The Efficacy of the Caregiver Psychoeducational Consultation Program
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ClinicalTrials.gov Identifier: NCT01001884 |
Recruitment Status
: Unknown
Verified June 2010 by National Taiwan University Hospital.
Recruitment status was: Recruiting
First Posted
: October 27, 2009
Last Update Posted
: August 16, 2010
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depression Sleep | Other: caregiver psychoeducational consultation program (CPCP) | Phase 2 Phase 3 |
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 (Clinical Trial) |
Estimated Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Supportive Care |
Official Title: | The Efficacy of the Caregiver Psychoeducational Consultation Program in Spouse Caregivers of Resectable Colorectal Cancer |
Study Start Date : | February 2009 |
Estimated Primary Completion Date : | December 2010 |
Estimated Study Completion Date : | December 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: counseling
caregiver psychoeducational consultation program (CPCP)
|
Other: caregiver psychoeducational consultation program (CPCP)
6-session caregiver psychoeducational consultation program (CPCP)
Other Name: consultation
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- 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 ]
- Caregiver reaction assessment [ Time Frame: 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 ]
- Moss sleeping scale [ Time Frame: 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 ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01001884
Contact: Fei Hsiao, PhD | +886-2-23123456 ext 88432 | hsiaofei@ntu.edu.tw |
Taiwan | |
Fei-Hsiu Hsiao | Recruiting |
Taipei, Taiwan, 10051 | |
Contact: Fei Hsiao, PhD +886-2-23123456 ext 88432 hsiaofei@ntu.edu.tw | |
Principal Investigator: Fei Hsiao, PhD |
Principal Investigator: | Fei Hsiao, PhD | Department of Nursing, College of Medicine, National Taiwan University |
Responsible Party: | Fei-Hsiu Hsiao, Department of Nursing, College of Medicine, National Taiwan University |
ClinicalTrials.gov Identifier: | NCT01001884 History of Changes |
Other Study ID Numbers: |
200902029R |
First Posted: | October 27, 2009 Key Record Dates |
Last Update Posted: | August 16, 2010 |
Last Verified: | June 2010 |
Keywords provided by National Taiwan University Hospital:
caregiver, psychoeducational, colon |