Anxiety and Distress Levels in Women With Suspected Endometrial Cancer Seen in the Rapid Access Gynaecology Clinic
Conditions: Endometrial Cancer, Cancer, Uterine Cancer, Anxiety, Stress, Psychological
Sponsor: Imperial College London

 
 
1/06/2017 
 
 
 
 
 
 
 
 
Anxiety and Distress Levels in Women with Suspected Endometrial 
Cancer 
 
 
 
 
 
 
 
MAIN SPONSOR: Imperial College London 
STUDY COORDINATION CENTRE: Hammersmith Hospital 
NRES reference: 210195 
NCT03813719 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
1/06/2017 
 
Study Management Group 
 
Chief Investigator: Miss Sadaf Ghaem-Maghami (gynaecological oncology consultant) 
 
Miss Diana Marcus (clinical research fellow) 
 
 
Clinical Queries 
 
Clinical queries should be directed to Dr Diana Marcus Clinical Research Fellow, who will 
direct the query to the appropriate person 
 
 
Sponsor 
 
Imperial College London is the main research Sponsor for this study.  For further information 
regarding the sponsorship conditions, please contact the Head of Regulatory Compliance at: 
 
 
 
Joint Research Compliance Office 
Imperial College London & Imperial College Healthcare NHS Trust 
2nd Floor Medical School Building 
St Mary’s Hospital 
Praed Street 
London 
W2 1NY 
Tel: 020759 41862 
 
 
Funder 
 
This protocol describes the aforementioned study and provides information about procedures for 
entering participants.  Every care was taken in its drafting, but corrections or amendments may be 
necessary. These will be circulated to investigators in the study.  Problems relating to this study should 
be referred, in the first instance, to the Chief Investigator.  
 
This study will adhere to the principles outlined in the NHS Research Governance Framework for Health 
and Social Care (2nd edition). It will be conducted in compliance with the protocol, the Data Protection 
Act and other regulatory requirements as appropriate.  
 
 
 

 
 
1/06/2017 
 
Table of Contents 
1. 
INTRODUCTION 
5 
1.1 
BACKGROUND 
5 
2.  STUDY OBJECTIVES 
5 
3.  STUDY DESIGN 
5 
3.1 
MAIN STUDY 
5 
4. 
PARTICIPANT ENTRY 
6 
4.1 
PRE-REGISTRATION EVALUATIONS 
6 
4.2 
INCLUSION CRITERIA 
6 
ALL WOMEN PRESENTING TO RAPID ACCESS GYNAECOLOGY CLINIC WITH POSTMENOPAUSAL 
BLEEDING OR INTERMENSTRUAL BLEEDING 
6 
4.3 
EXCLUSION CRITERIA 
6 
4.4 
WITHDRAWAL CRITERIA 
6 
5. 
ADVERSE EVENTS 
6 
5.1 
DEFINITIONS 
6 
5.3 
REPORTING PROCEDURES 
6 
6. 
ASSESSMENT AND FOLLOW-UP 
7 
7. 
STATISTICS AND DATA ANALYSIS 
7 
8. 
REGULATORY ISSUES 
7 
8.1 
ETHICS APPROVAL 
7 
8.2 
CONSENT 
7 
8.3 
CONFIDENTIALITY 
8 
8.4 
INDEMNITY 
8 
8.5 
SPONSOR 
8 
8.6 
FUNDING 
8 
8.7 
AUDITS 
8 
9. 
STUDY MANAGEMENT 
8 
10. 
PUBLICATION POLICY 
8 
 
 
 

 
 
1/06/2017 
 
GLOSSARY OF ABBREVIATIONS 
PMB 
Post menopausal Bleeding 
IMB 
Intermenstrual Bleeding 
 
KEYWORDS 
 
Innovations 
Endometrial 
Cancer 
Psychological 
Anxiety 
 
STUDY SUMMARY 
 
TITLE Anxiety of women attending rapid access clinic with suspected endometrial cancer 
DESIGN Prospective observational study and study 
AIMS (1) Determine the anxiety levels of women with suspected endometrial cancer 
(2) Determine factors affecting anxiety levels 
  
OUTCOME MEASURES Primary outcome measures:  
(1) Anxiety levels of women with suspected cancer 
 
Secondary outcome measures:  
(1) Factors affecting anxiety level 
 
POPULATION 250 women referred to rapid access clinic with postmenopausal bleeding or 
intermenstrual bleeding.  
 
ELIGIBILITY All women presenting to rapid access gynaecology clinic with 
postmenopausal bleeding or intermenstrual bleeding 
 
EXCLUSION 
 
   DURATION  
Anyone lacking capacity. <18years old. Pregnant. Any contra-indication carry 
out a biopsy 
 
1 year 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
1/06/2017 
 
1. 
INTRODUCTION  
 
1.1 
BACKGROUND 
 
Endometrial cancer is a tumour originating in the endometrium (womb lining); it is the most 
common gynaecological cancer in the UK. In 2012, there were almost 100,000 new cases 
diagnosed in Europe. The lifetime risk of developing endometrial cancer is 1.7%-2.6%. 
Endometrial cancer classically presents with postmenopausal bleeding (bleeding after the 
menopause), or intermenstrual bleeding (bleeding between periods).  
It is well recognised, that cancer has a huge detrimental psychological effect. Few studies 
have investigated stress and anxiety levels in patients with suspected cancer, though it is 
assumed to be high. 
1.2 
RATIONALE FOR CURRENT STUDY 
 
It is assumed that women attending rapid access clinics with suspected cancer are anxious 
and stressed but few studies have investigated this.  
 
2.  STUDY OBJECTIVES 
 
Objectives:  
(1) Determine the anxiety levels of women with suspected endometrial cancer 
(2) Determine factors affecting anxiety levels 
 
3.  STUDY DESIGN 
 
Paired observational study  
Setting: Imperial College NHS Trust Hospitals, London 
Participants:  250 women referred to rapid access clinic with postmenopausal bleeding or 
intermenstrual bleeding.  
Duration: 1 year 
 
3.1 
MAIN STUDY  
 
250 consecutive women presenting to the rapid access clinic with postmenopausal bleeding 
(PMB) and intermenstrual bleeding (IMB) will be approached for consent for inclusion into 
this study.  
Women were given a short 5-minute questionnaire to fill during their first clinic attendance, 
before seeing any clinician or healthcare provider (see appendix for copy of questionnaire).  
The questionnaire had 19 questions, split into 4 broad groups: questions quantifying 
anxiety/stress levels, factors that might affect anxiety levels, patient’s perception of cancer 
diagnosis and the importance of a quick diagnosis. Patients were asked to score how they 
perceived their stress levels using a Likert scale. A score of 4 or above was defined as high 
stress in this study and 3 and below as low stress. Patients were also asked to fill a 
Generalised Anxiety Disorder 7 (GAD 7) form. 
Women were excluded if, in the absence of a translator, they did not have sufficient 
comprehension of English to fill the questionnaire. Patients were also excluded from the 
analysis if they omitted 3 or more answers from the questionnaire.  
 

 
 
1/06/2017 
 
For women needing a pipelle biopsy for clinical indications, the time taken to perform the 
biopsy, from insertion of the speculum to its removal was recorded in minutes, rounded to the 
nearest 30 seconds. Women were asked to rank their pain using a visual analogue score (0 to 
10, where 0 is no pain and 10 is the worst pain in their life). Women were asked if they would 
have this procedure again, if they would recommend it to family or friends should they were 
need it. If women persisted with the procedure, they were asked their motivations for doing 
so, and what coping mechanisms they used. This paired data was matched to the patient’s 
questionnaire responses.  
 
4. 
PARTICIPANT ENTRY  
 
4.1 
PRE-REGISTRATION EVALUATIONS  
No need for any specific screening tests prior to participant entry into the study.  
 
4.2 
INCLUSION CRITERIA 
All women presenting to rapid access gynaecology clinic with postmenopausal bleeding or 
intermenstrual bleeding 
 
4.3 
EXCLUSION CRITERIA 
Anyone lacking capacity. <18years old. Pregnant. Any contra-indication carry out a biopsy 
 
4.4 
WITHDRAWAL CRITERIA 
Withdrawal procedure occurs if patients choose to exit the study or if they loose capacity. 
The clinical details up till the point of withdrawal of the patient from the study will remain on 
file. 
 
5. 
ADVERSE EVENTS 
 
5.1 
DEFINITIONS   
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject.   
 
Serious Adverse Event (SAE): any untoward and unexpected medical occurrence or effect 
that: 
• 
Results in death 
• 
Is life-threatening – refers to an event in which the subject was at risk of death 
at the time of the event; it does not refer to an event which hypothetically might 
have caused death if it were more severe 
 
• 
Requires 
hospitalisation, 
or 
prolongation 
of 
existing 
inpatients’ 
hospitalisation 
• 
Results in persistent or significant disability or incapacity 
• 
Is a congenital anomaly or birth defect 
 
Medical judgement should be exercised in deciding whether an AE is serious in other 
situations.  Important AEs that are not immediately life-threatening or do not result in death or 
hospitalisation but may jeopardise the subject or may require intervention to prevent one of 
the other outcomes listed in the definition above, should also be considered serious. 
 
