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The Efficacy of the Caregiver Psychoeducational Consultation Program

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ClinicalTrials.gov Identifier: NCT01001884
Recruitment Status : Unknown
Verified June 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : October 27, 2009
Last Update Posted : August 16, 2010
Sponsor:
Information provided by:
National Taiwan University Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:

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 or disease Intervention/treatment Phase
Depression Sleep Other: caregiver psychoeducational consultation program (CPCP) Phase 2 Phase 3

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.


Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Supportive Care
Official Title: The Efficacy of the Caregiver Psychoeducational Consultation Program in Spouse Caregivers of Resectable Colorectal Cancer
Study Start Date : February 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: counseling
caregiver psychoeducational consultation program (CPCP)
 Other: caregiver psychoeducational consultation program (CPCP)
6-session caregiver psychoeducational consultation program (CPCP)
Other Name: consultation


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Caregiver reaction assessment [ Time Frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions ]
  2. Experiences in close relationships scale [ Time Frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions ]
  3. Moss sleeping scale [ Time Frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions ]
  4. BDI-II depression scale [ Time Frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: August 16, 2010
Last Verified: June 2010

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