Fra kontrol til opfølgning: Udarbejdelse, implementering og evaluering af et individualiseret opfølgningstilbud for kvinder med gynækologisk kræft- et randomiseret, kontrolleret studie
This NEw MOdel of follow-up study (the NEMO study) aim to develop and evaluate a nurse-led, individualized follow-up program for women with gynecological cancer. The program has a patient-centered approach that addresses the patient's impairments and need for professional help. It seeks to support the patient's self-efficacy to self-manage life after cancer hence supporting a shared decision-making between the patient and the health care system.
The 2015 release of a new ‘Follow-up Program for Gynaecological Cancers' by the Danish Health Authority marked a break with traditional follow-up. The conclusion was that regular follow-up visits of patients with cervical or endometrial cancer, do not improve survival rates or the detection of recurrences and may consume unnecessary resources. As a consequence, a need based follow-up program was proposed where patients' follow-up course are planned individually and continuously adjusted. Patients' needs for reassurance and continuity in the follow-up course must be addressed and patients' selv-care ability and involvement in the follow-up process must be enhanced.
The new program has now been implemented in various forms in most national gynaecological centres, and to our knowledge, all with a doctors led approach. Little is known about the possible benefits and harms of patients of the need based model and despite the desire for common professional attitudes to this transformation both nationally and within the Danish regions, there is still neither consistency nor sufficient knowledge about the optimal organisational model. This may cause insecurity among gynaecological cancer patients as they are offered different survivorship plans depending on treatment localisation.
The optimal follow up model may integrate the elements proposed in the new follow-up program, but should also embrace patient's fears and psychosocial problems and be carried out in a setting supporting patient's self-care ability without compromising survival and detection of recurrence. In the present study an innovative model is tested where specialised nurses handle the follow-up of endometrial and cervical cancer patients in the intervention group. The model is based on telephone consultations and developed to ensure identification of alarm symptoms and addressing patient's fear of recurrence and potential unmet needs. The patient is actively involved in the process to promote her ability to self- manage in life after cancer.
The nurse led model is compared to a doctor led model (control group) with outpatient consultations based on individualised need assessment, but with no specific focus on promoting self-care or on patient's fear of recurrence or psychosocial problems or needs.
Description of the cohort
Women operated for endometrial or cervical cancer at the Department of Gynaecology at Odense University Hospital, are eligible. Participants are randomized to doctor led (control) or nurse led (intervention) follow-up if declared disease free 4 months postoperatively.
Data and biological material
The effect of the intervention is measured by PROMs with the primary outcome being fear of cancer recurrence and psychological distress, self-care ability, patient involvement, satisfaction with care and quality of life as secondary outcomes. Data is obtained from patient questionnaires and register data. Questionnaires are administered to all patients at baseline, i.e. at the outpatient contact 4 months postoperatively, and 12, 18 and 36 months postoperatively.
Fear of cancer recurrence is measured by the validated 42-item Fear of Cancer Recurrence Inventory (FCRI) 12 months postoperatively.
Secondary outcomes include FCRI at 24 and 36 months respectively, the degree of psychological distress (Profile Of Mood States scale, POMS), Quality Of Life (EORTC QLQ C30) plus disease-specific late effects for cervical cancer (QLQ-CX24) and for endometrial cancer (QLQ-EN24). Further, self-care ability (General Self- Efficacy scale, GSE) and health status (EQ5D) after 12, 24 and 36 months will be assessed.
These validated questionnaires are supplemented by ad hoc questions on patient satisfaction with and involvement in the follow-up process as well as their experience of continuity during the process. The baseline questionnaire will include questions on socio-demographic factors such as education, employment status, income, cohabitant status, comorbidity, height/weight (BMI) and smoking status.
Via extracts from the National Patient Register and the Danish Pathology Register, information on disease-free survival (DFS) and incidence of disease recurrence (IDR) are obtained for all patients.
Collaborating researchers and departments
Department of Gynaecology and Obstetrics, Odense University Hospital
- Resident, Stinne Holm Bergholdt
- Senior consultant, Pernille Tine Jensen
National Research Center of Cancer Rehabilitation Research and Research Unit for General Practice, University of Southern Denmark
- Associate Professor, Dorte Gilså Hansen
Department of Gynaecological Oncology, Karolinske University Hospital