Quality of Life After Robotic Surgery for Endometrial Cancer

NCT04281043 | Completed

• 1 other identifier: QoL Robot
• Study Type: observational
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Quality of Life; Endometrial Cancer; Surgery--Complications; Gynecologic Cancer

Outcome Measures

Primary Outcomes (2)

• Quality of Life at 3 months

  Quality of Life at 3 months postoperatively compared to preoperatively The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. Allofthescalesandsingle-itemmeasuresrangeinscorefrom0to100. Ahighscalescore represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. The attached module EN24 has 3 functional scales and several symptom scales, which scores follows the same system.

  3 months

• Quality of Life at 12 months

  Quality of Life at 12 months postoperatively compared to preoperatively The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items. Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. Allofthescalesandsingle-itemmeasuresrangeinscorefrom0to100. Ahighscalescore represents a higher response level. Thus a high score for a functional scale represents a high / healthy level of functioning, a high score for the global health status / QoL represents a high QoL, but a high score for a symptom scale / item represents a high level of symptomatology / problems. The attached module EN24 has 3 functional scales and several symptom scales, which scores follows the same system.

  12 months

Secondary Outcomes (4)

• Anxiety scores

  3 months

• Anxiety scores

  12 months

• Depression scores

  3 months

• Depression scores

  12 months

Eligibility Criteria

• Age: 18 Months+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Hjalmar Svensson Foundation: collaborator
• Assar Gabrielsson Foundation: collaborator
• Göteborg Medical Society: collaborator

Study Sites (1)

1Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Gothenburg, Sweden

Gothenburg, 41345, Sweden

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: February 18, 2020
• First Posted: February 21, 2020
• Study Start: June 15, 2019
• Primary Completion: June 15, 2020
• Study Completion: September 15, 2021
• Last Updated: April 12, 2023

Record last verified: 2023-04

Locations

SE (1)