Effects of Telephone Consultations on Discharged Liver Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01595243|
Recruitment Status : Completed
First Posted : May 10, 2012
Last Update Posted : November 16, 2020
The aims of this three-year study are to:
- From patients and family perspective to explore the needs for home care after receiving TACE, PEI, and RFA
- 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||Phase|
|Hepatocellular Carcinoma||Behavioral: telephone consultations about psychoeducation program||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||254 participants|
|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|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||August 2014|
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).
- 12-Item Short Form Survey [ Time Frame: 3 months after discharge ]Quality of life
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
|National Taiwan University Hospital|
|Principal Investigator:||Shiow-ching shun, PhD||National Taiwan University|