Back to resultsEffectiveness of Telephone Intervention for Colorectal Cancer Caregivers
Primary Purpose
Psychological Stress
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Telephone intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Psychological Stress focused on measuring quality of life, anxiety, stress, carers, colorectal or colon cancer
Eligibility Criteria
Inclusion Criteria:
- Family members with newly diagnosed colorectal cancer within the past 4 week and treated in Queen Mary Hospital
- Self identified as formal or informal family caregivers
- Over 18 years old
- Chinese
- Cantonese speaking
Exclusion Criteria:
- Cognitive disability
- Domestic helpers or maids
- Non Chinese
Sites / Locations
- Queen Mary Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Existing care
Telephone intervention
Arm Description
routine existing care
in addition to provide telephone intervention support
Outcomes
Primary Outcome Measures
Distress level
Effect of telephone intervention on distress level measured at pre-discharged(baseline) and 2 weeks and 4 weeks and 8 weeks post intervention .
Secondary Outcome Measures
Burden of care
Effect of telephone intervention on burden of care measured at pre-discharged(baseline) and 2 weeks and 4 weeks and 8 weeks post intervention
Quality of life
Effect of telephone intervention at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
Full Information
NCT ID
NCT01519895
First Posted
January 11, 2012
Last Updated
April 14, 2015
Sponsor
Hospital Authority, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01519895
Brief Title
Effectiveness of Telephone Intervention for Colorectal Cancer Caregivers
Official Title
Effectiveness of Telephone-based Intervention on Distress, Burden and Quality of Life of Chinese Caregivers of Colorectal Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Authority, Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to assess the effectiveness of the telephone intervention program for caregivers of colorectal cancer.
Detailed Description
telephone Intervention refer to provide counseling and education to caregivers of colorectal cancer by mode of telephone
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychological Stress
Keywords
quality of life, anxiety, stress, carers, colorectal or colon cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Existing care
Arm Type
No Intervention
Arm Description
routine existing care
Arm Title
Telephone intervention
Arm Type
Experimental
Arm Description
in addition to provide telephone intervention support
Intervention Type
Behavioral
Intervention Name(s)
Telephone intervention
Intervention Description
counseling and education support
Primary Outcome Measure Information:
Title
Distress level
Description
Effect of telephone intervention on distress level measured at pre-discharged(baseline) and 2 weeks and 4 weeks and 8 weeks post intervention .
Time Frame
Change of distress level at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
Secondary Outcome Measure Information:
Title
Burden of care
Description
Effect of telephone intervention on burden of care measured at pre-discharged(baseline) and 2 weeks and 4 weeks and 8 weeks post intervention
Time Frame
Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
Title
Quality of life
Description
Effect of telephone intervention at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
Time Frame
Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Family members with newly diagnosed colorectal cancer within the past 4 week and treated in Queen Mary Hospital
Self identified as formal or informal family caregivers
Over 18 years old
Chinese
Cantonese speaking
Exclusion Criteria:
Cognitive disability
Domestic helpers or maids
Non Chinese
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
N F Shum
Organizational Affiliation
Queen Mary Hospital, Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
ZIP/Postal Code
852
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effectiveness of Telephone Intervention for Colorectal Cancer Caregivers
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