Effects of Telephone Consultations on Discharged Liver Cancer

Hepatocellular Carcinoma Clinical Trial

Official title:

Effects of Telephone Follow- up Consultations on Discharged Liver Cancer Following Non-surgical Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01595243
• Other study ID #: 200908011R
• Status: Completed
• Phase: N/A
• Start date: October 2009
• Est. completion date: August 2014

Study information

• Verified date: November 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aims of this three-year study are to:

1. From patients and family perspective to explore the needs for home care after receiving TACE, PEI, and RFA

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.

Description:

In the first year, a longitudinal mixed method with quantitative and qualitative method will be used. The Distress Management Tool, the Hospital Anxiety and Depression Scale, and the Short Form-12 quality of life will be used to assess patients' care needs, anxiety, depression, and quality of life in the quantitative method. Data will be analyzed by descriptive, Pearson's Correlation, and Stepwise Regression for each time point. Tape-recorded and in-depth interviews with semi-structured interview guidelines will be used in qualitative method to interview the cancer patients who are scheduled to be discharged after treatment. Content analysis will be used to analyze the interview content.

In the second and third year, randomized control trial will be used to recruit eligible subjects from inpatients in oncology wards in one medical center in Taipei. The eligible subjects will be randomized into a control or experimental group. The patients in the control group will receive usual care and those in the 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).Data will be analyzed by independent t-test, one-way analysis of variance, and generalized estimating equations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 254
• Est. completion date: August 2014
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with liver cancer in non-surgical treatment

• Aged above 18

• Those who are wiling to participate in the research

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Liver Neoplasms

Intervention

Behavioral:
• telephone consultations about psychoeducation program
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).

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-Item Short Form Survey	Quality of life	3 months after discharge