Sharing Decision-making Program for HCC Patients Treatment Decisions

NCT ID: NCT03926039

Last Updated: 2021-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-01
• Study Completion Date: 2020-03-06

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) ).

Conditions

Hepatocellular Cancer

Keywords

Hepatocarcinoma; sharing decision-making; Health Literacy; decisional conflicts

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

sharing decision-making program

Intervention Type: BEHAVIORAL

Sharing decision-making talks and decision-making assistance tools used in the process

Description of traditional treatment options

Description of conventional traditional treatment options

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

sharing decision-making program

Sharing decision-making talks and decision-making assistance tools used in the process

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lotung Poh-Ai Hospital

OTHER

Sponsor Role: collaborator

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Tsae Jyy, Wang

RN PhD professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tsae Jyy Wang, PhD

Role: PRINCIPAL_INVESTIGATOR

National Taipei University of Nursing and Health Sciences

Locations

Lo-Hsu medical foundation Lotung Poh-Ai hospital

Yilan, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 9145723 (View on PubMed)

Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.

Reference Type: BACKGROUND

PMID: 9505581 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26795574 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26325281 (View on PubMed)

Liao YL, Wang TJ, Su CW, Liang SY, Liu CY, Fan JY. Efficacy of a Decision Support Intervention on Decisional Conflict Related to Hepatocellular Cancer Treatment: A Randomized Controlled Trial. Clin Nurs Res. 2023 Jan;32(1):233-243. doi: 10.1177/10547738221121447. Epub 2022 Sep 8.

Reference Type: DERIVED

PMID: 36082423 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CMUH108-REC3-002

Identifier Type: -

Identifier Source: org_study_id