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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • 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

    Recruiting

Other trials in United Kingdom

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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

  1. First posted9 Apr 2025
  2. Study start24 Mar 2025
  3. Primary completion2 Feb 2029 (estimated)
  4. Study completion2 Feb 2029 (estimated)

Resources

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)
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

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.

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