Effectiveness of Telephone Intervention for Colorectal Cancer Caregivers

April 14, 2015 updated by: Shum Nga Fan, Hospital Authority, Hong Kong

Effectiveness of Telephone-based Intervention on Distress, Burden and Quality of Life of Chinese Caregivers of Colorectal Cancer Patients

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Hong Kong, China, 852
        • Queen Mary Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Existing care
routine existing care
Experimental: Telephone intervention
in addition to provide telephone intervention support
Behavioral: Telephone intervention
counseling and education support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distress level
Time Frame: Change of distress level at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Burden of care
Time Frame: Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
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
Quality of life
Time Frame: Measured at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Authority, Hong Kong

Investigators

  • Principal Investigator: N F Shum, Queen Mary Hospital, Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

January 24, 2012

First Posted (Estimate)

January 27, 2012

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKCTR-1336

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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