Effects of Telephone Consultations on Discharged Liver Cancer

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01595243
Collaborator
(none)
254
1
2
58
4.4

Study Details

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 Phase
  • Behavioral: telephone consultations about psychoeducation program
N/A

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
Actual 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 :
Oct 1, 2009
Actual Primary Completion Date :
Jul 1, 2012
Actual Study Completion Date :
Aug 1, 2014

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. 12-Item Short Form Survey [3 months after discharge]

    Quality of life

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 National Taiwan University Hospital Taipei Taiwan

Sponsors and Collaborators

  • National Taiwan University Hospital

Investigators

  • Principal Investigator: Shiow-ching shun, PhD, National Taiwan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01595243
Other Study ID Numbers:
  • 200908011R
First Posted:
May 10, 2012
Last Update Posted:
Nov 16, 2020
Last Verified:
Nov 1, 2020
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 16, 2020