Clinical trial NCT01001884: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Depression
Sleep
Keywords: caregiver, psychoeducational, colon
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2009-10-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Short-form 12 health-related quality of life questionnaire
timeFrame: pre intervention, post intervention, 1, and 3,months after the end of the interventions
Secondary outcomes:
measure: Caregiver reaction assessment
timeFrame: pre intervention, post intervention, 1, and 3,months after the end of the interventions
measure: Experiences in close relationships scale
timeFrame: pre intervention, post intervention, 1, and 3,months after the end of the interventions
measure: Moss sleeping scale
timeFrame: pre intervention, post intervention, 1, and 3,months after the end of the interventions
measure: BDI-II depression scale
timeFrame: pre intervention, post intervention, 1, and 3,months after the end of the interventions
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Fei-Hsiu Hsiao
Study officials:
affiliation: Department of Nursing, College of Medicine, National Taiwan University
name: Fei Hsiao, PhD
role: PRINCIPAL_INVESTIGATOR
References: