The Psychological Impact of GTN on Women Who Have Completed Chemotherapy Treatment
Conditions: Gestational Trophoblastic Neoplasia
Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Protocol v1:0 STH22800 IRAS 331718 28/07/2023 
 
 
 
 
Project Ɵtle: The psychological impact of GTN on women who have completed chemotherapy 
treatment  
Chief InvesƟgator/PI: Kam Singh  
Nurse Consultant                                                                                                                                                                                   
1st ﬂoor Broomcross Building                                                                                                                          
Weston Park hospital                                                                                                                                  
Sheﬃeld Teaching Hospitals NHS Trust                                                                                                                 
0114 2265274                                                                                                                                                       
Email: kamaljitsingh@nhs.net 
 
Co-InvesƟgators 
Clare Warnock, Researcher in Cancer Experience 
Jane Ireson, Researcher in Cancer Experience and NHIR research fellow/GTD CNS 
Sarah GilleƩ, GTD/Clinical Nurse Specialist 
Sarah Rollins, GTD/ACP 
Joanna Ronksley, GTD/Clinical Nurse Specialist secondment  
MaƩ Winter, Medical Consultant Oncologist 
 
Sponsor: 
Sheﬃeld Teaching Hospital NHS FoundaƟon Trust 
 
STH Project Reference number: STH22800                                                                                                                   
 
Protocol version:                                                                                                                                                              
1:0 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol v1:0 STH22800 IRAS 331718 28/07/2023 
Project Ɵtle:  
The psychological impact of GTN on women who have completed chemotherapy treatment  
 
Research quesƟon:  
What is the psychological impact on women with GTN who have completed chemotherapy 
treatment?  
 
ObjecƟves: 
 
Gaining insight into the emoƟonal impact of GTN post treatment 
 
Ascertaining if health professionals are providing adequate psychological support 
 
IdenƟfying sources of support that paƟents accessed post compleƟon of treatment 
 
IdenƟfying potenƟal areas of improvement in the follow up support for future paƟents 
 
Abstract: 
GestaƟonal TrophoblasƟc Neoplasia is highly curaƟve but can have psychological consequences for 
women due to the nature of the diagnosis. LiƩle is known about the psychological impact of 
diagnosis and treatment experienced by women following the compleƟon of treatment.  As the 
specialist centre for GTN in the North of the UK, it is important to understand the experiences and 
care needs of our paƟents. The aim of the study is to explore women’s experiences following 
treatment, how they managed any negaƟve impacts and invesƟgate if there is gap in the follow up 
support provided to paƟents aŌer treatment.   
 
The study aims to have 20 parƟcipants who received chemotherapy. Semi-structured telephone 
interviews will be conducted; each interview will be digitally recorded and transcribed verbaƟm. 
ThemaƟc analysis will be used to generate in depth descripƟons of the paƟents experiences. The 
ﬁndings will enable health care professionals working closely with this unique group of paƟents to 
gain some understanding of the paƟent perspecƟve; recommendaƟons will be made to improve the 
support and provision of care these paƟents receive aŌer their treatment has completed. 
 
Aim: 
The aim of the study is to explore the experiences of women with GTN following compleƟon of 
chemotherapy  
 
Background: 
GestaƟonal TrophoblasƟc Neoplasia (GTN) encompasses pregnancy related tumours including 
invasive mole, choriocarinoma and placental site trophoblasƟc tumours. PaƟents are registered and 
treated at one of the two only treatment centres in the UK, Charing Cross Hospital, in London and 
Sheﬃeld TrophoblasƟc Disease Centre, in Sheﬃeld. The biomarker used to measure the disease is 
human chorionic gonadotropin (hCG). PaƟents undergo chemotherapy treatment over several 
months or, unƟl their biomarker is normal and a further 6 weeks from normalisaƟon. The 
InternaƟonal FederaƟon of Gynaecology and Obstetrics (FIGO 2000) scoring system is used to guide 
ﬁrst line treatment decisions, a score of 0-6 categorises the paƟent as low risk and aims to predict a 
lower chance of developing resistance to ﬁrst line treatment, and paƟents are treated with single-
agent chemotherapy. A score of 7 or above is categorised as high risk with almost no chance of 
complete hCG response to single agent chemotherapy, and therefore paƟents are recommended 
combinaƟon chemotherapy from the outset (Winter et al 2016).  
 
Overall GTN has a high cure rate of more than 95% even in the presence of metastaƟc disease 
(Sarwar 2004). However, the psychological burden of the disease can be challenging, as most 

Protocol v1:0 STH22800 IRAS 331718 28/07/2023 
paƟents will have had a much-wanted pregnancy which turns into a cancer diagnosis, or they may 
have given birth and are then faced with intensive treatment over several months, added with 
travelling to the treatment centre miles from their home and the disrupƟon to the family unit (Singh 
et al 2017).  
 
Support is provided during treatment with the clinical nurse specialists playing an integral role in 
providing psychological support. GestaƟonal TrophoblasƟc Disease (GTD) specialist nurses provide 
holisƟc packages of care to help women face the numerous psychosocial challenges of their 
diagnosis (Ireson and Singh 2022). There is much evidence on supporƟng paƟents and families with 
the psychosocial impact of cancer during treatment and this has been branched out to survivorship 
as many more paƟents are living longer aŌer their cancer diagnosis (ReckliƟs and Syrjala 2017). 
According to Loƞi-Jam et al (2019) the period immediately aŌer treatment can be distressing but 
most paƟents will not require intense long-term care, but it is criƟcal to assess the unmet needs to 
prepare survivors of what to expect.  
 
A very early study in GTD provides insight into the complex survivorship relaƟonship between QOL 
and GTN (Wenzel et al 2002). They found that over 50% of respondents would have liked to engage 
in a counselling program to discuss their psychosocial issues raised by the diagnosis. Later studies 
showed that women scored lowest for their psychological health (Ferreira et al 2009) especially 
those receiving chemotherapy (Peterson et al 2005). In the GTD service we have established online 
support groups, electronic PaƟent Reported Outcome Measures (ePROM) and nurse led clinics for 
paƟents who have completed treatment. Some evaluaƟon of these services has been carried out but 
understanding experiences of the psychological impact of GTN from the perspecƟve of paƟents will 
help to idenƟfy if there are any unmet needs that could be met by the GTD mulƟdisciplinary team.   
 
LiƩle research aƩenƟon has been given to the psychological needs of paƟents following the 
compleƟon of their treatment. This study aims to explore this in more depth.  
 
Plan of invesƟgaƟon: 
Methodology 
A cross-secƟonal retrospecƟve study of a sample of 20 women who completed single agent or mulƟ 
agent chemotherapy: between 6 weeks and 24 months post treatment involving a semi structured 
telephone interview.  This is felt to be appropriate as this topic has received very liƩle research 
aƩenƟon for this rare disease and the study aims to capture the paƟents’ own descripƟons of their 
symptoms and experiences. The Ɵmeline will capture diﬀerent perspecƟves from the varying 
treatments that paƟents received, this may provide valuablet insight into paƟent experiences during 
diﬀerent Ɵme points. 
 
Telephone interviews will be conducted to gain insight into the paƟent’s experiences. The raƟonale 
for using the telephone method is based on the geographical locaƟon of our paƟents.  It is not 
feasible for the invesƟgators to travel to individual homes to conduct the interviews or ask paƟents 
to travel.  This method has the advantage in that it is relaƟvely inexpensive.  The telephone interview 
oﬀers a robust method of eliciƟng informaƟon from paƟents about the quality of their care which 
could help to design improved services. The telephone interviews were designed following 
discussions with the clinical team and with the aim of answering the research quesƟon. 
 
Seƫng                                                                                                                                                                              
All interviews will be recorded via telephone and take place at Weston Park Hospital. The principal 
invesƟgator will be responsible for negoƟaƟng dates and Ɵmes of the interview and contacƟng the 

Protocol v1:0 STH22800 IRAS 331718 28/07/2023 
parƟcipants the day before to ensure they are sƟll available for the scheduled interview.  The 
principal invesƟgator will ensure a designated quiet room is available for the interviews without any 
interrupƟons.  Each interview will be digitally recorded and transcribed verbaƟm using an external 
company- Lawson Hardwick Limited 1st class secretarial services. An hour will be allocated for each 
interview. 
 
Sample 
A paƟent sample of 20 is proposed for the study. These are all the paƟents who meet the inclusion 
criteria below and are thus eligible for the study. These paƟents will be contacted via telephone by 
the principal invesƟgator to inform them of the study and invite parƟcipaƟon.  A proposal of 20 is 
suﬃcient to generate data to address the central quesƟons and furthermore, this sample size is 
adequate because the intenƟon is to gain insight into the experiences of paƟents’ percepƟons about 
their psychological experiences. 
 
Criteria for inclusion: 
- 
Treated with chemotherapy for a GTN diagnosis 
- 
Completed treatment between 6 weeks and 24 months 
- 
Are able to provide informed consent 
- 
Have no cogniƟve impairment as judged by the treaƟng clinician 
 
Criteria for exclusion 
- 
Treatment received less than 6 weeks ago 
- 
Treatment received more than 24 months ago 
- 
Non-English speaking 
 
Recruitment  
Each of the parƟcipants will receive a wriƩen informaƟon leaﬂet via email with the details of the 
nature of study and a wriƩen consent form for them to sign and return. The principal invesƟgator will 
be responsible for contacƟng the paƟents once the consent forms have been returned to discuss the 
study and answer any quesƟons. The interview schedule will be sent prior to the interviews.  This will 
enable them to think about what they would like to say, and importantly, oﬀer them the opportunity 
to tell their experience in depth.   
 
 
IntervenƟon  
PaƟents are selected as potenƟal parƟcipants from the GTN database by the principal invesƟgator  
 
 
PaƟents are contacted by the principal invesƟgaƟon via telephone to invite them to the study  
 
 
PaƟents are emailed the informaƟon leaﬂet along with the wriƩen consent form to return back 
 
 
If the paƟents consent to parƟcipate in the study the chief invesƟgator will contact parƟcipants to 
discuss the study and email the interview schedule  
 
 
An interview will be arranged at a Ɵme and date convenient to both the paƟent and the invesƟgator  

Protocol v1:0 STH22800 IRAS 331718 28/07/2023 
 
Outcome measures                                                                                                                                  
Outcome measures are not appropriate in this qualitaƟve study.  However outputs from this study 
include increasing knowledge and insight into: 
• paƟents’ experiences of their psychological experiences post chemotherapy 
• paƟents’ perspecƟve of the support received aŌer their treatment 
• potenƟal areas of improvements in care  
 
 
 
 
 
 
 
Analysis  
ThemaƟc analysis will be used to generate in depth descripƟons of the paƟents experiences. This 
process of analysis involves looking for themes which are present in the interviews and making 
comparisons and contrasts between the diﬀerent respondents. The themaƟc analysis will be carried 
out by three invesƟgators.  Independent analysis will be carried out separately then meeƟngs will be 
scheduled to analyse and discuss any agreements and discrepancies to ensure reliability of the 
interpretaƟons of the data. 
 
Data CollecƟon 
Data will be collected using telephone semi structured interviews; the interview schedule was 
developed using the experƟse from the research team and on the basis of the aims of the study.  
 
Project management                                                                                                                                           
Overall day to day running of the project will rest jointly with the named CI (KS) and clinical nurse 
specialists within the team (SR, JR, SG). The CI (KS) will also coordinate all regulatory/ethics approvals 
and take overall responsibility for all aspects of the study including the management, recruitment 
targets, ﬁnancial management and for ensuring project milestones are achieved. A Project Advisory 
Group will be established comprising the listed invesƟgators. The Project Advisory Group will meet 3 
monthly to discuss the progress of the study. The interviews will be undertaken by SG, SR, JR and CW. 
Interview transcripts will be undertaken by an external company. Analysis will be undertaken by KS, 
CW and JI. KS, CW and JI will be involved in wriƟng the ﬁndings and MCW will oversee the project. 
 
