Breast Cancer FemaleNCT06701019
Exploring Breast Referral Behaviours in Primary Care
A study testing Semi-structured interview/focus group discussion in people with Breast Cancer Female, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
The study will explore the experiences of women going to see their GP with breast-related health concerns and will involve finding out more about factors which may help and hinder them getting referred to a specialist for suspected breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Semi-structured interview/focus group discussion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 May 2025to 31 Jan 2026
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cisgender females (assigned to the female sex at birth)
- Aged 18 years and over (no upper age limit)
- Have/had breast-related health concerns regardless of breast cancer diagnosis
- Have presented their symptoms initially in a primary care setting rather than having been alerted to potential issues during routine breast screening
- Been referred from primary care within the previous year
- Be using the NHS healthcare system in either England or Wales.
Who cannot join
- Females who would need a language translator to take part in the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Nottingham
Nottingham, Nottinghamshire, NG5 1PB
About this study
Official title: Exploring and Understanding Female Breast Health Referral Behavours in Primary Care: A Qualitative Interview/Focus Group Study
The study will explore the experiences of women going to see their GP with breast-related health concerns and will involve finding out more about factors which may help and hinder them getting referred to a specialist for suspected breast cancer. As well as considering implications for further research, the study aims to inform clinical practice in terms of potential improvements to related medical education and the development of tools that could be introduced/refined for enhancing GP referrals in this area.
Breast cancer is the most diagnosed cancer amongst UK women, with incidence rates increasing by around a quarter since the early 1990s. It accounts for 30% of all female diagnosed cancers and causes around 11,500 deaths in the UK annually. Early detection is key as stage at diagnosis is the most important predictor of health outcome and most cancers are diagnosed after symptomatic patients see their GP. This highlights the pivotal role of primary care with managing breast-related abnormalities in a timely and appropriate manner. Little is currently known about the research area, particularly from a qualitative standpoint.
Read more
Adult females who have been referred to secondary care by their GP because of a breast health concern will be eligible to take part in the study. Participants will mainly be recruited through the Nottingham Breast Institute, East Midlands GP surgeries, and the study funder's digital/online influencer channels. Participants will be involved in semi-structured interviews or focus groups, with the data collection phase expected to take around six months. The study is funded by breast health awareness charity, Coppafeel!.
The findings of a systematic review and analysis of breast cancer-related online support group messages, focusing on the experiences relating to women seeing their GP with breast-health issues (also being undertaken by the researcher), will also be used to triangulate and inform study findings.
Read the detailed description
Exploratory, cross-sectional, retrospective semi-structured interview and focus group study across multi-centres.
Objectives:
- To find out about the factors women perceive as those which hindered and/or facilitated participants' referral to a breast clinic for further investigation, and how and why the female patients believe these occurred.
- To look at improvements/changes the participants believe could be implemented to improve the related management of their health, particularly from a medical education perspective.
Settings:
Interviews/focus groups will be held online wherever possible using the following to reach potential participants:
- New referral clinics at the Nottingham Breast Institute at Nottingham City Hospital
- NIHR 'research initiative site' GP practices across the East Midlands which elect to get involved as participant identification centres; and
- The funder's (CoppaFeel!) digital communications channels and those of its ambassadors/social media influencers to reach potential participants.
Number of participants:
Up to 40 participants may be recruited but the concept of information power will be used to inform actual sample size. The participants will be women who have been to see their GP with breast-related health issues/symptoms.
Interventions:
- Requesting responses to related medical history/status and demographic questions in advance of the related substantive interview or focus group discussion (once per participant) - approx. 30 mins
- One online semi-structured interview or focus group discussion per participant - approx. 1 hour.
Duration of study:
- Overall: six months (to start soon as all necessary approvals are in place)
- Per participant: up to three months.
Method of analysis:
Data collected will be examined using inductive thematic analysis. This analytical approach allows themes, patterns and meanings to be generated from the data, and in the process, help identify factors which participants perceive as helping or hindering their breast referral to secondary care among patients and primary care healthcare professionals; and why, and how, these occurred.
