Cancer Rehabilitation Clinical Trial
Official title:
Health and Coping Prior to Ovarian Cancer Surgery
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.
| Status | Completed |
| Enrollment | 279 |
| Est. completion date | June 2011 |
| Est. primary completion date | June 2011 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - Women undergoing surgery on the suspicion of an ovarian malignancy Exclusion Criteria: - Mental disease, not being able to understand Danish, |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Aarhus University Hospital, Skejby | Aarhus |
| Lead Sponsor | Collaborator |
|---|---|
| University of Aarhus | Aarhus University Hospital, Danish Cancer Society, University of Southern Denmark |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | SF 36 | The peri-operative period | The day before surgery and 8 weeks after surgery | Yes |
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