- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01595243
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:
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taipei, Taiwan
- National Taiwan University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
12-Item Short Form Survey
Time Frame: 3 months after discharge
|
Quality of life
|
3 months after discharge
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 200908011R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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