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Active, not recruitingNCT07825519Updated Sep 17, 2026

Effectiveness of Enhanced Web-Based Health Education on Self-Care Practices and Quality of Life Among Patients With Hepatocellular Carcinoma Undergoing TACE

An interventional study of Enhanced Web-Based Health Education and Routine Health Education in Transarterial Chemoembolization, TACE(Transcatheter Arterial Chemoembolization) and Web-based Intervention, sponsored by University Medical Center Ho Chi Minh City (UMC). Active, not recruiting at 1 site in Vietnam. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by University Medical Center Ho Chi Minh City (UMC) · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
252
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Transarterial Chemoembolization
  • TACE(Transcatheter Arterial Chemoembolization)
  • Web-based Intervention
  • Quality of Life
  • Self-care
  • HCC - Hepatocellular Carcinoma
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

    • 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.

Exclusion criteria

Exclusion Criteria:

    • 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.
04

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
252 participants (actual)

Study arms

  • Experimental
    Intervention Group

    Behavioral: Enhanced Web-Based Health Education

  • Active comparator
    Control Group

    Behavioral: Routine Health Education

Interventions

  • BehavioralEnhanced Web-Based Health Education

    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.

  • BehavioralRoutine Health Education

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

05

What researchers measure

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.

    Time frame: Baseline, 1 month, and 3 months after TACE

Secondary outcomes

  1. Change in Self-Care Practice Score

    Self-care practices will be assessed using a 15-item researcher-developed questionnaire. Each item is rated on a 5-point Likert scale, with higher scores indicating better self-care practices. The instrument was evaluated for content validity and demonstrated acceptable internal consistency, with a Cronbach's alpha of 0.72.

    Time frame: Baseline, 1 month, and 3 months after TACE

Other outcomes

  1. Change in Quality of Life Scores

    Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30). The questionnaire consists of 30 items comprising five functional scales (physical, role, emotional, cognitive, and social functioning), three symptom scales (fatigue, nausea/vomiting, and pain), a global health status/quality of life scale, and six single-item symptom measures. Scores are transformed to a 0-100 scale according to the EORTC scoring procedures. Higher scores on the functional scales and global health status/quality of life scale indicate better functioning and quality of life, whereas higher scores on the symptom scales/items indicate greater symptom burden.

    Time frame: Baseline, 1 month, and 3 months after TACE

06

Study locations

1 site
  • University Medical Center
    Ho Chi Minh City, Vietnam
07

References and documents

Publications

  • 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. PubMed 35294089 ↗
  • 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. PubMed 11858978 ↗
  • 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. PubMed 31989907 ↗
  • 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. PubMed 30082086 ↗
  • 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. PubMed 34801630 ↗

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Sap, Icf

08

Registry details

Key details

Study ID
NCT07825519
Lead sponsor
University Medical Center Ho Chi Minh City (UMC)
Responsible party
Sponsor
First posted
Sep 17, 2026
Start date
Sep 13, 2024
Primary completion
Oct 1, 2026 (estimated)
Completion
Dec 1, 2027 (estimated)
Last update
Sep 17, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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