The Efficacy of the Caregiver Psychoeducational Consultation Program

August 12, 2010 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 10051
        • Recruiting
        • Fei-Hsiu Hsiao
        • Contact:
        • Principal Investigator:
          • Fei Hsiao, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: counseling
caregiver psychoeducational consultation program (CPCP)
Other: caregiver psychoeducational consultation program (CPCP)
6-session caregiver psychoeducational consultation program (CPCP)
Other Names:
  • consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
pre intervention, post intervention, 1, and 3,months after the end of the interventions

Secondary Outcome Measures

Outcome Measure
Time Frame
Caregiver reaction assessment
Time Frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions
pre intervention, post intervention, 1, and 3,months after the end of the interventions
Experiences in close relationships scale
Time Frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions
pre intervention, post intervention, 1, and 3,months after the end of the interventions
Moss sleeping scale
Time Frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions
pre intervention, post intervention, 1, and 3,months after the end of the interventions
BDI-II depression scale
Time Frame: pre intervention, post intervention, 1, and 3,months after the end of the interventions
pre intervention, post intervention, 1, and 3,months after the end of the interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Fei Hsiao, PhD, Department of Nursing, College of Medicine, National Taiwan University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2010

Study Completion (ANTICIPATED)

December 1, 2010

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

October 26, 2009

First Posted (ESTIMATE)

October 27, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

August 16, 2010

Last Update Submitted That Met QC Criteria

August 12, 2010

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200902029R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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