Women's Experiences of Mammography: Quantitative Evaluation

Breast Cancer Clinical Trial

— WEM-Quant  

Official title:

Women's Experiences of Mammography: Quantitative Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829905
• Other study ID #: 2016ON15
• Status: Completed
• Start date: November 30, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2018
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Study will develop, validate and pilot measures to assess quality of experiences of mammography. Pilot data collection and analysis will investigate modifiable factors most important in determining quality of patient experiences of mammography.

Description:

While instruments to measure experiences of breast screening and mammography have been developed in the past, there is none which (a) concentrates in depth on the experience of the examination itself, (b) includes detailed breast positioning variables, (c) has been designed based on robust and transparent qualitative evidence, and (d) has been validated in a UK breast setting. Such a tool is needed to inform the design, development and testing of interventions to improve experiences of mammography. This is an important goal because many women are deterred from future breast screening by poor mammography experiences. Furthermore, regular client satisfaction surveys are required by the UK national breast screening programmes but there is no standard, validated measure in place.

The aim of this project is to develop, and obtain evidence for the validity of, a comprehensive toolkit of measures to evaluate experiences of mammography. The measures will be capable of assessing the quality of experiences of mammography and identifying modifiable predictors thereof. The investigators will pilot the measures in a sample of women attending for NHS breast screening. The resulting data will be used as the basis for building a statistical analysis model, for further validation of the measures, and for producing preliminary findings on what they are intended to measure.

Items generated from the investigators recent qualitative study will be combined with items from existing literature and with novel image-based metrics to draft comprehensive measures of women's mammography experiences. Questionnaires will capture 1. relevant modifiable potential determinants of overall quality of experience, such as the mammographer's ability to put the client at ease, 2. key potential confounding variables (e.g. client physical characteristics such as mobility problems or breast tenderness), and 3. outcome variables representing or postulated to contribute to overall quality of experience, including pain from the mammogram. Questionnaire development will follow established methods, including testing for face and content validity with a sample of field experts and of the target population, and checking for question design errors - such as leading questions - by a member of the team experienced in questionnaire construction. The draft questionnaires will be cognitively tested for understandability and acceptability with a small sample of women eligible for breast screening, and refined before administration to a larger sample of women attending for screening mammography. The questionnaire data will be incorporated into a statistical analysis model along with additional data which the investigators will extract from participants' mammographic images as follows.

The mammographic images will be examined for variables which may affect the client experience. These will include e.g. the compression force applied to the breast tissue during mammography, and features of the breast positioning technique. Thus, the measurement toolkit will have multiple parts. The investigators expect it to be capable of rigorous routine service and performance evaluation in mammography, of identifying what nature of interventions are needed to improve mammography experiences, and of evaluating the effectiveness of such interventions in the future.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 311
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 47 Years and older

Eligibility

Inclusion Criteria:

• Eligible for NHS breast screening

• Able to speak and write English.

Exclusion Criteria:

• Unable to provide informed consent

Related Conditions & MeSH terms

• Breast Cancer

Locations

Country	Name	City	State
United Kingdom	Ninewells Hospital	Dundee	Scotland

Sponsors (3)

Lead Sponsor	Collaborator
University of Dundee	NHS Tayside, University of St Andrews

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction with mammography experience	11-point NRS	Immediate
Secondary	Pain from mammography	11-point NRS	Immediate
Secondary	Intention to re-attend for mammography screening	11-point NRS	Immediate