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The Efficacy of the Caregiver Psychoeducational Consultation Program

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT01001884
First received: October 21, 2009
Last updated: August 12, 2010
Last verified: June 2010
History of Changes
  Purpose

Aim:

To examine the effects of the caregiver psychoeducational consultation program in reducing caregiver burdens, depression, sleep quality, and improving the experience in close relationship, positive meaning of illness and quality of life.

This is the 2-year study. The design adopts the randomized controlled trial (RCT). The caregivers of patients with spouse caregivers of resectable metastatic colorectal cancer will be randomly assigned into two groups: one group receiving usual care, another group receiving the caregiver psychoeducational consultation program (CPCP). The usual care includes providing education materials only. Measurement time-points include pre intervention, post intervention, & then 1, and 3 months after the end of intervention for the maintenance effect.


Condition Intervention Phase
Depression
Sleep
 Other: caregiver psychoeducational consultation program (CPCP)
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Supportive Care
Official Title: The Efficacy of the Caregiver Psychoeducational Consultation Program in Spouse Caregivers of Resectable Colorectal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Short-form 12 health-related quality of life questionnaire [ Time Frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Caregiver reaction assessment [ Time Frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions ] [ Designated as safety issue: Yes ]
  • Experiences in close relationships scale [ Time Frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions ] [ Designated as safety issue: Yes ]
  • Moss sleeping scale [ Time Frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions ] [ Designated as safety issue: Yes ]
  • BDI-II depression scale [ Time Frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: February 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: counseling
caregiver psychoeducational consultation program (CPCP)
 Other: caregiver psychoeducational consultation program (CPCP)
6-session caregiver psychoeducational consultation program (CPCP)
Other Name: consultation

Detailed Description:

To examine the effects of the caregiver psychoeducational consultation program in reducing caregiver burdens, depression, sleep quality, and improving the experience in close relationship, positive meaning of illness and quality of life.

This is the 2-year study. The design adopts the randomized controlled trial (RCT). The caregivers of patients with spouse caregivers of resectable metastatic colorectal cancer will be randomly assigned into two groups: one group receiving usual care, another group receiving the caregiver psychoeducational consultation program (CPCP). The usual care includes providing education materials only. Measurement time-points include pre intervention, post intervention, & then 1, and 3 months after the end of intervention for the maintenance effect.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Spouse caregivers of patients with resectable colorectal cancer,
  • Those who are willing to participate in the research,
  • Aged above 18.

Exclusion Criteria:

  • Who refuses to participate in this study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01001884

Contacts
Contact: Fei Hsiao, PhD +886-2-23123456 ext 88432 hsiaofei@ntu.edu.tw

Locations
Taiwan
Fei-Hsiu Hsiao Recruiting
Taipei, Taiwan, 10051
Contact: Fei Hsiao, PhD     +886-2-23123456 ext 88432     hsiaofei@ntu.edu.tw    
Principal Investigator: Fei Hsiao, PhD            
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Fei Hsiao, PhD Department of Nursing, College of Medicine, National Taiwan University
  More Information

No publications provided

Responsible Party: Fei-Hsiu Hsiao, Department of Nursing, College of Medicine, National Taiwan University
ClinicalTrials.gov Identifier: NCT01001884     History of Changes
Other Study ID Numbers: 200902029R
Study First Received: October 21, 2009
Last Updated: August 12, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
caregiver, psychoeducational, colon

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013