Endometrial CancerNCT03813719
Anxiety and Distress Levels in Women With Suspected Endometrial Cancer
An observational study of Endometrial Cancer and Cancer, run by Imperial College London at 1 site in United Kingdom.
Trial summary
Patients attending the rapid access gynaecology clinic with a suspicion of endometrial cancer are understandably nervous. Few studies have quantified anxiety and distress of patients in this group. This study surveys anxiety and stress levels of women attending clinic (by filling in an anonymous questionnaire). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer, Cancer, Uterine Cancer
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2018to 1 Aug 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All women attending Rapid access gynaecology clinic in imperial College NHS trust
Who may be able to join
- All women presenting to rapid access gynaecology clinic with suspected gynaecological cancer
Who cannot join
- Anyone lacking capacity.
- <18years old.
- Pregnant.
- Anyone unable to understand English (in absence of translator)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Charlotte and Hammersmith Hospital
London, W12 0HS
About this study
Official title: Anxiety and Distress Levels in Women With Suspected Endometrial Cancer Seen in the Rapid Access Gynaecology Clinic
Patients attending the rapid access gynaecology clinic with a suspicion of endometrial cancer are understandably nervous. Few studies have quantified anxiety and distress of patients in this group.
This study surveys anxiety and stress levels of women attending clinic (by filling in an anonymous questionnaire). Additionally, in women who need a tissue biopsy, women are asked to rate their pain scores.
Read the detailed description
Aims:
Quantify the anxiety and stress levels of women attending the Rapid access gynaecology clinic with a suspicion of cancer
Background:
Endometrial cancer is a tumour originating in the endometrium (womb lining); it is the most common gynaecological cancer in the United Kingdom (UK). In 2012, there were almost 100,000 new cases diagnosed in Europe. Endometrial cancer classically presents with postmenopausal bleeding (bleeding after the menopause), or intermenstrual bleeding (bleeding in between periods).
Although routine management for these women does vary, in general a screening test is performed, typically a pelvic (internal) ultrasound to assess the endometrium (womb lining). In cases where the endometrial thickness is above the threshold for investigation -an endometrial biopsy (sampling cells from the womb lining) is indicated. Whilst well tolerated, this can be quite painful.
Once the endometrial biopsy is performed, it is sent to the histologist for further examination. Histological analysis may take several days and patients are either brought back to clinic for discussion of the results or are given a telephone appointment. The patient often will not know the result of the test for up to 2 weeks; thus causing a lot of unnecessary anxiety and distress.
The study:
Patients attending the Rapid Access Gynaecology Clinic will be invited to participate in the study by filling in a short anonymous survey.
Additionally, patients undergoing a tissue biopsy sample will be asked to provide a pain score, followed by a brief interview to ascertain if they would undergo the procedure again if it was needed and how they tolerated the procedure. Additionally, the time taken to perform the procedure will be recorded.
- Conditions
- Endometrial Cancer, Cancer, Uterine Cancer, Anxiety, Stress, Psychological
- Keywords
- endometrial cancer, cancer, uterine cancer, anxiety, stress, psychological, survey, point-of-care
- Medical subject headings
- Endometrial Neoplasms, Neoplasms, Uterine Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| All patients attending Rapid access Gynaecology Clinic | All patients attending Rapid access Gynaecology Clinic for the first time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Score for Patients Attending Clinic
GAD 7 score - (Generalised Anxiety Disorder assessment 7 score). 7 items each measured and score summated. Scale 0-21.Cut offs 0-5, 6-10, 11-15, 16+ correlate with anxiety score. Higher levels = worse anxiety
Measured: Immediately before clinic (waiting room)
Secondary outcomes (2)
Pain Score if Needing a Tissue Biopsy
Patients asked to rank Pain score (using visual analogue score standardised tool), 0 to 10 score, where 0 is no pain and 10 is the worst pain in their life.
Measured: Immediately after tissue sample taken.
Time Taken for Tissue Sample to be Performed
Measure time taken to perform tissue sample (in minutes) from insertion to removal of speculum.
