Transarterial ChemoembolizationNCT07825519
Effectiveness of Enhanced Web-Based Health Education on Self-Care Practices and Quality of Life Among Patients With Hepatocellular Carcinoma Undergoing TACE
A study testing Enhanced Web-Based Health Education and Routine Health Education in people with Transarterial Chemoembolization and TACE(Transcatheter Arterial Chemoembolization), run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transarterial Chemoembolization, TACE(Transcatheter Arterial Chemoembolization), Web-based Intervention
- What is being tested?
- Enhanced Web-Based Health Education and Routine Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteVietnam
- Study dates
- 13 Sep 2024to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Enhanced Web-Based Health Education on Self-Care Practices and Quality of Life Among Patients With Hepatocellular Carcinoma
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.
- Conditions
- Transarterial Chemoembolization, TACE(Transcatheter Arterial Chemoembolization), Web-based Intervention, Quality of Life, Self-care, HCC - Hepatocellular Carcinoma
- Being tested
- Enhanced Web-Based Health Education, Routine Health Education
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Web-Based Health EducationBehavioural
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.
Routine Health EducationBehavioural
Participants in the control group will receive routine health education and printed educational materials according to usual care for patients undergoing TACE.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Enhanced Web-Based Health Education |
| Control Group | Active comparator | Not described Receives: Behavioral: Routine Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 1 month, and 3 months after TACE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2026
- Study start13 Sep 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Transarterial ChemoembolizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 252 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07825519
- Sponsor's protocol ID
- 123/GCN-HĐĐĐ
- Status last verified
- Sep 2026
- First submitted
- 13 Sep 2026
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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 35294089Fayers 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 11858978Arslan 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 31989907Marcacuzco 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 30082086Reig 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Enhanced Web-Based Health Education on Self-Care Practices and Quality of Life Among Patients With Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT07825519
- Acronym / sponsor ID
- 123/GCN-HĐĐĐ
- Conditions
- Transarterial Chemoembolization, TACE(Transcatheter Arterial Chemoembolization), Web-based Intervention, Quality of Life, Self-care, HCC - Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 252 participants (actual)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 13 Sep 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 17 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Enhanced Web-Based Health Education |
| Control Group | Active comparator | Behavioral: Routine Health Education |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- • 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.
Key exclusion criteria (3 listed)
- • Patients with HCC scheduled to undergo TACE who have diagnosed cognitive impairment due to neurological disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Web-Based Health EducationParticipants 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. | Behavioural | Intervention Group |
| Routine Health EducationParticipants in the control group will receive routine health education and printed educational materials according to usual care for patients undergoing TACE. | Behavioural | Control Group |
Primary outcome
Change in Knowledge Score
Time frame: Baseline, 1 month, and 3 months after TACE
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.
1 secondary outcome
Change in Self-Care Practice Score
Time frame: Baseline, 1 month, and 3 months after TACE
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Results publication: PubMed 35294089Zhang 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.
- Results publication: PubMed 11858978Fayers 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.
- Results publication: PubMed 31989907Arslan 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.
- Results publication: PubMed 30082086Marcacuzco 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.
- Results publication: PubMed 34801630Reig 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.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Web-Based Health Education and Routine Health Education in people with Transarterial Chemoembolization and TACE(Transcatheter Arterial Chemoembolization), run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Knowledge Score (time frame: Baseline, 1 month, and 3 months after TACE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07825519, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.