Trial Information
Person-centred Support for Women in the Follow-up Period After Surgical Treatment for Gynaecological Cancer - a Randomised Controlled Trial
Inclusion Criteria:
- Women only surgically treated for cervix, ovarian (including borderline tumors),
endometrial or vulva cancer, who attend follow up at the Gynaecological Department at
The University Hospital Rigshospitalet in Copenhagen.
- The women should read, write and understand the danish language.
Exclusion criteria:
- Known recurrence.
- Participation in the preliminary pilotstudy.
- Health related problems both physical or psychological, that prevent participation.
For example cognitive impairment, or patients with psychiatric diseases that is
estimated to require nurses with competences within the psychiatric speciality.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Primary Outcome: Quality of life measured by the scale Quality of life- Cancer Survivors (QOL-CS)
Outcome Description:
+/- one week for practical reasons
Outcome Time Frame:
9 months after randomisation
Safety Issue:
No
Authority:
Denmark: The Capital Region of Denmark
Study ID:
H-4-2012-FSP(94)
NCT ID:
NCT01784406
Start Date:
January 2013
Completion Date:
February 2015
Related Keywords:
- Malignant Female Reproductive System Neoplasm
- Follow-up
- Supportive Care
- Psychosocial Circumstances
- Survivorship
- Self-management intervention
- Psychosocial care
- Autonomy-supportive
- Gynaecological cancer survivors
- Guided self-Determination
- Neoplasms
- Genital Neoplasms, Female