Know Cancer

forgot password

Effects of Group Intervention on Anxiety, Depression and Quality of Life Among Women Operated for Breast Cancer. A Randomized, Prospective Study.

18 Years
74 Years
Open (Enrolling)
Breast Cancer, Anxiety, Depression, Function Impairment, Immune Mechanism

Thank you

Trial Information

Effects of Group Intervention on Anxiety, Depression and Quality of Life Among Women Operated for Breast Cancer. A Randomized, Prospective Study.

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

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.

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


Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Outcome Measure:

Scores on Health-related quality of life

Outcome Time Frame:

2, 6 12 months and at 3 and 5 years

Safety Issue:


Principal Investigator

Inger Schou Bredal, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ullevaal University Hospital


Norway:National Committee for Medical and Health Research Ethics

Study ID:




Start Date:

April 2006

Completion Date:

February 2013

Related Keywords:

  • Breast Cancer
  • Anxiety
  • Depression
  • Function Impairment
  • Immune Mechanism
  • Anxiety Disorders
  • Breast Neoplasms
  • Depression
  • Depressive Disorder