Effects of Telephone Consultations on Discharged Liver Cancer

This study is currently recruiting participants.
Verified November 2012 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01595243
First received: April 4, 2012
Last updated: December 26, 2012
Last verified: November 2012
  Purpose

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.

Condition Intervention
Hepatocellular Carcinoma
Behavioral: telephone consultations about psychoeducation program

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Telephone Follow- up Consultations on Discharged Liver Cancer Following Non-surgical Treatment

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • quality of life [ Time Frame: 3 months after discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 254
Study Start Date: October 2009
Estimated Study Completion Date: February 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
patient with liver cancer in non-surgical treatment after discharge receive usual care
Experimental: patient in experiment
patient in the experimental group will receive seven instances of telephone follow-up or face to face education
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).

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01595243

Contacts
Contact: Shiow-ching Shun, PhD 886-2-23123456 ext 88439 scshun@ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan
Contact: Shiow-Ching Shun, Ph.D    886-2-2312-3456 ext 88439    scshun@ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Shiow-ching shun, PhD National Taiwan University
  More Information

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01595243     History of Changes
Other Study ID Numbers: 200908011R
Study First Received: April 4, 2012
Last Updated: December 26, 2012
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
hepatocellular carcinoma
Needs
Telephone consultation

Additional relevant MeSH terms:
Carcinoma
Liver Neoplasms
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Adenocarcinoma

ClinicalTrials.gov processed this record on April 15, 2014