Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Hospital Based Group Intervention for Breast Cancer Patients.

This study has been completed.
The Royal Norwegian Ministry of Health
Information provided by (Responsible Party):
Inger Schou Bredal, Oslo University Hospital Identifier:
First received: February 8, 2006
Last updated: April 29, 2015
Last verified: April 2015
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
Quality of Life
Behavioral: Psychoeducative
Other: Support group

Study Type: Interventional
Study Design: Allocation: Randomized
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 ]

Enrollment: 450
Study Start Date: April 2006
Study Completion Date: December 2014
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Behavioral: Psychoeducative intervention
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 follow-up 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.


Ages Eligible for Study:   18 Years to 74 Years   (Adult, Senior)
Sexes 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
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 identifier: NCT00289432

Ullevaal University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
The Royal Norwegian Ministry of Health
Principal Investigator: Inger Schou Bredal, PhD Ullevaal University Hospital
  More Information

Responsible Party: Inger Schou Bredal, Associate Professor, Oslo University Hospital Identifier: NCT00289432     History of Changes
Other Study ID Numbers: INCAM
Study First Received: February 8, 2006
Last Updated: April 29, 2015

Additional relevant MeSH terms:
Breast Neoplasms
Depressive Disorder
Neoplasms by Site
Breast Diseases
Skin Diseases
Behavioral Symptoms
Mood Disorders
Mental Disorders processed this record on April 28, 2017