Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
50

Summary

Conditions
  • Endometrial Cancer
  • Gynecologic Cancer
  • Quality of Life
  • Surgery- Complications
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Only males

Description

Objective: In a pilot study to prospectively analyze the quality of life using QLQ-C30, EN-24, PHQ-9 and GAD7 in women undergoing primary surgery with robotic assisted laparoscopy for corpus cancer before and up to one year after surgery. The study aims to describe how, to what extent and when in re...

Objective: In a pilot study to prospectively analyze the quality of life using QLQ-C30, EN-24, PHQ-9 and GAD7 in women undergoing primary surgery with robotic assisted laparoscopy for corpus cancer before and up to one year after surgery. The study aims to describe how, to what extent and when in relation to primary surgery women's quality of life is affected after the diagnosis of endometrial cancer. The long-term goal of the work is to be able to deploy any resources if needs exist, and in this case at a time when they are most useful, to promote the quality of life of the affected women. Question: How and when is the quality of life of women undergoing surgery for endometrial cancer affected? Is there any particular area / domain that is affected more than others and is this impact persistent over time? Method: The international and validated survey, QLQ-C30 with the addition of EN24, developed by the European Organization for Research and Treatment of Cancer (EORTC) for quality of life measurement specifically for endometrial cancer in addition to PHQ-9 and GAD7 to evaluate depression and anxiety symtoms, is planned to be used just before primary surgery, 1-2 weeks, 3 months and 1 years postoperatively. Referens to the QLQ30 questionnaire below. Patients are included at Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Gothenburg, Sweden for one year. All patients included should give their oral and written consent. All data will be registered coded and analyzed without personal identification number according to the scoring manual from EORTC. Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JCJM, Kaasa S, Klee MC, Osoba D, Razavi D, Rofe PB, Schraub S, Sneeuw KCA, Sullivan M, Takeda F. The European Organisation for Research and Treatment of Cancer QLQ-C30: A quality-of-life instrument for use in international clinical trials in oncology. Journal of the National Cancer Institute 1993; 85: 365-376.

Tracking Information

NCT #
NCT04281043
Collaborators
  • Hjalmar Svensson Foundation
  • Assar Gabrielsson Foundation
  • Göteborg Medical Society
Investigators
Not Provided