Health and Coping Prior to Ovarian Cancer Surgery

This study has been completed.
Sponsor:
Collaborators:
University of Southern Denmark
Aarhus University Hospital
Danish Cancer Society
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01213771
First received: October 1, 2010
Last updated: June 15, 2011
Last verified: June 2011
  Purpose

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 Intervention
Health and Coping Undergoing Ovarian Cancer Surgery.
Cancer Rehabilitation
Procedure: Preoperative preparation 2010

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Health and Coping Prior to Ovarian Cancer Surgery

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • SF 36 [ Time Frame: The day before surgery and 8 weeks after surgery ] [ Designated as safety issue: Yes ]
    The peri-operative period


Enrollment: 279
Study Start Date: September 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01213771

Locations
Denmark
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
  More Information

Additional Information:
No publications provided

Responsible Party: Lene Seibæk, Aarhus Univerity Hospital
ClinicalTrials.gov Identifier: NCT01213771     History of Changes
Other Study ID Numbers: LS2008
Study First Received: October 1, 2010
Last Updated: June 15, 2011
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
Preoperative
Intervention
Support
Care

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

ClinicalTrials.gov processed this record on July 22, 2014