Hospital Based Group Intervention for Breast Cancer Patients.
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer Anxiety Depression Function Impairment Immune Mechanism |
Behavioral: Psychoeducative Other: Support group |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | Effects of Group Intervention on Anxiety, Depression and Quality of Life Among Women Operated for Breast Cancer. A Randomized, Prospective Study. |
- Scores on Health-related quality of life [ Time Frame: 2, 6 12 months and at 3 and 5 years ] [ Designated as safety issue: No ]
| Enrollment: | 450 |
| Study Start Date: | April 2006 |
| Estimated Study Completion Date: | February 2013 |
| Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Behavioral (Psychoeducative)
|
Behavioral: Psychoeducative
The experimental group consists of five weekly 2-hours sessions, focusing on coping with diagnosis and treatment
Other Name: Intervention group
|
|
Active Comparator: 2
The Hospitals standard support group
|
Other: Support group
Standard Hospital follow-up support group
Other Name: Standard group
|
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 responses,but 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 surgery,2,6,12 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.
Eligibility| Ages Eligible for Study: | 18 Years to 74 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Verified breast cancer diagnosis Age 18 years or more but under 75 years -
Exclusion Criteria:
Diagnoses of metastatic breast cancer Do not read or write Norwegian Diagnoses of mental retardation, severe or untreated psychopathology, dementia Diagnoses of any immunologic condition or disease
-
Contacts and Locations| Norway | |
| Ullevaal University Hospital | |
| Oslo, Norway, 0407 | |
| Principal Investigator: | Inger Schou Bredal, PhD | Ullevaal University Hospital |
More Information
No publications provided
| Responsible Party: | Inger Schou Bredal, Ullevaal university Hospital |
| ClinicalTrials.gov Identifier: | NCT00289432 History of Changes |
| Other Study ID Numbers: | INCAM |
| Study First Received: | February 8, 2006 |
| Last Updated: | July 5, 2011 |
| Health Authority: | Norway:National Committee for Medical and Health Research Ethics |
Additional relevant MeSH terms:
|
Anxiety Disorders Breast Neoplasms Depression Depressive Disorder Mental Disorders Neoplasms by Site |
Neoplasms Breast Diseases Skin Diseases Behavioral Symptoms Mood Disorders |
ClinicalTrials.gov processed this record on May 16, 2013