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Effects of Telephone Consultations on Discharged Liver Cancer

Primary Purpose

Hepatocellular Carcinoma

Status

Completed

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

telephone consultations about psychoeducation program

About this trial

This is an interventional supportive care trial for Hepatocellular Carcinoma focused on measuring hepatocellular carcinoma, Needs, Telephone consultation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

patient in experiment

Arm Description

patient with liver cancer in non-surgical treatment after discharge receive usual care

patient in the experimental group will receive seven instances of telephone follow-up or face to face education

Outcomes

Primary Outcome Measures

12-Item Short Form Survey

Quality of life

Secondary Outcome Measures

Full Information

NCT ID

NCT01595243

First Posted

April 4, 2012

Last Updated

November 12, 2020

Sponsor

National Taiwan University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01595243

Brief Title

Effects of Telephone Consultations on Discharged Liver Cancer

Official Title

Effects of Telephone Follow- up Consultations on Discharged Liver Cancer Following Non-surgical Treatment

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

July 2012 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Taiwan University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

Keywords

hepatocellular carcinoma, Needs, Telephone consultation

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

254 (Actual)

8. Arms, Groups, and Interventions

Arm Title

control

Arm Type

No Intervention

Arm Description

patient with liver cancer in non-surgical treatment after discharge receive usual care

Arm Title

patient in experiment

Arm Type

Experimental

Arm Description

patient in the experimental group will receive seven instances of telephone follow-up or face to face education

Intervention Type

Behavioral

Intervention Name(s)

telephone consultations about psychoeducation program

Intervention Description

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).

Primary Outcome Measure Information:

Title

12-Item Short Form Survey

Description

Quality of life

Time Frame

3 months after discharge

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shiow-ching shun, PhD

Organizational Affiliation

National Taiwan University

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Taiwan University Hospital

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

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Effects of Telephone Consultations on Discharged Liver Cancer

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