Health and Coping Prior to Ovarian Cancer Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01213771
Recruitment Status : Completed
First Posted : October 4, 2010
Last Update Posted : June 16, 2011
University of Southern Denmark
Aarhus University Hospital
Danish Cancer Society
Information provided by:
University of Aarhus

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.

Condition or disease Intervention/treatment Phase
Health and Coping Undergoing Ovarian Cancer Surgery. Cancer Rehabilitation Procedure: Preoperative preparation 2010 Not Applicable

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, DMSc.Department 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 279 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Health and Coping Prior to Ovarian Cancer Surgery
Study Start Date : September 2008
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
No Intervention: Preoperative care 2009
Patients are receiving the usual care
Procedure: Preoperative preparation 2010
Preoperative optimisation Supportive care LEAN in patient pathways
Other Name: Preoperative care

Primary Outcome Measures :
  1. SF 36 [ Time Frame: The day before surgery and 8 weeks after surgery ]
    The peri-operative period

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women undergoing surgery on the suspicion of an ovarian malignancy

Exclusion Criteria:

  • Mental disease, not being able to understand Danish,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01213771

Aarhus University Hospital, Skejby
Aarhus, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
University of Southern Denmark
Aarhus University Hospital
Danish Cancer Society
Study Chair: Lise Hounsgaard, ass. prof. University of Southern Denmark

Responsible Party: Lene Seibæk, Aarhus Univerity Hospital Identifier: NCT01213771     History of Changes
Other Study ID Numbers: LS2008
First Posted: October 4, 2010    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: June 2011

Keywords provided by University of Aarhus:

Additional relevant MeSH terms:
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders