NCT03926039

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 16, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
7 days until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 6, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 6, 2020

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

April 15, 2021

Completed
Last Updated

October 29, 2021

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

April 16, 2019

Results QC Date

February 23, 2021

Last Update Submit

October 27, 2021

Conditions

Hepatocellular Cancer

Keywords

Hepatocarcinomasharing decision-makingHealth Literacydecisional conflicts

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 week

Secondary Outcomes (3)

  • Satisfaction With Decision Instrument

    1 week

  • Decision Self-efficacy Scale

    1 week

  • Liver Cancer Treatment Options Related Knowledge Scale

    1 week

Other Outcomes (2)

  • Control Preference Scale

    1 week

  • Decision Regret Scale

    around 3 month after discharge

Study Arms (2)

sharing decision-making program interventions

EXPERIMENTAL

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

Description of traditional treatment options

NO INTERVENTION

Description of conventional traditional treatment options

Interventions

sharing decision-making programBEHAVIORAL

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

sharing decision-making program interventions

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Don't know himself condition.
  • Unconscious patients.
  • Patients with liver cancer resection or partial liver resection were performed within 3 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lo-Hsu medical foundation Lotung Poh-Ai hospital

Yilan, 265, Taiwan

Location

Related Publications (5)

  • 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.

    PMID: 9145723BACKGROUND

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

    PMID: 9505581BACKGROUND

  • 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.

    PMID: 26795574BACKGROUND

  • 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.

    PMID: 26325281BACKGROUND

  • 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.

    PMID: 36082423DERIVED

MeSH Terms

Conditions

Liver NeoplasmsCarcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesLiver DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Limitations and Caveats

The participants' average age of onset was 65 years old, and the education level was below the elementary school. Some cases need to be read verbatim and assisted in checking. , Maybe slightly different from the self-reading, but the researchers still try to be neutral and consistent when reading the questionnaire, so as not to affect the participants' answers

Results Point of Contact

Title
Director of Nursing Department
Organization
National Taipei University of Nursing and Health Sciences
tsaejyy@ntunhs.edu.tw
886-2-28712121

Study Officials

  • Tsae Jyy Wang, PhD

    National Taipei University of Nursing and Health Sciences

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
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.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
RN PhD professor

Study Record Dates

First Submitted

April 16, 2019

First Posted

April 24, 2019

Study Start

May 1, 2019

Primary Completion

March 6, 2020

Study Completion

March 6, 2020

Last Updated

October 29, 2021

Results First Posted

April 15, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)