Hospital Based Group Intervention for Breast Cancer Patients.
Effects of Group Intervention on Anxiety, Depression and Quality of Life Among Women Operated for Breast Cancer. A Randomized, Prospective Study.
1 other identifier
interventional
450
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Apr 2006
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2006
CompletedFirst Posted
Study publicly available on registry
February 9, 2006
CompletedStudy Start
First participant enrolled
April 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedApril 30, 2015
April 1, 2015
2.8 years
February 8, 2006
April 29, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Scores on Health-related quality of life
2, 6 12 months and at 3 and 5 years
Study Arms (2)
1
EXPERIMENTALBehavioral: Psychoeducative intervention
2
ACTIVE COMPARATORThe Hospitals standard follow-up support group
Interventions
The experimental group consists of five weekly 2-hours sessions, focusing on coping with diagnosis and treatment
Eligibility Criteria
You may qualify if:
- Verified breast cancer diagnosis Age 18 years or more but under 75 years -
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ullevaal University Hospital
Oslo, Oslo County, 0407, Norway
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Inger Schou Bredal, PhD
Ullevaal University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 8, 2006
First Posted
February 9, 2006
Study Start
April 1, 2006
Primary Completion
February 1, 2009
Study Completion
December 1, 2014
Last Updated
April 30, 2015
Record last verified: 2015-04