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Effects of Telephone Consultations on Discharged Liver Cancer

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ClinicalTrials.gov Identifier: NCT01595243
Recruitment Status : Unknown
Verified November 2012 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : May 10, 2012
Last Update Posted : December 27, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

Condition or disease Intervention/treatment
Hepatocellular Carcinoma Behavioral: telephone consultations about psychoeducation program

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 254 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Telephone Follow- up Consultations on Discharged Liver Cancer Following Non-surgical Treatment
Study Start Date : October 2009
Primary Completion Date : July 2012
Estimated Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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).


Outcome Measures

Primary Outcome Measures :
  1. quality of life [ Time Frame: 3 months after discharge ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT01595243     History of Changes
Other Study ID Numbers: 200908011R
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: December 27, 2012
Last Verified: November 2012

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

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