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Hospital Based Group Intervention for Breast Cancer Patients.

Sponsor
Ullevaal University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00289432
Collaborator
The Royal Norwegian Ministry of Health (Other)
450
Enrollment
1
Location
2
Arms
104
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Psychoeducative
  • Other: Support group
 N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
450 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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.
Study Start Date :
Apr 1, 2006
Actual Primary Completion Date :
Feb 1, 2009
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Intervention group

    		•
    Active Comparator: 2

    The Hospitals standard follow-up support group

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Scores on Health-related quality of life [2, 6 12 months and at 3 and 5 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 74 Years
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Inger Schou Bredal, Associate Professor, Oslo University Hospital
    ClinicalTrials.gov Identifier:
    NCT00289432
    Other Study ID Numbers:
    • INCAM
    First Posted:
    Feb 9, 2006
    Last Update Posted:
    Apr 30, 2015
    Last Verified:
    Apr 1, 2015
    Additional relevant MeSH terms:
    Breast Neoplasms
    Depression

    Study Results

    No Results Posted as of Apr 30, 2015