Quality of Life Clinical Trial
— QoLOfficial title:
Quality of Life After Robotic Surgery as Primary Treatment for Endometrial Cancer
NCT number | NCT04281043 |
Other study ID # | QoL Robot |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 15, 2019 |
Est. completion date | September 15, 2021 |
Verified date | April 2023 |
Source | Sahlgrenska University Hospital, Sweden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 64 |
Est. completion date | September 15, 2021 |
Est. primary completion date | June 15, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Months and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Sweden | 1Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Gothenburg, Sweden | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Sahlgrenska University Hospital, Sweden | Assar Gabrielsson Foundation, Göteborg Medical Society, Hjalmar Svensson Foundation |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Anxiety scores | Scores on GAD7 3 months postoperatively compared to preoperatively Scores 0-21, were a higher scores is associated with more symptoms. | 3 months | |
Secondary | Anxiety scores | Scores on GAD7 12 months postoperatively compared to preoperatively | 12 months | |
Secondary | Depression scores | Scores on PHQ9 3 months postoperatively compared to preoperatively. Scores 0-27 were a high score is associated with more symptoms. | 3 months | |
Secondary | Depression scores | Scores on PHQ9 12 months postoperatively compared to preoperatively. Scores 0-27 were a high score is associated with more symptoms. | 12 months |
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