Measured: During tissue biopsy time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start1 Jul 2018
- Primary completion1 Jul 2019
- Study completion1 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe 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
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03813719
- Sponsor's protocol ID
- 16HH3687 Psych Study EC
- Status last verified
- Jul 2020
- First submitted
- 18 Jan 2019
- Last updated
- 14 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anxiety and Distress Levels in Women With Suspected Endometrial Cancer Seen in the Rapid Access Gynaecology Clinic
- ClinicalTrials.gov ID
- NCT03813719
- Acronym / sponsor ID
- 16HH3687 Psych Study EC
- Conditions
- Endometrial Cancer, Cancer, Uterine Cancer, Anxiety, Stress, Psychological
- Keywords
- endometrial cancer, cancer, uterine cancer, anxiety, stress, psychological, survey, point-of-care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Aug 2019 (actual)
- First posted
- 23 Jan 2019 (actual)
- Results
- Posted 14 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients attending the rapid access gynaecology clinic with a suspicion of endometrial cancer are understandably nervous. Few studies have quantified anxiety and distress of patients in this group.
This study surveys anxiety and stress levels of women attending clinic (by filling in an anonymous questionnaire). Additionally, in women who need a tissue biopsy, women are asked to rate their pain scores.
Detailed description
Aims:
Quantify the anxiety and stress levels of women attending the Rapid access gynaecology clinic with a suspicion of cancer
Background:
Endometrial cancer is a tumour originating in the endometrium (womb lining); it is the most common gynaecological cancer in the United Kingdom (UK). In 2012, there were almost 100,000 new cases diagnosed in Europe. Endometrial cancer classically presents with postmenopausal bleeding (bleeding after the menopause), or intermenstrual bleeding (bleeding in between periods).
Although routine management for these women does vary, in general a screening test is performed, typically a pelvic (internal) ultrasound to assess the endometrium (womb lining). In cases where the endometrial thickness is above the threshold for investigation -an endometrial biopsy (sampling cells from the womb lining) is indicated. Whilst well tolerated, this can be quite painful.
Once the endometrial biopsy is performed, it is sent to the histologist for further examination. Histological analysis may take several days and patients are either brought back to clinic for discussion of the results or are given a telephone appointment. The patient often will not know the result of the test for up to 2 weeks; thus causing a lot of unnecessary anxiety and distress.
The study:
Patients attending the Rapid Access Gynaecology Clinic will be invited to participate in the study by filling in a short anonymous survey.
Additionally, patients undergoing a tissue biopsy sample will be asked to provide a pain score, followed by a brief interview to ascertain if they would undergo the procedure again if it was needed and how they tolerated the procedure. Additionally, the time taken to perform the procedure will be recorded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients attending Rapid access Gynaecology Clinic | – | –All patients attending Rapid access Gynaecology Clinic for the first time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All women attending Rapid access gynaecology clinic in imperial College NHS trust
Key inclusion criteria (1 listed)
- All women presenting to rapid access gynaecology clinic with suspected gynaecological cancer
Key exclusion criteria (4 listed)
- Anyone lacking capacity.
- <18years old.
- Pregnant.
- Anyone unable to understand English (in absence of translator)
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
Anxiety Score for Patients Attending Clinic
Time frame: Immediately before clinic (waiting room)
GAD 7 score - (Generalised Anxiety Disorder assessment 7 score). 7 items each measured and score summated. Scale 0-21.Cut offs 0-5, 6-10, 11-15, 16+ correlate with anxiety score. Higher levels = worse anxiety
2 secondary outcomes
Pain Score if Needing a Tissue Biopsy
Time frame: Immediately after tissue sample taken.
Time Taken for Tissue Sample to be Performed
Time frame: During tissue biopsy time
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Endometrial Cancer
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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 Endometrial Cancer and Cancer, run by Imperial College London at 1 site in United Kingdom.
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 1 inclusion and 4 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 14 Jul 2020. 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 United Kingdom. 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?
Yes. Results are posted in the registry (first posted 14 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Anxiety Score for Patients Attending Clinic (time frame: Immediately before clinic (waiting room)). 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 14 Jul 2020.