- Conditions
- Breast Cancer Female
- Being tested
- Semi-structured interview/focus group discussion
- Keywords
- breast, qualitative, primary care, patient, female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semi-structured interview/focus group discussionOther
All participants will be asked via email for their medical history/status and demographic information.
Participants will either be involved in online semi-structured interview or focus group discussion (FGD). Note: they may allocated to a FGD where they share common characteristics with other participants (eg, they are younger women or presented at their GP practice with non-lump symptoms). However, if the participants prefer to be interviewed instead, the student will accommodate this option.
| Study group | Role | What they receive |
|---|---|---|
| Data collection | Other | Semi-structured interview or focus group discussion. Receives: Other: Semi-structured interview/focus group discussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barriers and facilitators to referral measured via data collected from a semi-structured interview or focus group discussion with up to 40 participants
The factors women perceive as those which hindered and/or facilitated participants' referral to a breast clinic for further investigation, and how and why the female patients believe these occurred.
Measured: From enrolment to data collection up to 3 months
Secondary outcomes (1)
Suggested health management improvements measured via data collected from a semi-structured interview or focus group discussion with up to 40 participants
Improvements/changes the participants believe could be implemented to improve the related management of their health, particularly from a medical education perspective.
Measured: From enrolment to data collection up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start1 May 2025
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be asked via email for their medical history/status and demographic information. Participants will either be involved in an online semi-structured interview or focus group discussion (FGD). Note: they may allocated to a FGD where they share common characteristics with other participants (eg, they are younger women or presented at their GP practice with non-lump symptoms). However, if the participants prefer to be interviewed instead, the student will accommodate this option.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, CoppaFeel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701019
- Sponsor's protocol ID
- Sponsor ref 24068
- Other IDs
- IRAS project ID: 334924
- Status last verified
- Nov 2024
- First submitted
- 18 Nov 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To comply with the Data Protection Act, personal data will be deleted as soon as possible after it is no longer needed for the study and at the latest by six months of the end of the study. However, if participants agree, their contact details will be kept so as to send them the findings of the study and to contact them about participating in future research studies.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring and Understanding Female Breast Health Referral Behavours in Primary Care: A Qualitative Interview/Focus Group Study
- ClinicalTrials.gov ID
- NCT06701019
- Acronym / sponsor ID
- Sponsor ref 24068
- Conditions
- Breast Cancer Female
- Keywords
- breast, qualitative, primary care, patient, female
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- National Institute for Health Research, United Kingdom, CoppaFeel
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 22 Nov 2024 (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.
The study will explore the experiences of women going to see their GP with breast-related health concerns and will involve finding out more about factors which may help and hinder them getting referred to a specialist for suspected breast cancer. As well as considering implications for further research, the study aims to inform clinical practice in terms of potential improvements to related medical education and the development of tools that could be introduced/refined for enhancing GP referrals in this area.
Breast cancer is the most diagnosed cancer amongst UK women, with incidence rates increasing by around a quarter since the early 1990s. It accounts for 30% of all female diagnosed cancers and causes around 11,500 deaths in the UK annually. Early detection is key as stage at diagnosis is the most important predictor of health outcome and most cancers are diagnosed after symptomatic patients see their GP. This highlights the pivotal role of primary care with managing breast-related abnormalities in a timely and appropriate manner. Little is currently known about the research area, particularly from a qualitative standpoint.
Adult females who have been referred to secondary care by their GP because of a breast health concern will be eligible to take part in the study. Participants will mainly be recruited through the Nottingham Breast Institute, East Midlands GP surgeries, and the study funder's digital/online influencer channels. Participants will be involved in semi-structured interviews or focus groups, with the data collection phase expected to take around six months. The study is funded by breast health awareness charity, Coppafeel!.
The findings of a systematic review and analysis of breast cancer-related online support group messages, focusing on the experiences relating to women seeing their GP with breast-health issues (also being undertaken by the researcher), will also be used to triangulate and inform study findings.
Detailed description
Exploratory, cross-sectional, retrospective semi-structured interview and focus group study across multi-centres.
Objectives:
- To find out about the factors women perceive as those which hindered and/or facilitated participants' referral to a breast clinic for further investigation, and how and why the female patients believe these occurred.
- To look at improvements/changes the participants believe could be implemented to improve the related management of their health, particularly from a medical education perspective.
Settings:
Interviews/focus groups will be held online wherever possible using the following to reach potential participants:
- New referral clinics at the Nottingham Breast Institute at Nottingham City Hospital
- NIHR 'research initiative site' GP practices across the East Midlands which elect to get involved as participant identification centres; and
- The funder's (CoppaFeel!) digital communications channels and those of its ambassadors/social media influencers to reach potential participants.
Number of participants:
Up to 40 participants may be recruited but the concept of information power will be used to inform actual sample size. The participants will be women who have been to see their GP with breast-related health issues/symptoms.
Interventions:
- Requesting responses to related medical history/status and demographic questions in advance of the related substantive interview or focus group discussion (once per participant) - approx. 30 mins
- One online semi-structured interview or focus group discussion per participant - approx. 1 hour.
Duration of study:
- Overall: six months (to start soon as all necessary approvals are in place)
- Per participant: up to three months.
Method of analysis:
Data collected will be examined using inductive thematic analysis. This analytical approach allows themes, patterns and meanings to be generated from the data, and in the process, help identify factors which participants perceive as helping or hindering their breast referral to secondary care among patients and primary care healthcare professionals; and why, and how, these occurred.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be asked via email for their medical history/status and demographic information. Participants will either be involved in an online semi-structured interview or focus group discussion (FGD). Note: they may allocated to a FGD where they share common characteristics with other participants (eg, they are younger women or presented at their GP practice with non-lump symptoms). However, if the participants prefer to be interviewed instead, the student will accommodate this option.
| Arm | Type | Receives |
|---|---|---|
| Data collection | Other | Other: Semi-structured interview/focus group discussionSemi-structured interview or focus group discussion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Cisgender females (assigned to the female sex at birth)
- Aged 18 years and over (no upper age limit)
- Have/had breast-related health concerns regardless of breast cancer diagnosis
- Have presented their symptoms initially in a primary care setting rather than having been alerted to potential issues during routine breast screening
- Been referred from primary care within the previous year
Key exclusion criteria (1 listed)
- Females who would need a language translator to take part in the study.
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 |
|---|---|---|
| Semi-structured interview/focus group discussionAll participants will be asked via email for their medical history/status and demographic information. Participants will either be involved in online semi-structured interview or focus group discussion (FGD). Note: they may allocated to a FGD where they share common characteristics with other participants (eg, they are younger women or presented at their GP practice with non-lump symptoms). However, if the participants prefer to be interviewed instead, the student will accommodate this option. | Other | Data collection |
Primary outcome
Barriers and facilitators to referral measured via data collected from a semi-structured interview or focus group discussion with up to 40 participants
Time frame: From enrolment to data collection up to 3 months
The factors women perceive as those which hindered and/or facilitated participants' referral to a breast clinic for further investigation, and how and why the female patients believe these occurred.
1 secondary outcome
Suggested health management improvements measured via data collected from a semi-structured interview or focus group discussion with up to 40 participants
Time frame: From enrolment to data collection up to 3 months
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 27 Jul 2026.
- Individual participant dataSharing planned: No. To comply with the Data Protection Act, personal data will be deleted as soon as possible after it is no longer needed for the study and at the latest by six months of the end of the study. However, if participants agree, their contact details will be kept so as to send them the findings of the study and to contact them about participating in future research studies.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semi-structured interview/focus group discussion in people with Breast Cancer Female, run by University of Nottingham 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 6 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: finished, as of the sponsor's last update on 27 Jul 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?
Barriers and facilitators to referral measured via data collected from a semi-structured interview or focus group discussion with up to 40 participants (time frame: From enrolment to data collection up to 3 months). 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 27 Jul 2026.