Clinical trial NCT03926039: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hepatocellular Cancer
Keywords: Hepatocarcinoma
sharing decision-making
Health Literacy
decisional conflicts
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Lotung Poh-Ai Hospital
First posted: 2019-04-24
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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) ).

Eligibility 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.

Primary outcomes:
measure: Decisional Conflict Scale
timeFrame: 1 week
Secondary outcomes:
measure: Satisfaction With Decision Instrument
timeFrame: 1 week
measure: Decision Self-efficacy Scale
timeFrame: 1 week
measure: Liver Cancer Treatment Options Related Knowledge Scale
timeFrame: 1 week
Other outcomes:
measure: Control Preference Scale
timeFrame: 1 week
measure: Decision Regret Scale
timeFrame: around 3 month after discharge
Locations:
city: Yilan
country: Taiwan
facility: Lo-Hsu medical foundation Lotung Poh-Ai hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Tsae Jyy Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
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.
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.