Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00289432
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2006-02-08
Brief Title:
Hospital Based Group Intervention for Breast Cancer Patients
Sponsor:
Ullevaal University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Effects of Group Intervention on Anxiety Depression and Quality of Life Among Women Operated for Breast Cancer A Randomized Prospective Study
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
INCAM-study is a multicenter prospective randomized controlled trial The aim of the study is to test the effectiveness of psychoeducative intervention when offered in hospital setting as a component of routine breast cancer care The hypotheses are - that breast cancer patients participating in psychoeducative interventions focusing on coping will experience better health-related quality of life than those who participate in the hospital standardised psychoeducative intervention - that coping styles are associated with the immune system
Detailed Description:
Women operated for breast cancer often experience psychosocial problems for several years Although meta-analyses have clearly demonstrated that the efficacy of psychosocial support groups little is known about the effectiveness of this intervention when offered in the hospital setting as a component of routine breast cancer care
A few studies have found that psychological intervention reduce emotional distress and enhance immune responsesbut if there is an association between coping styles and immune system is not clear
440 breast cancer patients at two Hospital will be randomized into the study Both Hospital have standardised psychoeducative interventions as a component of routine breast cancer care Both Hospital will have two groups the standardised groups and the experimental groups Participants will answer the same standardised questionnaires before surgery2612 months and 3 and 5 years after the interventions Blood sample will be drawn at all assessments The questionnaires are the Hospital Anxiety and Depression Scale the Mini-mental Adjustment to Cancer Scale the EORTC QLQ-BR32 the Life Orientation Test-Revised
All groups are facilitated by two nurse specialists and follow a structured program The standardised groups consists of three weekly 2-hours sessions and the experimental groups will consists of six weekly 2-hours session The intervention protocol has been approved by the Norwegian Committee for medical research Ethics
Knowledge from this study will be used to develop a manual for hospital based group interventions for breast cancer patients
A few studies have found that psychological intervention reduce emotional distress and enhance immune responsesbut if there is an association between coping styles and immune system is not clear
440 breast cancer patients at two Hospital will be randomized into the study Both Hospital have standardised psychoeducative interventions as a component of routine breast cancer care Both Hospital will have two groups the standardised groups and the experimental groups Participants will answer the same standardised questionnaires before surgery2612 months and 3 and 5 years after the interventions Blood sample will be drawn at all assessments The questionnaires are the Hospital Anxiety and Depression Scale the Mini-mental Adjustment to Cancer Scale the EORTC QLQ-BR32 the Life Orientation Test-Revised
All groups are facilitated by two nurse specialists and follow a structured program The standardised groups consists of three weekly 2-hours sessions and the experimental groups will consists of six weekly 2-hours session The intervention protocol has been approved by the Norwegian Committee for medical research Ethics
Knowledge from this study will be used to develop a manual for hospital based group interventions for breast cancer patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None