 
Project Ɵmescale 
Year 
 
Month AcƟvity 
 
2023 
 
June  
Literature research     
2023 
 
July 
Complete protocol and IRAS applicaƟon to obtain REC and R&D  
 
 
 
authorisaƟon 
2024 
 
Jan 
Select potenƟal parƟcipants suitable for the study 
2024 
Feb 
Send consent forms and paƟent informaƟon to paƟents who have agreed to 
 
 
parƟcipant                            
2024 
 
March Commence interviews 
2024 
 
May 
Transcribe all the interviews  
2024 
 
June 
Analysis of data                       
2024 
 
Aug 
Write up study 
2024 
 
Oct 
Present the study at ISSTD world congress 
 
ExperƟse of the researcher and associated team     
Associate team –  Sarah GilleƩ (SG), Sarah Rollins (SR), Joanna Ronksley (JR). Clare Warnock (CW), 
Jane Ireson (JI), MaƩ Winter (MW).                                                                                                                                                   

Protocol v1:0 STH22800 IRAS 331718 28/07/2023 
The chief invesƟgator has been the lead nurse for the Sheﬃeld centre since May 2013 and appointed 
nurse consultant in January 2023.  She has wide experience in oncology nursing which has enabled 
her to provide paƟents with the care and support they need. KS has previous experience in 
qualitaƟve research with one study which speciﬁcally explored the paƟent’s experiences of their 
illness using interview methodology as well as a recent study exploring paƟents menopausal 
symptoms post chemotherapy for GTN. 
JR, SR and SG all have experƟse in oncology nursing. SG has been the GTN specialist nurse for the last 
12 years. JI has also been a GTN clinical nurse specialist for 13 years and is currently a research fellow 
undertaking her PhD developing a health related quesƟonnaire speciﬁcally for GTN paƟents. She has 
also has experience in undertaking interview methodology. MW is a Consultant Medical Oncologist, 
Honorary Reader in Medical Oncology and Yorkshire Cancer Research NHS Academy fellow and 
specialises in the treatment of GTN and is also an acƟve clinical researcher with many peer reviewed 
publicaƟons in both GTN and Breast cancer. CW has a wealth of research undertaking numerous 
qualitaƟve studies using telephone interviews in oncology nursing. 
 
Ethical and safety issues  
The risks associated with this project are minimal. There are no medical or invasive procedures 
involved. Therefore, this study does not envisage any harm to be caused to the parƟcipant and it is 
unlikely that the study will encounter any adverse events. It is felt that contacƟng the paƟents to 
invite them to parƟcipate is a jusƟﬁed method because the centre has built an excellent rapport with 
their paƟents.  These paƟents received treatment at Weston Park Hospital over a number of months; 
over this period, they have built good trusƟng relaƟonships with their clinical nurse specialists.  
Furthermore, these paƟents conƟnue to be followed up in clinic and via telephone aŌer the 
treatment has completed. It is possible that the nature of data collecƟon, focusing on personal 
experiences, may result in some distress to some parƟcipants. Both the clinical and research team 
have extensive experience of caring for paƟents with cancer.  The researchers have relevant 
experience in working in cancer care and are skilled at talking to paƟents and will be able to 
recognise paƟent distress. If necessary, and with the paƟents consent, other supporƟve networks will 
be made available. The research team will have direct access to the clinical nurse specialist team and 
be able to refer paƟents back to their allocated CNS (with the parƟcipant’s consent).  
 
 
PaƟents who agree to parƟcipate in the study will be emailed an informaƟon sheet explaining the 
nature of the study and what it entails. ParƟcipants will need to sign and return the consent form. 
We are aware there may be recall bias as some paƟents who received treatment almost 24 months 
ago may not have any symptoms, or not recall in detail compared to those paƟents who have 
completed their treatment less than 6 months ago. The use of telephone and email is deemed 
appropriate as paƟents oŌen use this method to contact their nursing team and all emails are 
provided on registraƟon. 
 
There is a potenƟal that during the interview a parƟcipant menƟons an aspect of care that raises 
concern regarding care quality, client safety or negligence. If this occurs the study team member will 
act accordingly, and act follow refer back to the appropriate service provider or care professional.   
 
 
Subject Withdrawal: 
ParƟcipants will be able to withdraw from the study at any point; their data will be disposed of using 
the trust guidelines. If there is suﬃcient data generated then the study will conƟnue.  
 

