CClinicalTrials.gg
CompletedNCT02829905WEM-QuantUpdated Jul 3, 2018

Women's Experiences of Mammography: Quantitative Evaluation

An observational study in Breast Cancer, sponsored by University of Dundee. Completed at 1 site in United Kingdom. Open to female participants aged 47 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-03.

Sponsored by University of Dundee · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
311
Ages
47 Years and older
Sex
Female
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Breast Cancer

Keywords

  • mass screening
  • patient satisfaction
  • radiography
  • mammography
03

In context

Lead sponsor

University of Dundee is the lead sponsor of 111 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
47 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Women eligible for population-based breast screening in the UK, i.e. aged 47+

Inclusion criteria

  • Eligible for NHS breast screening
  • Able to speak and write English.

Exclusion criteria

Exclusion Criteria:

  • Unable to provide informed consent
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
311 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Patient satisfaction with mammography experience

    11-point NRS

    Time frame: Immediate

Secondary outcomes

  1. Pain from mammography

    11-point NRS

    Time frame: Immediate

  2. Intention to re-attend for mammography screening

    11-point NRS

    Time frame: Immediate

07

Study locations

1 site
  • Ninewells Hospital
    Dundee, Scotland DD1 9SY, United Kingdom
08

References and documents

Individual participant data

Plan to share: Undecided — Applications considered on case by case basis.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02829905
Lead sponsor
University of Dundee
Collaborators
NHS Tayside, University of St Andrews
Responsible party
Patsy Whelehan (Senior Research Radiographer, University of Dundee) — Principal investigator
First posted
Jul 12, 2016
Start date
Nov 30, 2016
Primary completion
Jun 30, 2018
Completion
Jun 30, 2018
Last update
Jul 3, 2018

Study contacts

Patsy Whelehan, MSc
principal investigator · University of Dundee and NHS Tayside

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

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