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The Efficacy of the Caregiver Psychoeducational Consultation Program

Primary Purpose

Depression, Sleep

Status
Unknown status
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
caregiver psychoeducational consultation program (CPCP)
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring caregiver, psychoeducational, colon

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fei-Hsiu HsiaoRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

counseling

Arm Description

caregiver psychoeducational consultation program (CPCP)

Outcomes

Primary Outcome Measures

Short-form 12 health-related quality of life questionnaire

Secondary Outcome Measures

Caregiver reaction assessment
Experiences in close relationships scale
Moss sleeping scale
BDI-II depression scale

Full Information

First Posted
October 21, 2009
Last Updated
August 12, 2010
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01001884
Brief Title
The Efficacy of the Caregiver Psychoeducational Consultation Program
Official Title
The Efficacy of the Caregiver Psychoeducational Consultation Program in Spouse Caregivers of Resectable Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2010
Overall Recruitment Status
Unknown status
Study Start Date
February 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Sleep
Keywords
caregiver, psychoeducational, colon

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
counseling
Arm Type
Experimental
Arm Description
caregiver psychoeducational consultation program (CPCP)
Intervention Type
Other
Intervention Name(s)
caregiver psychoeducational consultation program (CPCP)
Other Intervention Name(s)
consultation
Intervention Description
6-session caregiver psychoeducational consultation program (CPCP)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Caregiver reaction assessment
Time Frame
pre intervention, post intervention, 1, and 3,months after the end of the interventions
Title
Experiences in close relationships scale
Time Frame
pre intervention, post intervention, 1, and 3,months after the end of the interventions
Title
Moss sleeping scale
Time Frame
pre intervention, post intervention, 1, and 3,months after the end of the interventions
Title
BDI-II depression scale
Time Frame
pre intervention, post intervention, 1, and 3,months after the end of the interventions

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Hsiao, PhD
Phone
+886-2-23123456
Ext
88432
Email
hsiaofei@ntu.edu.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fei Hsiao, PhD
Organizational Affiliation
Department of Nursing, College of Medicine, National Taiwan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fei-Hsiu Hsiao
City
Taipei
ZIP/Postal Code
10051
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Hsiao, PhD
Phone
+886-2-23123456
Ext
88432
Email
hsiaofei@ntu.edu.tw
First Name & Middle Initial & Last Name & Degree
Fei Hsiao, PhD

12. IPD Sharing Statement

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The Efficacy of the Caregiver Psychoeducational Consultation Program

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