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Health and Coping Prior to Ovarian Cancer Surgery

Primary Purpose

Health and Coping Undergoing Ovarian Cancer Surgery., Cancer Rehabilitation

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Preoperative preparation 2010
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Health and Coping Undergoing Ovarian Cancer Surgery. focused on measuring Preoperative, Intervention, Support, Care

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Women undergoing surgery on the suspicion of an ovarian malignancy

Exclusion Criteria:

  • Mental disease, not being able to understand Danish,

Sites / Locations

  • Aarhus University Hospital, Skejby

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Preoperative care 2009

Arm Description

Patients are receiving the usual care

Outcomes

Primary Outcome Measures

SF 36
The peri-operative period

Secondary Outcome Measures

Full Information

First Posted
October 1, 2010
Last Updated
June 15, 2011
Sponsor
University of Aarhus
Collaborators
University of Southern Denmark, Aarhus University Hospital, Danish Cancer Society
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1. Study Identification

Unique Protocol Identification Number
NCT01213771
Brief Title
Health and Coping Prior to Ovarian Cancer Surgery
Official Title
Health and Coping Prior to Ovarian Cancer Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Aarhus
Collaborators
University of Southern Denmark, Aarhus University Hospital, Danish Cancer Society

4. Oversight

Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health and Coping Undergoing Ovarian Cancer Surgery., Cancer Rehabilitation
Keywords
Preoperative, Intervention, Support, Care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
279 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preoperative care 2009
Arm Type
No Intervention
Arm Description
Patients are receiving the usual care
Intervention Type
Procedure
Intervention Name(s)
Preoperative preparation 2010
Other Intervention Name(s)
Preoperative care
Intervention Description
Preoperative optimisation Supportive care LEAN in patient pathways
Primary Outcome Measure Information:
Title
SF 36
Description
The peri-operative period
Time Frame
The day before surgery and 8 weeks after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women undergoing surgery on the suspicion of an ovarian malignancy Exclusion Criteria: Mental disease, not being able to understand Danish,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lise Hounsgaard, ass. prof.
Organizational Affiliation
University of Southern Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Aarhus University Hospital, Skejby
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark

12. IPD Sharing Statement

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Health and Coping Prior to Ovarian Cancer Surgery

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