NCT07825519

Brief Summary

This randomized controlled trial aims to evaluate the effectiveness of enhanced web-based health education on self-care practices and quality of life among patients with hepatocellular carcinoma. A total of 252 participants undergoing transarterial chemoembolization (TACE) will be randomly assigned to an intervention group or a control group. The intervention group will receive routine health education combined with enhanced web-based health education, while the control group will receive routine health education and printed educational materials. Knowledge, self-care practices, and quality of life will be assessed at baseline, 1 month, and 3 months after TACE. The study will determine whether enhanced web-based health education can improve self-care practices and quality of life in patients with hepatocellular carcinoma undergoing TACE.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
252

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started Sep 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress64%
Sep 2024Dec 2027

Study Start

First participant enrolled

September 13, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2026

Completed
14 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2026

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Expected
Last Updated

September 17, 2026

Status Verified

September 1, 2026

Enrollment Period

2 years

First QC Date

September 13, 2026

Last Update Submit

September 13, 2026

Conditions

TACE(Transcatheter Arterial Chemoembolization)Web-based InterventionSelf-careHCC - Hepatocellular CarcinomaTransarterial ChemoembolizationQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Change in Knowledge Score

    Knowledge will be assessed using a 17-item researcher-developed questionnaire. Higher scores indicate better knowledge. The instrument was evaluated for content validity and demonstrated high internal consistency, with a Cronbach's alpha of 0.93.

    Baseline, 1 month, and 3 months after TACE

Secondary Outcomes (1)

  • Change in Self-Care Practice Score

    Baseline, 1 month, and 3 months after TACE

Other Outcomes (1)

  • Change in Quality of Life Scores

    Baseline, 1 month, and 3 months after TACE

Study Arms (2)

Intervention Group

EXPERIMENTAL
Behavioral: Enhanced Web-Based Health Education

Control Group

ACTIVE COMPARATOR
Behavioral: Routine Health Education

Interventions

Enhanced Web-Based Health EducationBEHAVIORAL

Participants in the intervention group will receive routine health education combined with an enhanced web-based health education program designed to support self-care among patients with hepatocellular carcinoma undergoing TACE. The web-based program provides educational content on hepatocellular carcinoma and TACE, preparation for TACE, post-TACE care, management of common symptoms, nutrition, medication adherence, warning signs, follow-up care, and self-care practices. Educational information is delivered through written materials, images, and videos and can be accessed by participants during the study period.

Intervention Group
Routine Health EducationBEHAVIORAL

Participants in the control group will receive routine health education and printed educational materials according to usual care for patients undergoing TACE.

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18 years or older who are diagnosed with hepatocellular carcinoma (HCC) and are scheduled to undergo Transarterial Chemoembolization (TACE) for the first time at the Department of Hepatobiliary and Pancreatic Surgery, University Medical Center Ho Chi Minh City.
  • Patients who agree to participate in the study and provide informed consent.

You may not qualify if:

  • Patients with HCC scheduled to undergo TACE who have diagnosed cognitive impairment due to neurological disorders.
  • Patients who are unable to understand spoken Vietnamese.
  • Patients with language or hearing impairments that interfere with communication and participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center

Ho Chi Minh City, Vietnam

Location

Related Publications (5)

  • Zhang X, Ma L, Feng L. Web-based self-management intervention for patients with cancer: A meta-analysis and systematic review. J Nurs Scholarsh. 2022 Sep;54(5):598-606. doi: 10.1111/jnu.12774. Epub 2022 Mar 16.

    PMID: 35294089RESULT

  • Fayers P, Bottomley A; EORTC Quality of Life Group; Quality of Life Unit. Quality of life research within the EORTC-the EORTC QLQ-C30. European Organisation for Research and Treatment of Cancer. Eur J Cancer. 2002 Mar;38 Suppl 4:S125-33. doi: 10.1016/s0959-8049(01)00448-8.

    PMID: 11858978RESULT

  • Arslan M, Degirmencioglu S. Risk Factors for Postembolization Syndrome After Transcatheter Arterial Chemoembolization. Curr Med Imaging Rev. 2019;15(4):380-385. doi: 10.2174/1573405615666181122145330.

    PMID: 31989907RESULT

  • Marcacuzco Quinto A, Nutu OA, San Roman Manso R, Justo Alonso I, Calvo Pulido J, Manrique Municio A, Garcia-Sesma A, Loinaz Segurola C, Martinez Caballero J, Jimenez Romero LC. Complications of transarterial chemoembolization (TACE) in the treatment of liver tumors. Cir Esp (Engl Ed). 2018 Nov;96(9):560-567. doi: 10.1016/j.ciresp.2018.06.004. Epub 2018 Aug 3. English, Spanish.

    PMID: 30082086RESULT

  • Reig M, Forner A, Rimola J, Ferrer-Fabrega J, Burrel M, Garcia-Criado A, Kelley RK, Galle PR, Mazzaferro V, Salem R, Sangro B, Singal AG, Vogel A, Fuster J, Ayuso C, Bruix J. BCLC strategy for prognosis prediction and treatment recommendation: The 2022 update. J Hepatol. 2022 Mar;76(3):681-693. doi: 10.1016/j.jhep.2021.11.018. Epub 2021 Nov 19.

    PMID: 34801630RESULT

Related Links

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. Both groups will be followed in parallel, with outcomes assessed at baseline, 1 month, and 3 months after TACE.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2026

First Posted

September 17, 2026

Study Start

September 13, 2024

Primary Completion

October 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

September 17, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF

Locations

VN(1)