NCT01595243

Brief Summary

The aims of this three-year study are to:

  1. 1.From patients and family perspective to explore the needs for home care after receiving TACE, PEI, and RFA
  2. 2.Develop a telephone follow-up and consultation program and examine its effect on self-efficacy, anxiety, depression and quality of life in liver cancer patients receiving non-surgical treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
254

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
Completed

Started Oct 2009

Typical duration for not_applicable hepatocellular-carcinoma

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

Study Start

First participant enrolled

October 1, 2009

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 10, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

November 16, 2020

Status Verified

November 1, 2020

Enrollment Period

2.8 years

First QC Date

April 4, 2012

Last Update Submit

November 12, 2020

Conditions

Hepatocellular Carcinoma

Keywords

hepatocellular carcinomaNeedsTelephone consultation

Outcome Measures

Primary Outcomes (1)

  • 12-Item Short Form Survey

    Quality of life

    3 months after discharge

Study Arms (2)

control

NO INTERVENTION

patient with liver cancer in non-surgical treatment after discharge receive usual care

patient in experiment

EXPERIMENTAL

patient in the experimental group will receive seven instances of telephone follow-up or face to face education

Behavioral: telephone consultations about psychoeducation program

Interventions

telephone consultations about psychoeducation programBEHAVIORAL

experimental group will receive seven instances of telephone follow-up or face-to-face education (the day before discharge and during the first, second, third, fourth, sixth, and eighth weeks after discharge).

patient in experiment

Eligibility Criteria

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

You may qualify if:

  • Patients with liver cancer in non-surgical treatment
  • Aged above 18
  • Those who are wiling to participate in the research

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

  • Shiow-ching shun, PhD

    National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2012

First Posted

May 10, 2012

Study Start

October 1, 2009

Primary Completion

July 1, 2012

Study Completion

August 1, 2014

Last Updated

November 16, 2020

Record last verified: 2020-11

Locations

TW(1)