Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effects of Telephone Consultations on Discharged Liver Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was  Recruiting
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

April 4, 2012
December 26, 2012
October 2009
July 2012   (final data collection date for primary outcome measure)
quality of life [ Time Frame: 3 months after discharge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01595243 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Effects of Telephone Consultations on Discharged Liver Cancer
Effects of Telephone Follow- up Consultations on Discharged Liver Cancer Following Non-surgical Treatment

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Hepatocellular Carcinoma
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).
  • 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
    Intervention: Behavioral: telephone consultations about psychoeducation program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
254
February 2013
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Shiow-ching Shun, PhD 886-2-23123456 ext 88439 scshun@ntu.edu.tw
Taiwan
 
NCT01595243
200908011R
Yes
National Taiwan University Hospital
National Taiwan University Hospital
Not Provided
Principal Investigator: Shiow-ching shun, PhD National Taiwan University
National Taiwan University Hospital
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP