Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06169644 |
| Other study ID # |
STH22800 |
| Secondary ID |
331718 |
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
April 22, 2024 |
| Est. completion date |
December 30, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Sheffield Teaching Hospitals NHS Foundation Trust |
| Contact |
Kamaljit Singh |
| Phone |
01142265274 |
| Email |
kamaljitsingh[@]nhs.net |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
A cross-sectional retrospective study of a sample of 20 women who completed single agent or
multi agent chemotherapy: between 6 weeks and 24 months post treatment involving a semi
structured telephone interview. A patient sample of 20 is proposed for the study. These are
all the patients who meet the inclusion criteria below and are thus eligible for the study.
These patients will be contacted via telephone by the principal investigator to inform them
of the study and invite participation. A proposed sample size of 20 is sufficient to generate
data to address the central questions and furthermore, this sample size is adequate because
the intention is to gain insight into the experiences of patients' perceptions about their
psychological experiences.
Objectives:
- Gaining insight into the emotional impact of GTN post treatment
- Ascertaining if health professionals are providing adequate psychological support
- Identifying sources of support that patients accessed post completion of treatment
- Identifying potential areas of improvement in the follow up support for future patients
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 cognitive impairment as judged by the treating clinician
Criteria for exclusion
- Treatment received less than 6 weeks ago
- Treatment received more than 24 months ago
- Non-English speaking
Outcome measures are not appropriate in this qualitative study. However outputs from this
study include increasing knowledge and insight into:
- patients' experiences of their psychological experiences post chemotherapy
- patients' perspective of the support received after their treatment
- potential areas of improvements in care
Description:
Research question:
What is the psychological impact on women with GTN who have completed chemotherapy treatment?
Objectives:
- Gaining insight into the emotional impact of GTN post treatment
- Ascertaining if health professionals are providing adequate psychological support
- Identifying sources of support that patients accessed post completion of treatment
- Identifying potential areas of improvement in the follow up support for future patients
Abstract:
Gestational Trophoblastic Neoplasia is highly curative but can have psychological
consequences for women due to the nature of the diagnosis. Little is known about the
psychological impact of diagnosis and treatment experienced by women following the completion
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 patients. The aim of the study is to explore
women's experiences following treatment, how they managed any negative impacts and
investigate if there is gap in the follow up support provided to patients after treatment.
The study aims to have 20 participants who received chemotherapy. Semi-structured telephone
interviews will be conducted; each interview will be digitally recorded and transcribed
verbatim. Thematic analysis will be used to generate in depth descriptions of the patients
experiences. The findings will enable health care professionals working closely with this
unique group of patients to gain some understanding of the patient perspective;
recommendations will be made to improve the support and provision of care these patients
receive after their treatment has completed.
Aim:
The aim of the study is to explore the experiences of women with GTN following completion of
chemotherapy
Plan of investigation:
Methodology A cross-sectional retrospective study of a sample of 20 women who completed
single agent or multi 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 little research attention for this rare disease and the study aims to
capture the patients' own descriptions of their symptoms and experiences. The timeline will
capture different perspectives from the varying treatments that patients received, this may
provide valuablet insight into patient experiences during different time points.
Telephone interviews will be conducted to gain insight into the patient's experiences. The
rationale for using the telephone method is based on the geographical location of our
patients. It is not feasible for the investigators to travel to individual homes to conduct
the interviews or ask patients to travel. This method has the advantage in that it is
relatively inexpensive. The telephone interview offers a robust method of eliciting
information from patients 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 question.
Setting All interviews will be recorded via telephone and take place at Weston Park Hospital.
The principal investigator will be responsible for negotiating dates and times of the
interview and contacting the participants the day before to ensure they are still available
for the scheduled interview. The principal investigator will ensure a designated quiet room
is available for the interviews without any interruptions. Each interview will be digitally
recorded and transcribed verbatim using an external company- Lawson Hardwick Limited 1st
class secretarial services. An hour will be allocated for each interview.
