Health and Coping Prior to Ovarian Cancer Surgery

Sponsor

University of Aarhus (Other)

Overall Status

Completed

CT.gov ID

NCT01213771

Collaborator

University of Southern Denmark (Other), Aarhus University Hospital (Other), Danish Cancer Society (Other)

279

Enrollment

Location

Arm

Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

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 :

Sep 1, 2008

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

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 Names: Preoperative care

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 Names:

Preoperative care

Outcome Measures

Primary Outcome Measures

SF 36 [The day before surgery and 8 weeks after surgery]
The peri-operative period

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women undergoing surgery on the suspicion of an ovarian malignancy

Exclusion Criteria:

Mental disease, not being able to understand Danish,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Aarhus University Hospital, Skejby	Aarhus		Denmark	8200

Sponsors and Collaborators

University of Aarhus
University of Southern Denmark
Aarhus University Hospital
Danish Cancer Society

Investigators

Study Chair: Lise Hounsgaard, ass. prof., University of Southern Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT01213771

Other Study ID Numbers:

LS2008

First Posted:

Oct 4, 2010

Last Update Posted:

Jun 16, 2011

Last Verified:

Jun 1, 2011

Keywords provided by , ,

Additional relevant MeSH terms:

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Study Results

No Results Posted as of Jun 16, 2011