The Efficacy of the Caregiver Psychoeducational Consultation Program

Depression Clinical Trial

Official title:

The Efficacy of the Caregiver Psychoeducational Consultation Program in Spouse Caregivers of Resectable Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01001884
• Other study ID #: 200902029R
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: October 21, 2009
• Last updated: August 12, 2010
• Start date: February 2009
• Est. completion date: December 2010

Study information

• Verified date: June 2010
• Source: National Taiwan University Hospital
• Contact: Fei Hsiao, PhD
• Phone: +886-2-23123456
• Email: hsiaofei[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Depression
• Sleep

Intervention

Other:
• caregiver psychoeducational consultation program (CPCP)
6-session caregiver psychoeducational consultation program (CPCP)

Locations

Country	Name	City	State
Taiwan	Fei-Hsiu Hsiao	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Short-form 12 health-related quality of life questionnaire		pre intervention, post intervention, 1, and 3,months after the end of the interventions	Yes
Secondary	Caregiver reaction assessment		pre intervention, post intervention, 1, and 3,months after the end of the interventions	Yes
Secondary	Experiences in close relationships scale		pre intervention, post intervention, 1, and 3,months after the end of the interventions	Yes
Secondary	Moss sleeping scale		pre intervention, post intervention, 1, and 3,months after the end of the interventions	Yes
Secondary	BDI-II depression scale		pre intervention, post intervention, 1, and 3,months after the end of the interventions	Yes