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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01519895
Other study ID # HKCTR-1336
Secondary ID
Status Completed
Phase Phase 2
First received January 11, 2012
Last updated April 14, 2015
Start date June 2011
Est. completion date December 2012

Study information

Verified date April 2015
Source Hospital Authority, Hong Kong
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the effectiveness of the telephone intervention program for caregivers of colorectal cancer.


Description:

telephone Intervention refer to provide counseling and education to caregivers of colorectal cancer by mode of telephone


Recruitment information / eligibility

Status Completed
Enrollment 140
Est. completion date December 2012
Est. primary completion date August 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Behavioral:
Telephone intervention
counseling and education support

Locations

Country Name City State
China Queen Mary Hospital Hong Kong

Sponsors (1)

Lead Sponsor Collaborator
Hospital Authority, Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 . Change of distress level at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention No
Secondary 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 Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention No
Secondary Quality of life Effect of telephone intervention at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention No
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