Exploring Breast Referral Behaviours in Primary Care

NCT06701019 | Not Yet Recruiting

• 2 other identifiers: Sponsor ref 24068IRAS project ID: 334924
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Breast Cancer Female

Keywords

breast; qualitative; primary care; patient; female

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  From enrolment to data collection up to 3 months

Study Arms (1)

Data collection

OTHER

Semi-structured interview or focus group discussion.

Other: Semi-structured interview/focus group discussion

Interventions

Semi-structured interview/focus group discussion OTHER

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.

Data collection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Females who would need a language translator to take part in the study.

Sponsors & Collaborators

• University of Nottingham: lead
• National Institute for Health Research, United Kingdom: collaborator
• CoppaFeel: collaborator

Study Sites (1)

University of Nottingham

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Central Study Contacts

Beth J Richmond, PhD student

CONTACT

+447989785286; msxbr3@exmail.nottingham.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 18, 2024
• First Posted: November 22, 2024
• Study Start: May 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: December 31, 2025
• Last Updated: April 25, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)