Breast CancerWEM-QuantNCT02829905
Women's Experiences of Mammography: Quantitative Evaluation
An observational study of Breast Cancer, run by University of Dundee at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 47 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 311 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 30 Nov 2016to 30 Jun 2018
- Phase
- Observational
- 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 47 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women eligible for population-based breast screening in the UK, i.e. aged 47+
Who may be able to join
- Eligible for NHS breast screening
- Able to speak and write English.
Who cannot join
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Breast Cancer
- Keywords
- mass screening, patient satisfaction, radiography, mammography
- Medical subject headings
- Breast Neoplasms, Patient Satisfaction
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction with mammography experience
11-point NRS
Measured: Immediate
Secondary outcomes (2)
Pain from mammography
11-point NRS
Measured: Immediate
Intention to re-attend for mammography screening
11-point NRS
Measured: Immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start30 Nov 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Tayside, University of St Andrews
- Responsible party
- Principal investigator, Patsy Whelehan, University of Dundee
- Investigators
- Patsy Whelehan, MSc, Principal investigator, University of Dundee and NHS Tayside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829905
- Sponsor's protocol ID
- 2016ON15
- Acronym
- WEM-Quant
- Status last verified
- Jul 2018
- First submitted
- 8 Jul 2016
- Last updated
- 3 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided: Applications considered on case by case basis.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Women's Experiences of Mammography: Quantitative Evaluation
- ClinicalTrials.gov ID
- NCT02829905
- Acronym / sponsor ID
- WEM-Quant / 2016ON15
- Conditions
- Breast Cancer
- Keywords
- mass screening, patient satisfaction, radiography, mammography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Collaborators
- NHS Tayside, University of St Andrews
- Study start
- 30 Nov 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 12 Jul 2016 (estimated)
- 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.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 47 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women eligible for population-based breast screening in the UK, i.e. aged 47+
Key inclusion criteria (2 listed)
- Eligible for NHS breast screening
- Able to speak and write English.
Key exclusion criteria (1 listed)
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient satisfaction with mammography experience
Time frame: Immediate
11-point NRS
2 secondary outcomes
Pain from mammography
Time frame: Immediate
Intention to re-attend for mammography screening
Time frame: Immediate
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 3 Jul 2018.
- Individual participant dataSharing planned: Undecided. Applications considered on case by case basis.
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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.
Patsy Whelehan, MSc principal investigator
University of Dundee and NHS Tayside
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of Dundee 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 2 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 3 Jul 2018. 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?
Patient satisfaction with mammography experience (time frame: Immediate). 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 3 Jul 2018.