Viewing Study NCT01213771



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Study NCT ID: NCT01213771
Status: COMPLETED
Last Update Posted: 2011-06-16
First Post: 2010-10-01

Brief Title: Health and Coping Prior to Ovarian Cancer Surgery
Sponsor: University of Aarhus
Organization: University of Aarhus

Study Overview

Official Title: Health and Coping Prior to Ovarian Cancer Surgery
Status: COMPLETED
Status Verified Date: 2011-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Background Denmark has a record-high incidence of and mortality rate for ovarian cancer There are 600 new cases of ovarian cancer each year In 2008 the state issued a guarantee of early diagnosis and treatment of all cases of suspected cancer and surgical treatment has been centralised and standardised in fast track programmes However the investigators do not know how women with ovarian cancer experience the period prior to surgery and how they can optimally prepare for treatment and care

Aim The two principal aims of the study are to describe health and coping in Danish women surgically treated for ovarian cancer and to examine to what extent it is possible from both a patient and professional perspective to improve the health and everyday life of patients with ovarian cancer

Materials and methods The study is conducted within the scientific theoretical framework of hermeneutics involving the overall concepts of health promotion and rehabilitation The study will be carried out in 4 stages between September 2008 and September 2011 Stage 1 A health-related characterisation of Danish women with ovarian cancer through a registration process Stage 2 Qualitative research interviews with patients to gain knowledge about spontaneous preoperative coping strategies and resources

Stage 3 The preoperative preparation programme will be developed and clinically tested The effect of participation will be measured by self-assessed health and coping before and after surgery The study period runs from the time the decision is taken to operate until eight weeks after discharge The study takes place at the Department of Gynaecology at Aarhus University Hospital Skejby in Denmark which is a regional centre of surgical treatment of gynaecological cancer

Results The study provides insight into the preoperative coping strategies and general health of Danish women suffering from ovarian cancer The development and testing of the preoperative preparation programme contributes to knowledge about optimisation of preoperative preparation This might have a positive impact on the participants general health and level of functioning during their treatment Furthermore the project contributes to knowledge of the preoperative coping strategies and experiences of female cancer patients in general
Detailed Description: Supervisors Lise Hounsgaard Associate Professor PhD Research Unit of Nursing Institute of Clinical Research Faculty of Health Sciences University of Southern Denmark Lone Kjeld Petersen Consultant DMSc and Jan Blaakær Consultant DMScDepartment of Gynaecology and Obstetrics Y Aarhus University Hospital Skejby

Funding Faculty of Health Sciences University of Southern Denmark Department of Gynaecology and Obstetrics Y Aarhus University Hospital Skejby The Research Foundation of Health Science in Central Denmark Region The Research Foundation of Aarhus University Hospital Skejby The Hede Nielsen Foundation The Danish Cancer Society Psychosocial Research Committee Tha Danish Nurses organisation

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None