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Effectiveness of Telephone Intervention for Colorectal Cancer Caregivers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01519895
First Posted: January 27, 2012
Last Update Posted: April 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shum Nga Fan, Hospital Authority, Hong Kong
  Purpose
The purpose of this study is to assess the effectiveness of the telephone intervention program for caregivers of colorectal cancer.

Condition Intervention Phase
Psychological Stress Behavioral: Telephone intervention Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effectiveness of Telephone-based Intervention on Distress, Burden and Quality of Life of Chinese Caregivers of Colorectal Cancer Patients

Resource links provided by NLM:


Further study details as provided by Shum Nga Fan, Hospital Authority, Hong Kong:

Primary Outcome Measures:
  • 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 .


Secondary Outcome Measures:
  • 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

  • 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


Enrollment: 140
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Existing care
routine existing care
Experimental: Telephone intervention
in addition to provide telephone intervention support
Behavioral: Telephone intervention
counseling and education support

Detailed Description:
telephone Intervention refer to provide counseling and education to caregivers of colorectal cancer by mode of telephone
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01519895


Locations
China
Queen Mary Hospital
Hong Kong, China, 852
Sponsors and Collaborators
Hospital Authority, Hong Kong
Investigators
Principal Investigator: N F Shum Queen Mary Hospital, Hong Kong
  More Information

Responsible Party: Shum Nga Fan, Department of Surgery, Colorectal Specialist Nurse, Principal Investigator, Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier: NCT01519895     History of Changes
Other Study ID Numbers: HKCTR-1336
First Submitted: January 11, 2012
First Posted: January 27, 2012
Last Update Posted: April 15, 2015
Last Verified: April 2015

Keywords provided by Shum Nga Fan, Hospital Authority, Hong Kong:
quality of life
anxiety
stress
carers
colorectal or colon cancer

Additional relevant MeSH terms:
Colorectal Neoplasms
Stress, Psychological
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Behavioral Symptoms