Hospital Based Group Intervention for Breast Cancer Patients.

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Oslo University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
The Royal Norwegian Ministry of Health
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00289432
First received: February 8, 2006
Last updated: July 5, 2011
Last verified: July 2010
  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.

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00289432

Locations
Norway
Ullevaal University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
The Royal Norwegian Ministry of Health
Investigators
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 August 28, 2014