Gynaecological CancerNCT04839874
Health Seeking Behaviour in Women Diagnosed With Gynaecological Cancer: Can it be Modified to Improve Patient Outcomes?
An observational study of Gynaecological Cancer, run by NHS Grampian at 1 site in United Kingdom.
Trial summary
This study will focus on speaking to women who have been diagnosed with one of the five main gynaecological cancers: ovarian, endometrial (womb), cervical, vulval and vaginal. Too many women are dying from gynaecological cancer in the UK. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Gynaecological Cancer
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Mar 2021to 31 Mar 2023
- 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 to 100 years
- Women only
- Adult, Older adult
Study population: Women who have been diagnosed with a gynaecological cancer
Who may be able to join
- Clinical diagnosis of gynaecological cancer
Who cannot join
- Non-English speaking participants
- Cognitive impairment
- Terminal stage of illness
- Diagnosis through screening programmes
Trial locations and contacts
1 site in 1 country.
About this study
This study will focus on speaking to women who have been diagnosed with one of the five main gynaecological cancers: ovarian, endometrial (womb), cervical, vulval and vaginal. Too many women are dying from gynaecological cancer in the UK. There are many reasons for this, but the study investigators think that embarrassment might be one of the reasons. It can be embarrassing to talk about gynaecological cancers or the symptoms that they cause. This might lead some women to delay going to their doctor when they have symptoms. This study will speak with women who have been diagnosed with a gynaecological cancer to ask them what they did before they were diagnosed; when did they realise something was wrong; what made them go to their doctor; did having gynaecological symptoms make them think differently about going to the doctor? This information will be used to find ways of making it as easy as possible for women to go to their doctors as early as possible. This will hopefully see fewer women dying from these cancers.
Read the detailed description
The study will explore the research questions using qualitative semi-structured interviews with women diagnosed with gynaecological cancer. A study information sheet, reply slip and a reply-paid envelope will be sent to eligible patients by their secondary care clinician, with reminders sent after two weeks. Recruitment and interviewing will take place until data saturation occurs (three interviews with no new shared beliefs) on the main themes. Interviews will take place at a mutually convenient time and place, ideally face to face but could be conducted over the telephone if preferred by the interviewee or if social distancing measures are still in place due to Covid-19. Further verbal and written information regarding the study will be provided prior to interview commencement and participants will be given the opportunity to ask questions. Those agreeing to take part in a face to face interview will sign a consent form in duplicate (one for the participant and one copy for the research team). Those participating in a telephone interview will be read each point of the consent form and asked to agree to each one. This will be recorded, transcribed and used as evidence of consent. Interviews will be conducted flexibly allowing for shorter interviews where necessary and participants will be reminded that the interviews can be terminated at any time. The participant can withdraw from the study at any time: data already collected with consent will be retained and used in the study. No further data will be collected, or any other research procedures carried out on or in relation to the participant. All interviews will be digitally audio recorded and transcribed verbatim by the CI or NHSG approved transcription service. The data will be stored and managed using NVivo software. Interviews will follow a semi-structured topic guide based on the COM-B behaviour change model concepts of capability, opportunity and motivation. Changes can be made to the topic guide as interviews are conducted. Data familiarisation will be by reading and rereading transcripts and by listening to the recorded interviews. Data will be analysed using iterative deductive and inductive methods combining Framework analysis and thematic analysis.
A contact will be provided for patients should they become distressed because of contact by or participation in the study. Although all data collected will stored and analysed with the strictest of confidence in line with the General Data Protection Regulations (2018), if details of any improper conduct or poor practice are disclosed the research team may be obliged to report this. The participant's GP will not be informed. Study participants will have any travel costs reimbursed.
- Conditions
- Gynaecological Cancer
- Being tested
- No intervention
- Keywords
- Health seeking behaviour, Pelvic examination
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Semi-structured qualitative interviews
What is being measured
The primary outcome is the main question the study is designed to answer.
Description of the facilitators and barriers to health seeking behaviour in women diagnosed with gynaecological cancer using semi-structured qualitative interviews.
Semi-structured interviews will be used to explore the facilitators and barriers to health seeking behaviour in women who have been diagnosed with a gynaecological cancer. Analysis will be narrative using both framework and thematic analysis Framework analysis will use the constructs of capability, opportunity and motivation of the COM-B behaviour tool model.
Measured: 2 years
Secondary outcomes (1)
Description of the perceptions of pelvic examination in women diagnosed with gynaecological cancer using semi-structured interviews.