5.3 
REPORTING PROCEDURES 
All adverse events should be reported.  Depending on the nature of the event the reporting 
procedures below should be followed.  Any questions concerning adverse event reporting 
should be directed to the Chief Investigator in the first instance.   
 
5.3.1 Non serious AEs 

 
 
1/06/2017 
 
All such events, whether expected or not, should be recorded.   
 
5.3.2 Serious AEs 
An SAE form should be completed and faxed to the Chief Investigator within 24 hours.  
However, relapse and death due to endometrial cancer and hospitalisations for elective 
treatment of a pre-existing condition do not need reporting as SAEs. 
 
All SAEs should be reported to the JCRO at Imperial where in the opinion of the Chief 
Investigator, the event was: 
• 
‘related’, ie resulted from the administration of any of the research procedures; 
and 
• 
‘unexpected’, ie an event that is not listed in the protocol as an expected 
occurrence 
 
Reports of related and unexpected SAEs should be submitted within 15 days of the Chief 
Investigator becoming aware of the event, using the NRES SAE form for non-IMP studies.  
The Chief Investigator must also notify the Sponsor of all SAEs. 
 
Local investigators should report any SAEs as required by their Local Research Ethics 
Committee, Sponsor and/or Research & Development Office. 
 
6. 
ASSESSMENT AND FOLLOW-UP  
 
Following the survey/biopsy will continue with routine standard of care and follow up.  
End of trial will be defined as when the last patient for recruitment received her operative 
surgery (and final histology was obtained) and has been followed up for 5 years.  
 
7. 
STATISTICS AND DATA ANALYSIS 
 
Microsoft excel was used to provide the graphs and pie charts for demographics. 
SPSS version 25 was used to perform all the sub analyses. Median, quartile ranges, box and 
whiskers plots were created for each variable. A Mann-Whitney-Wilcox test was used to 
assess for association between each factor and anxiety as measured with GAD 7 score. 
 
Data and all appropriate documentation will be stored for a minimum of 10 years after the 
completion of the study, including the follow-up period.   
 
8. 
REGULATORY ISSUES 
 
8.1 
ETHICS APPROVAL 
The Chief Investigator has obtained approval from the Research Ethics Committee.  The study 
must be submitted for Site Specific Assessment (SSA) at each participating NHS Trust.  The 
Chief Investigator will require a copy of the Trust R&D approval letter before accepting 
participants into the study.  The study will be conducted in accordance with the 
recommendations for physicians involved in research on human subjects adopted by the 18th 
World Medical Assembly, Helsinki 1964 and later revisions. 
 
8.2 
CONSENT  
Consent to enter the study must be sought from each participant only after a full explanation 
has been given, an information leaflet offered and time allowed for consideration.  Signed 
participant consent should be obtained.  The right of the participant to refuse to participate 
without giving reasons must be respected.  After the participant has entered the study the 
clinician remains free to give alternative treatment to that specified in the protocol at any stage 

 
 
1/06/2017 
 
if he/she feels it is in the participant’s best interest, but the reasons for doing so should be 
recorded.  In these cases the participants remain within the study for the purposes of follow-
up and data analysis.  All participants are free to withdraw at any time from the protocol 
treatment without giving reasons and without prejudicing further treatment. 
 
8.3 
CONFIDENTIALITY 
The Chief Investigator will preserve the confidentiality of participants taking part in the study 
and is registered under the Data Protection Act. 
 
8.4 
INDEMNITY 
Imperial College London holds negligent harm and non-negligent harm insurance policies 
which apply to this study/ Imperial College Healthcare NHS Trust holds standard NHS Hospital 
Indemnity and insurance cover with NHS Litigation Authority for NHS Trusts in England, which 
apply to this study (delete as applicable) 
 
8.5 
SPONSOR 
Imperial College London/Imperial College Healthcare NHS Trust (delete as applicable) will act 
as the main Sponsor for this study.  Delegated responsibilities will be assigned to the NHS 
trusts taking part in this study.   
 
8.6 
FUNDING 
We have applied for funding from the wellbeing of women charity.  
 
8.7 
AUDITS  
The study may be subject to inspection and audit by Imperial College London under their remit 
as sponsor and other regulatory bodies to ensure adherence to GCP and the NHS Research 
Governance Framework for Health and Social Care (2nd edition).  
 
 
9. 
STUDY MANAGEMENT 
 
The day-to-day management of the study will be co-ordinated through Dr Diana Marcus, 
clinical research fellow. 
 
 
10. 
PUBLICATION POLICY 
 
The data obtained from this study will be anonymised and analysed. The anonymised data 
will be published in peer-reviewed journals and presented in relevant conferences and at 
patient/public engagement events.