Gynecologic CancersGRACEFULNCT06920342
Attitudes to Gynae Oncology Care Location - GRACEFUL
An observational study of Gynecologic Cancers, run by Somerset NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Gynaecological oncology (cancer) place of care is often based on evolution of services, along historical professional boundaries, rather than user needs or preferences. The investigators aim to gather views of patients in the United Kingdom (UK) on their preferred place of care for investigation, treatment and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancers
- How many people
- 600 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Mar 2025to 2 Feb 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: UK
Who may be able to join
- Female Aged 18 or over Able to give informed consent Have been referred to secondary care with a suspected gynaecological cancer, or have previously been diagnosed with a gynaecological malignancy
Who cannot join
- Male Unable to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Somerset NHS Foundation Trust
Taunton, Somerset, TA1 5DA
Flo Cullen, 01823 342582, flo.cullen@somersetft.nhs.uk
Jo Morrison, Dr, Jo.Morrison@Somersetft.nhs.uk
About this study
Official title: Investigating Attitudes to Gynaecological Rapid Access, Cancer Exclusion and Follow Up Location (GRACEFUL Study)
Gynaecological oncology (cancer) place of care is often based on evolution of services, along historical professional boundaries, rather than user needs or preferences. The investigators aim to gather views of patients in the United Kingdom (UK) on their preferred place of care for investigation, treatment and follow-up of gynaecological cancer. An initial scoping review found no previous work in this area. Pilot work, performed to inform local re-organisation of services, found that 53% of participants were somewhat or very unhappy to have care co-located with O\&G services. Specifically, two key themes were identified through content analysis of free-text comments: "environment and getting this right is vital"; and "our cancer should be the priority".
However, via a BGCS survey, the investigator found that healthcare professionals (HCPs) underestimated strong patient preferences. Of those who see patients within O\&G services, only 50% said patients were seen at separate times/locations from obstetric patients. The investigators want to expand on these pilot data to better understand how to design services that better meet our patients' needs. The investigators will conduct a survey to ascertain service users' attitudes to location of services, collecting quantitative data \& qualitative data, including opportunities for feedback in free text. The investigator will conduct analysis using standard statistical methods \& content analysis of free-text responses. Submissions will be anonymous \& no identifiable data will be collected routinely, unless volunteered by the respondent. The investigator will ask a subset of ~30 participants to undertake a telephone/virtual-based semi-structured interview to further explore understanding on attitudes to location of care more generally. A topic guide will be developed, informed by the Theoretical Framework of Acceptability. Interviews will be audio-recorded with consent, transcribed verbatim \& anonymised. The anonymised transcripts will be analysed using a form of Thematic Analysis. These findings should help to shape future health care service sensitive to patient need.
- Conditions
- Gynecologic Cancers
What is being measured
The primary outcome is the main question the study is designed to answer.
Graceful 1
Patient-reported outcomes of acceptability of different clinic co-locations and the impact of different services.
Measured: 5 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 2025
- Study start24 Mar 2025
- Primary completion2 Feb 2029 (estimated)
- Study completion2 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancersStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Somerset NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06920342
- Sponsor's protocol ID
- 339158
- Acronym
- GRACEFUL
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2025
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating Attitudes to Gynaecological Rapid Access, Cancer Exclusion and Follow Up Location (GRACEFUL Study)
- ClinicalTrials.gov ID
- NCT06920342
- Acronym / sponsor ID
- GRACEFUL / 339158
- Conditions
- Gynecologic Cancers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Somerset NHS Foundation TrustUniversity, hospital or other
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 2 Feb 2029 (estimated)
- Study completion
- 2 Feb 2029 (estimated)
- First posted
- 9 Apr 2025 (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.
Gynaecological oncology (cancer) place of care is often based on evolution of services, along historical professional boundaries, rather than user needs or preferences. The investigators aim to gather views of patients in the United Kingdom (UK) on their preferred place of care for investigation, treatment and follow-up of gynaecological cancer. An initial scoping review found no previous work in this area. Pilot work, performed to inform local re-organisation of services, found that 53% of participants were somewhat or very unhappy to have care co-located with O\&G services. Specifically, two key themes were identified through content analysis of free-text comments: "environment and getting this right is vital"; and "our cancer should be the priority".
However, via a BGCS survey, the investigator found that healthcare professionals (HCPs) underestimated strong patient preferences. Of those who see patients within O\&G services, only 50% said patients were seen at separate times/locations from obstetric patients. The investigators want to expand on these pilot data to better understand how to design services that better meet our patients' needs. The investigators will conduct a survey to ascertain service users' attitudes to location of services, collecting quantitative data \& qualitative data, including opportunities for feedback in free text. The investigator will conduct analysis using standard statistical methods \& content analysis of free-text responses. Submissions will be anonymous \& no identifiable data will be collected routinely, unless volunteered by the respondent. The investigator will ask a subset of ~30 participants to undertake a telephone/virtual-based semi-structured interview to further explore understanding on attitudes to location of care more generally. A topic guide will be developed, informed by the Theoretical Framework of Acceptability. Interviews will be audio-recorded with consent, transcribed verbatim \& anonymised. The anonymised transcripts will be analysed using a form of Thematic Analysis. These findings should help to shape future health care service sensitive to patient need.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- UK
Key inclusion criteria (1 listed)
- Female Aged 18 or over Able to give informed consent Have been referred to secondary care with a suspected gynaecological cancer, or have previously been diagnosed with a gynaecological malignancy
Key exclusion criteria (1 listed)
- Male Unable to give informed consent
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
Graceful 1
Time frame: 5 years
Patient-reported outcomes of acceptability of different clinic co-locations and the impact of different services.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
- Individual participant dataSharing planned: No
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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.
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 Gynecologic Cancers, run by Somerset NHS Foundation Trust 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 1 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: looking for participants now, as of the sponsor's last update on 9 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Jo Morrison (+44 1823342562, jo.morrison@somersetft.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Graceful 1 (time frame: 5 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 9 Apr 2025.