Quality of LifeQoLNCT04281043
Quality of Life After Robotic Surgery for Endometrial Cancer
An observational study of Quality of Life and Endometrial Cancer, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 months and older, women only
- Conditions the study is for
- Quality of Life, Endometrial Cancer, Surgery--Complications
- How many people
- 64 participants
- Where
- 1 siteSweden
- Study dates
- 15 Jun 2019to 15 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 months and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Clinical or radiological cancer outside the uterus
- preoperative radio / chemotherapy.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
1Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Gothenburg, Sweden
Gothenburg, 41345
About this study
Official title: Quality of Life After Robotic Surgery as Primary Treatment for Endometrial Cancer
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.
Read the 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.
- Medical subject headings
- Endometrial Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 12 months
Secondary outcomes (4)
Anxiety scores
Scores on GAD7 3 months postoperatively compared to preoperatively Scores 0-21, were a higher scores is associated with more symptoms.
Measured: 3 months
Anxiety scores
Scores on GAD7 12 months postoperatively compared to preoperatively
Measured: 12 months
Depression scores
Scores on PHQ9 3 months postoperatively compared to preoperatively. Scores 0-27 were a high score is associated with more symptoms.
Measured: 3 months
Depression scores
Scores on PHQ9 12 months postoperatively compared to preoperatively. Scores 0-27 were a high score is associated with more symptoms.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start15 Jun 2019
- Primary completion15 Jun 2020
- Study completion15 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hjalmar Svensson Foundation, Assar Gabrielsson Foundation, Göteborg Medical Society
- Responsible party
- Principal investigator, Anna Lindfors, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04281043
- Sponsor's protocol ID
- QoL Robot
- Acronym
- QoL
- Status last verified
- Apr 2023
- First submitted
- 18 Feb 2020
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life After Robotic Surgery as Primary Treatment for Endometrial Cancer
- ClinicalTrials.gov ID
- NCT04281043
- Acronym / sponsor ID
- QoL / QoL Robot
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- Hjalmar Svensson Foundation, Assar Gabrielsson Foundation, Göteborg Medical Society
- Study start
- 15 Jun 2019 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 15 Sep 2021 (actual)
- First posted
- 21 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 months and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Clinical or radiological cancer outside the uterus
- preoperative radio / chemotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of Life at 3 months
Time frame: 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.
Quality of Life at 12 months
Time frame: 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.
4 secondary outcomes
Anxiety scores
Time frame: 3 months
Anxiety scores
Time frame: 12 months
Depression scores
Time frame: 3 months
Depression scores
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Endometrial Cancer, run by Sahlgrenska University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Life at 3 months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.