Effectiveness of Telephone Intervention for Colorectal Cancer Caregivers

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2012 by Hospital Authority, Hong Kong.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Shum Nga Fan, Hospital Authority, Hong Kong
ClinicalTrials.gov Identifier:
NCT01519895
First received: January 11, 2012
Last updated: January 24, 2012
Last verified: January 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Effect of telephone intervention at pre-discharged(base-line) and 2 weeks and 4 weeks and 8 weeks post intervention


Estimated Enrollment: 140
Study Start Date: June 2011
Estimated Study Completion Date: December 2012
Estimated 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 Behavioral: Telephone intervention
support

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01519895

Contacts
Contact: N F SHUM 2255-1253 ext 3724 shumnf@ha.org.hk

Locations
China, Hong Kong Special Administrative Region
Queen Mary Hospital Recruiting
Hong Kong, Hong Kong Special Administrative Region, China, 852
Contact: N F Shum    22551253 ext 22553724    shumnf@ha.org.hk   
Sponsors and Collaborators
Hospital Authority, Hong Kong
Investigators
Principal Investigator: N F Shum Queen Mary Hospital, Hong Kong
  More Information

No publications provided

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
Study First Received: January 11, 2012
Last Updated: January 24, 2012
Health Authority: Hong Kong: Ethics Committee

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

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

ClinicalTrials.gov processed this record on September 16, 2014