Sample A patient sample of 20 is proposed for the study. These are all the patients who meet
the inclusion criteria below and are thus eligible for the study. These patients will be
contacted via telephone by the principal investigator to inform them of the study and invite
participation. A proposal of 20 is sufficient to generate data to address the central
questions and furthermore, this sample size is adequate because the intention is to gain
insight into the experiences of patients' perceptions 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 cognitive impairment as judged by the treating 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 participants will receive a written information leaflet via email
with the details of the nature of study and a written consent form for them to sign and
return. The principal investigator will be responsible for contacting the patients once the
consent forms have been returned to discuss the study and answer any questions. 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.
Intervention:
- Patients are selected as potential participants from the GTN database by the principal
investigator
- Patients are contacted by the principal investigation via telephone to invite them to
the study
- Patients are emailed the information leaflet along with the written consent form to
return back
- If the patients consent to participate in the study the chief investigator will contact
participants to discuss
- An interview will be arranged at a time and date convenient to both the patient and the
investigator
Outcome measures Outcome measures are not appropriate in this qualitative study. However
outputs from this study include increasing knowledge and insight into:
- patients' experiences of their psychological experiences post chemotherapy
- patients' perspective of the support received after their treatment
- potential areas of improvements in care
Analysis Thematic analysis will be used to generate in depth descriptions of the patients
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
thematic analysis will be carried out by three investigators. Independent analysis will be
carried out separately then meetings will be scheduled to analyse and discuss any agreements
and discrepancies to ensure reliability of the interpretations of the data.
Data Collection Data will be collected using telephone semi structured interviews; the
interview schedule was developed using the expertise from the research team and on the basis
of the aims of the study.
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 participant and it is unlikely that the study will encounter any adverse
events. It is felt that contacting the patients to invite them to participate is a justified
method because the centre has built an excellent rapport with their patients. These patients
received treatment at Weston Park Hospital over a number of months; over this period, they
have built good trusting relationships with their clinical nurse specialists. Furthermore,
these patients continue to be followed up in clinic and via telephone after the treatment has
completed. It is possible that the nature of data collection, focusing on personal
experiences, may result in some distress to some participants. Both the clinical and research
team have extensive experience of caring for patients with cancer. The researchers have
relevant experience in working in cancer care and are skilled at talking to patients and will
be able to recognise patient distress. If necessary, and with the patients consent, other
supportive networks will be made available. The research team will have direct access to the
clinical nurse specialist team and be able to refer patients back to their allocated CNS
(with the participant's consent).
Patients who agree to participate in the study will be emailed an information sheet
explaining the nature of the study and what it entails. Participants will need to sign and
return the consent form. It is noted that there may be recall bias as some patients who
received treatment almost 24 months ago may not have any symptoms, or not recall in detail
compared to those patients who have completed their treatment less than 6 months ago. The use
of telephone and email is deemed appropriate as patients often use this method to contact
their nursing team and all emails are provided on registration.
There is a potential that during the interview a participant mentions 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:
Participants 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 continue.
Confidentiality All study data including the interview recordings and transcriptions will be
identifiable only by an ID number which will be assigned on signing the consent form. Any
identifying details will be removed and the transcriptions will be anonymous. The data will
be stored securely and confidentially. The interviews will be conducted in a private quiet
room. All study data will be stored securely and confidentially in accordance with the Data
Protection 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 patients who will not be participating in the study have been involved in reviewing the
interview questions.
Strategy for taking the work forward if the research project is productive:
The results will be disseminated within the MDT and presented at the next European meeting
and International Society for the Study of Trophoblastic Diseases conference in 2024. The
findings will enable health care professionals working closely with this unique group of
patients to gain some understanding of the patient perspective and importantly improve the
patient 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.
End of study definition The study will end when all the data is analysed.
