Health and Coping Prior to Ovarian Cancer Surgery

NCT01213771 | Completed

• 1 other identifier: LS2008
• Study Type: interventional
• Target: 279
• Locations: 1 country
• Sites: 1

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.

Conditions

Health and Coping Undergoing Ovarian Cancer Surgery.; Cancer Rehabilitation

Keywords

Preoperative; Intervention; Support; Care

Outcome Measures

Primary Outcomes (1)

• SF 36

  The peri-operative period

  The day before surgery and 8 weeks after surgery

Study Arms (1)

Preoperative care 2009

NO INTERVENTION

Patients are receiving the usual care

Procedure: Preoperative preparation 2010

Interventions

Preoperative preparation 2010 PROCEDURE

Preoperative optimisation Supportive care LEAN in patient pathways

Also known as: Preoperative care

Preoperative care 2009

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women undergoing surgery on the suspicion of an ovarian malignancy

You may not qualify if:

• Mental disease, not being able to understand Danish,

Sponsors & Collaborators

• University of Aarhus: lead
• University of Southern Denmark: collaborator
• Aarhus University Hospital: collaborator
• Danish Cancer Society: collaborator

Study Sites (1)

Aarhus University Hospital, Skejby

Aarhus, 8200, Denmark

Location

MeSH Terms

Interventions

Preoperative Care

Intervention Hierarchy (Ancestors)

Perioperative Care; Patient Care; Therapeutics; Surgical Procedures, Operative; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Lise Hounsgaard, ass. prof.

  University of Southern Denmark

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 4, 2010
• Study Start: September 1, 2008
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 16, 2011

Record last verified: 2011-06

Locations

DK (1)