Hospital Based Group Intervention for Breast Cancer Patients.

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00289432
• Other study ID #: INCAM
• Status: Completed
• Phase: N/A
• First received: February 8, 2006
• Last updated: April 29, 2015
• Start date: April 2006
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: December 2014
• Est. primary completion date: February 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 74 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Anxiety
• Breast Cancer
• Breast Neoplasms
• Coping
• Depression
• Quality of Life

Intervention

Behavioral:
• Psychoeducative
The experimental group consists of five weekly 2-hours sessions, focusing on coping with diagnosis and treatment

Other:
• Support group
Standard Hospital follow-up support group

Locations

Country	Name	City	State
Norway	Ullevaal University Hospital	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
Ullevaal University Hospital	The Royal Norwegian Ministry of Health

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scores on Health-related quality of life		2, 6 12 months and at 3 and 5 years	No