Clinical trial NCT04281043: Quality of Life After Robotic Surgery for Endometrial Cancer
Official title: Quality of Life After Robotic Surgery as Primary Treatment for Endometrial Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Endometrial Cancer
Surgery--Complications
Gynecologic Cancer
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
Collaborators: name: Hjalmar Svensson Foundation
name: Assar Gabrielsson Foundation
name: Göteborg Medical Society
First posted: 2020-02-21
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients planned for primary surgery with robotic technique for endometrial cancer at Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Gothenburg, Sweden will be asked to participate.

Brief summary: The purpose of this study is to investigate how robotic assisted laparoscopic surgery affects the quality of life of women who are treated with primary surgery for endometrial cancer. So far, very little has been published and basically no long-term follow-up.

Included patients respond to questionnaires preoperatively, 2 weeks after surgery and 3 months and 12 months after surgery.

Each patient thus answers the questionnaires (the same) on four occasions. The questionnaires used are validated and used extensively internationally. The first survey has two parts, QLQ30 and the module for endometrial cancer EN24. In addition the study includes use PHQ -9 and GAD 7.

Detailed 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 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.

Eligibility criteria: Inclusion Criteria:

* Woman over 18 years of age
* scheduled for primary surgery for histologically verified endometrial cancer (regardless of histological type or degree),
* tumor clinically restricted to the uterus (presumptive FIGO stage I or II),
* speaks and reads Swedish,
* capable of completing the questionnaire independently.

Exclusion Criteria:

* Clinical or radiological cancer outside the uterus
* preoperative radio / chemotherapy.

Primary outcomes:
measure: Quality of Life at 3 months
timeFrame: 3 months
measure: Quality of Life at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Anxiety scores
timeFrame: 3 months
measure: Anxiety scores
timeFrame: 12 months
measure: Depression scores
timeFrame: 3 months
measure: Depression scores
timeFrame: 12 months
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: 1Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Gothenburg, Sweden
Study officials:
References: