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Completed

NCT Number: NCT00289432

Hospital Based Group Intervention for Breast Cancer Patients.

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.

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Key information

Age range

18 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ullevaal University Hospital

Oslo, 0407, Norway

About this 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 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

Psychoeducative

Behavioral

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

Other names: Intervention group

Support Group

Other

Standard Hospital follow-up support group

Other names: Standard group

Primary outcomes

  1. Scores on Health-related quality of life

    Time frame: 2, 6 12 months and at 3 and 5 years

Sponsors and collaborators

Lead sponsor

Ullevaal University Hospital

Other

Collaborators

  • The Royal Norwegian Ministry of Health

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2014
First posted
Feb 9, 2006
Registry last updated
Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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