The Efficacy of the Caregiver Psychoeducational Consultation Program
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 depression
Started Feb 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 21, 2009
CompletedFirst Posted
Study publicly available on registry
October 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedAugust 16, 2010
June 1, 2010
1.8 years
October 21, 2009
August 12, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Short-form 12 health-related quality of life questionnaire
pre intervention, post intervention, 1, and 3,months after the end of the interventions
Secondary Outcomes (4)
Caregiver reaction assessment
pre intervention, post intervention, 1, and 3,months after the end of the interventions
Experiences in close relationships scale
pre intervention, post intervention, 1, and 3,months after the end of the interventions
Moss sleeping scale
pre intervention, post intervention, 1, and 3,months after the end of the interventions
BDI-II depression scale
pre intervention, post intervention, 1, and 3,months after the end of the interventions
Study Arms (1)
counseling
EXPERIMENTALcaregiver psychoeducational consultation program (CPCP)
Interventions
6-session caregiver psychoeducational consultation program (CPCP)
Eligibility Criteria
You may qualify if:
- Spouse caregivers of patients with resectable colorectal cancer,
- Those who are willing to participate in the research,
- Aged above 18.
You may not qualify if:
- Who refuses to participate in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fei-Hsiu Hsiao
Taipei, 10051, Taiwan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fei Hsiao, PhD
Department of Nursing, College of Medicine, National Taiwan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 21, 2009
First Posted
October 27, 2009
Study Start
February 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2010
Last Updated
August 16, 2010
Record last verified: 2010-06