Semi-structured interviews will be used to explore the perceptions to pelvic examination in women who have been diagnosed with a gynaecological cancer. Analysis will be narrative using both framework and thematic analysis Framework analysis will use the constructs of capability, opportunity and motivation of the COM-B behaviour tool model.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start1 Mar 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynaecological CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Grampian
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Pauline Williams, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839874
- Sponsor's protocol ID
- NHS Grampian
- Status last verified
- Nov 2022
- First submitted
- 7 Apr 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Identifiable patient data will not be shared. Interview data will be shared in a report to funders and to peer reviewed journals
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Seeking Behaviour in Women Diagnosed With Gynaecological Cancer: Can it be Modified to Improve Patient Outcomes?
- ClinicalTrials.gov ID
- NCT04839874
- Acronym / sponsor ID
- NHS Grampian
- Conditions
- Gynaecological Cancer
- Keywords
- Health seeking behaviour, Pelvic examination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- NHS GrampianOther government
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 9 Apr 2021 (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.
This study will focus on speaking to women who have been diagnosed with one of the five main gynaecological cancers: ovarian, endometrial (womb), cervical, vulval and vaginal. Too many women are dying from gynaecological cancer in the UK. There are many reasons for this, but the study investigators think that embarrassment might be one of the reasons. It can be embarrassing to talk about gynaecological cancers or the symptoms that they cause. This might lead some women to delay going to their doctor when they have symptoms. This study will speak with women who have been diagnosed with a gynaecological cancer to ask them what they did before they were diagnosed; when did they realise something was wrong; what made them go to their doctor; did having gynaecological symptoms make them think differently about going to the doctor? This information will be used to find ways of making it as easy as possible for women to go to their doctors as early as possible. This will hopefully see fewer women dying from these cancers.
Detailed description
The study will explore the research questions using qualitative semi-structured interviews with women diagnosed with gynaecological cancer. A study information sheet, reply slip and a reply-paid envelope will be sent to eligible patients by their secondary care clinician, with reminders sent after two weeks. Recruitment and interviewing will take place until data saturation occurs (three interviews with no new shared beliefs) on the main themes. Interviews will take place at a mutually convenient time and place, ideally face to face but could be conducted over the telephone if preferred by the interviewee or if social distancing measures are still in place due to Covid-19. Further verbal and written information regarding the study will be provided prior to interview commencement and participants will be given the opportunity to ask questions. Those agreeing to take part in a face to face interview will sign a consent form in duplicate (one for the participant and one copy for the research team). Those participating in a telephone interview will be read each point of the consent form and asked to agree to each one. This will be recorded, transcribed and used as evidence of consent. Interviews will be conducted flexibly allowing for shorter interviews where necessary and participants will be reminded that the interviews can be terminated at any time. The participant can withdraw from the study at any time: data already collected with consent will be retained and used in the study. No further data will be collected, or any other research procedures carried out on or in relation to the participant. All interviews will be digitally audio recorded and transcribed verbatim by the CI or NHSG approved transcription service. The data will be stored and managed using NVivo software. Interviews will follow a semi-structured topic guide based on the COM-B behaviour change model concepts of capability, opportunity and motivation. Changes can be made to the topic guide as interviews are conducted. Data familiarisation will be by reading and rereading transcripts and by listening to the recorded interviews. Data will be analysed using iterative deductive and inductive methods combining Framework analysis and thematic analysis.
A contact will be provided for patients should they become distressed because of contact by or participation in the study. Although all data collected will stored and analysed with the strictest of confidence in line with the General Data Protection Regulations (2018), if details of any improper conduct or poor practice are disclosed the research team may be obliged to report this. The participant's GP will not be informed. Study participants will have any travel costs reimbursed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women who have been diagnosed with a gynaecological cancer
Key inclusion criteria (1 listed)
- Clinical diagnosis of gynaecological cancer
Key exclusion criteria (4 listed)
- Non-English speaking participants
- Cognitive impairment
- Terminal stage of illness
- Diagnosis through screening programmes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionSemi-structured qualitative interviews | Other | – |
Primary outcome
Description of the facilitators and barriers to health seeking behaviour in women diagnosed with gynaecological cancer using semi-structured qualitative interviews.
Time frame: 2 years
Semi-structured interviews will be used to explore the facilitators and barriers to health seeking behaviour in women who have been diagnosed with a gynaecological cancer. Analysis will be narrative using both framework and thematic analysis Framework analysis will use the constructs of capability, opportunity and motivation of the COM-B behaviour tool model.
1 secondary outcome
Description of the perceptions of pelvic examination in women diagnosed with gynaecological cancer using semi-structured interviews.
Time frame: 2 years
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 5 May 2026.
- Individual participant dataSharing planned: No. Identifiable patient data will not be shared. Interview data will be shared in a report to funders and to peer reviewed journals
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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.
Pauline Williams principal investigator
University of Aberdeen
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 Gynaecological Cancer, run by NHS Grampian 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 5 May 2026. 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?
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?
Description of the facilitators and barriers to health seeking behaviour in women diagnosed with gynaecological cancer using semi-structured qualitative interviews. (time frame: 2 years). 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 5 May 2026.