Protocol v1:0 STH22800 IRAS 331718 28/07/2023 
 
ConﬁdenƟality 
All study data including the interview recordings and transcripƟons will be idenƟﬁable only by an ID 
number which will be assigned on signing the consent form.  Any idenƟfying details will be removed 
and the transcripƟons will be anonymous.  The data will be stored securely and conﬁdenƟally.  The 
interviews will be conducted in a private quiet room. All study data will be stored securely and 
conﬁdenƟally in accordance with the Data ProtecƟon Act 2018.  The data will be kept in locked 
cupboards and on password protected computers at each of the Trust’s centres.  The data will be 
securely kept for future research on the Trust’s computer with a secured password. 
 
Involvement of service users: 
Two paƟents who will not be parƟcipaƟng in the study have been involved in reviewing the interview 
quesƟons.  
 
Strategy for taking the work forward if the research project is producƟve:                                                    
The results will be disseminated within the MDT and presented at the next European meeƟng and 
InternaƟonal Society for the Study of TrophoblasƟc Diseases conference in 2024.  The ﬁndings will 
enable health care professionals working closely with this unique group of paƟents to gain some 
understanding of the paƟent perspecƟve and importantly improve the paƟent experience, 
furthermore, gaining a close insight and improving their own knowledge.  
 
Intellectual property arrangements:                                                                                    
The intellectual property arrangements will be standard for research conducted in the NHS and 
funded within charitable sources. 
 
CosƟng the project:                                                                                                                   
1st class secretarial services £1500.00 plus VAT (based on 20 interviews approximately 1 hour each).  
Funding source:                                                                                                                       
Research charity, ‘Jean’s Research Trust’. This study will be carried out by the invesƟgators in their 
own employment within their current roles. 
 
End of study deﬁniƟon 
The study will end when all the data is analysed. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Protocol v1:0 STH22800 IRAS 331718 28/07/2023 
 
 
REFERENCES 
FIGO Oncology CommiƩee, FIGO (2002) Staging for gestaƟonal trophoblasƟc neoplasia 2000. Int J  
Gynaecol Obstet 77(3):285-287.  
 
Ireson, J & Singh, K. (2022) HolisƟc Models of Care in GestaƟonal TrophoblasƟc Disease: An 
InternaƟonal PerspecƟve. In GestaƟonal TrophoblasƟc Disease 5th EdiƟon, Hancock BW, Seckl MJ 
and Berkowitz RS. Available at  hƩps://isstd.org/gtd-book.html 
 
LoŌi-Jam K, Gough K, Schoﬁeld P, Aranda M, Jeﬀord, M. A longitudinal study of four unique 
trajectories of psychological distress in cancer survivors aŌer compleƟng potenƟally curaƟve 
treatment. Acta Oncologica, 2019: 58(5), PP.782-789. 
 
Petersen, R.W., Ung, K., Holland, C. and Quinlivan, J.A. The impact of molar pregnancy on 
psychological symptomatology, sexual funcƟon, and quality of life. Gynecologic oncology, 2005: 
97(2), pp.535-542. 
 
ReckliƟs CJ, KL Syrjala KL. Provision of integrated psychosocial services for cancer survivors post-
treatment. The Lancet Oncology, 2017: 18(1),pp.e39-50. 
 
Sarwar N, Newlands E, Seckl M (2004). GTN management of relapsing paƟents. Current oncology 
reports.  6: p476-482.  
 
Singh K, Warnock C, Ireson J, et al. (2017). The experience of women with gestaƟonal trophoblasƟc 
neoplasia treated with high dose chemotherapy and stem cell rescue; a qualitaƟve study. Oncol Nurs 
Forum.  44: 375–83. 
 
Wenzel, L., Berkowitz, R. S., Newlands, E., Hancock, B., Goldstein, D. P., Seckl, M. J, et al. 2002). 
Quality of life aŌer gestaƟonal trophoblasƟc disease. Journal of ReproducƟve Medicine, 47(5), 387–
394. 
 
Winter MC, Tidy JA,  Hills A et al (2016) Risk adapted single-agent dacƟnomycin or carboplaƟn for  
second-line treatment of methotrexate resistant low-risk gestaƟonal trophoblasƟc neoplasia.  
Gynecologic Oncology 143(3):565-570. hƩps://doi.org/10.1016/j.ygyno.2016.10.001