34 Participants
Description of conventional traditional treatment options
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Age, Continuous
|
63.9 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
67.1 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
65.7 years
STANDARD_DEVIATION 12.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Region of Enrollment
Taiwan
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
BCLC stage
BCLC stage 0 (very early stage)
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
BCLC stage
BCLC stage A (early stage)
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
BCLC stage
BCLC stage B (intermediate stage)
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 week5 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.
Outcome measures
| Measure |
Sharing Decision-making Program Interventions
n=35 Participants
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 Traditional Treatment Options
n=34 Participants
Description of conventional traditional treatment options
|
|---|---|---|
|
Decisional Conflict Scale
|
6.9 score on a scale
Standard Deviation 9.7
|
11 score on a scale
Standard Deviation 14.3
|
SECONDARY outcome
Timeframe: 1 weekThe 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.
Outcome measures
| Measure |
Sharing Decision-making Program Interventions
n=35 Participants
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 Traditional Treatment Options
n=34 Participants
Description of conventional traditional treatment options
|
|---|---|---|
|
Satisfaction With Decision Instrument
|
26.2 score on a scale
Standard Deviation 2.2
|
27.1 score on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 1 weekThe 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
Outcome measures
| Measure |
Sharing Decision-making Program Interventions
n=35 Participants
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 Traditional Treatment Options
n=34 Participants
Description of conventional traditional treatment options
|
|---|---|---|
|
Decision Self-efficacy Scale
|
73.3 score on a scale
Standard Deviation 11.4
|
72.1 score on a scale
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: 1 weekA total of 20 questions total score of 100 points, the higher the knowledge, the better.Total scale range was 5-100 points.
Outcome measures
| Measure |
Sharing Decision-making Program Interventions
n=35 Participants
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 Traditional Treatment Options
n=34 Participants
Description of conventional traditional treatment options
|
|---|---|---|
|
Liver Cancer Treatment Options Related Knowledge Scale
|
84.6 score on a scale
Standard Deviation 13.3
|
75.6 score on a scale
Standard Deviation 6.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 1 weekThe 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.
Outcome measures
| Measure |
Sharing Decision-making Program Interventions
n=34 Participants
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 Traditional Treatment Options
n=34 Participants
Description of conventional 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
|
13 Count of Participants
|
11 Count of Participants
|
|
Control Preference Scale
I hope that the doctor and I together making decisions
|
9 Count of Participants
|
11 Count of Participants
|
|
Control Preference Scale
I hope that my doctor will make the final decision on the treatment
|
6 Count of Participants
|
5 Count of Participants
|
|
Control Preference Scale
I prefer my doctor to make all related treatment decisions
|
7 Count of Participants
|
7 Count of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: around 3 month after dischargeThe 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.
Outcome measures
| Measure |
Sharing Decision-making Program Interventions
n=35 Participants
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 Traditional Treatment Options
n=34 Participants
Description of conventional traditional treatment options
|
|---|---|---|
|
Decision Regret Scale
|
20 score on a scale
Standard Deviation 12.2
|
22.4 score on a scale
Standard Deviation 13.5
|
Adverse Events
Sharing Decision-making Program Interventions
Description of Traditional Treatment Options
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Director of Nursing Department
National Taipei University of Nursing and Health Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place