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Breast PainNCT03936842

Evaluation of an Educational Intervention for Women With Breast Pain

A study testing Breast Pain video and Semi-structure interviews in people with Breast Pain and Mastalgia, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Evaluation of an educational intervention for women with breast pain Target Problem -Symptomatic breast pain Study Objectives- The primary objective is to obtain knowledge of women's perceptions of an educational video about breast pain, breast awareness and self-examination and its impact on their confidence in… Read more about this study

Who is it for?
Ages 18 to 40 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Pain, Mastalgia
What is being tested?
Breast Pain video and Semi-structure interviews
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited Kingdom
Study dates
31 May 2019to 30 Sep 2019
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 to 40 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy female patients aged between 18 years and 40 years on the day of clinic attendance (referred to one-stop breast clinic with breast pain alone)
  • Normal examination in clinic
  • No further breast investigations undertaken or required

Who cannot join

  • Presence of concerning features during clinical examination requiring further investigation
  • Pregnancy or lactation at the time of study diagnosis.
  • Strong family history of breast cancer
  • Recent previous imaging or clinic attendance for same symptom within last 12 months
  • Previous history of breast cancer
  • Current or previous treatment with Tamoxifen
  • Medical or psychiatric illness which, in the opinion of the assessing clinician, might impact their participation in the study

Trial locations and contacts

1 site in 1 country.

Jennifer Rusby, consultant contact

07957648248

Jennifer.Rusby@rmh.nhs.uk

United Kingdom1 site
  • Royal Marsden Hospital NHS Foundation Trust

    London, SW3 6JJ

Other trials in United Kingdom

About this study

Evaluation of an educational intervention for women with breast pain

Target Problem -Symptomatic breast pain Study Objectives- The primary objective is to obtain knowledge of women's perceptions of an educational video about breast pain, breast awareness and self-examination and its impact on their confidence in self-management of breast pain.

Read more

The secondary objectives -proportion of women who report that the video

  1. Was informative
  2. Might have reassured them enough not to have needed to seek an appointment in secondary care.

Study Design- Prospective single-centre mixed methods study through semi-structured interviews for Masters in Public Health thesis Trial Population -Women, aged 18-40, referred to "one-stop" / rapid diagnostic breast clinic at The Royal Marsden Hospital (RMH) with breast pain alone.

Recruitment target Until saturation, expected sample 10-15 Trial Design- Mixed methods study using semi-structured interviews Primary endpoint -This is a qualitative study, with no statistical primary end point.

Secondary endpoints-Descriptive summaries of two questions will be reported as a secondary end point.

Inclusion Criteria

  • Women aged between 18 years and 40 years on the day of clinic attendance
  • Breast pain as the only symptom
  • Normal clinical examination
  • No further investigation (imaging, biopsy etc) Exclusion Criteria
  • Presence of suspicious features during clinical examination requiring further investigation
  • Strong family history of breast cancer
  • Previous breast imaging within last 12 months
  • Previous history of breast cancer
  • Current or previous treatment with Tamoxifen
  • Concurrent cancer
  • Medical or psychiatric illness which might impact their participation in the study
Read the detailed description

The prevalence of breast pain has been reported to be between 41-69% in clinical cohorts and in the general population (1-4). The incidence of cancer in women with breast pain alone (ie no lump or other, more concerning symptoms) is low, with published rates between 1 to 1.8% (7-9).

Furthermore, the prevalence of breast pain increases linearly up to the age of 50 and then decreases (4), thus women under 40 with a normal clinical examination do not require further investigations and can be reassured in primary care.

Despite this, mastalgia is one of the most common symptoms in women referred to a breast unit representing up to 69% of attendances (5-7). Consequently, women affected by breast pain are up to 4.7 times more likely to have had a mammogram than asymptomatic women (6). ln order to facilitate early breast cancer diagnosis there is a suspected cancer pathway referral (for an appointment within 2 weeks) from primary care to specialist units. Recent increases in breast urgent referrals have increased the pressure on already overstretched services.

Many strategies have been tried to manage the tension between the desire for early detection of breast cancer, and avoiding unnecessary referral for normal breast sensations.

Although breast screening by self-examination or clinical examination has not been shown to reduce breast cancer mortality in studies (10), breast awareness can be linked to early detection that facilitates treatment and has the potential to reduce mortality (11). Therefore, breast awareness and self-examination have become relevant parts of general breast education promoting women's confidence to discern between normality and unusual changes (12-17). Self-examination is not frequently taught in primary care and "there is a need to develop more innovative strategies to promote breast health awareness and early detection of breast cancer in women" (18). In this study, as part of a Masters in Health Policy, we are investigating the impact of an educational video, here to be shown after a clinic appointment, but with the potential to be distributed to general practitioners, and to patients directly if favourably received.

Methodology

  1. Patient recruitment 1.1 Initial visit to "one-stop"clinic Eligible patients who are referred to the "one-stop" diagnostic clinic with breast pain alone and have completed a clinical assessment will be given a patient information sheet inviting them to participate in the study. They will be met by the interviewing clinician at the same visit. 1.2 Consent Consent will be sought by the clinician who will undertake the interviews.
  2. Intervention: educational video An educational video of approximately 10 minutes about breast pain, self-examination and breast awareness will be shown to the participant.
  3. Semi-structured interview A semi-structured, face-to-face interview will be then undertaken. The principles of Grounded Theory will be used to guide the interview. All of the interviews will be recorded and transcribed securely, only referencing the patient according to their study number. Their name and hospital number will not be used.

A number of pre-planned, open questions will be asked. The core questions are related to the topic of discussion - impressions related to the intervention and subsequent effect into their previous concerns. Further questions will evolve in response to answers given by earlier participants. The duration of the interview will depend on the extent of the answers and any follow-up questions that derive later from earlier answers.

Data Acquisition and analysis The video show and interview will be undertaken in a private room after routine clinical assessment. The interviewer will be the MSc student, a medically-qualified breast clinician with an interest in breast pain, who has read the relevant literature. The recorded interview and notes taken by investigator during the interview are the only data.

The analysis will run alongside data collection as an iterative process to inform further sampling. The purpose of the analysis is to describe the participants' opinion and to develop theoretical explanations for these. The interviews will be analysed by reading the transcripts in detail and assigning codes to give meaning to segments of the text. Emerging codes will be grouped into themes and discussed and then explored in subsequent interviews. The analysis will be undertaken using the constant comparison technique of grounded theory whereby data will be examined for differences and similarities within the themes, taking into account the patient context. The initial codes will be modified and new codes added as the project progresses. New data will be compared with previous interviews to identify the similarities and differences.

Evaluation of Outcome This is a mixed methods study. As a result, we will have increased knowledge of the perceptions of women presenting with breast pain about an educational video. We will have some quantitative information about whether they find it informative and whether it might lead them to avoid attending secondary care. It will guide the future management of women with pain at the interface of primary and secondary care.

Being tested
Breast Pain video, Semi-structure interviews
Medical subject headings
Mastodynia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breast Pain videoBehavioural

    An educational video of approximately 10 minutes about breast pain, self-examination and breast awareness will be shown to the participant.

  • Semi-structure interviewsBehavioural

    A semi-structured, face-to-face interview will be then undertaken. The principles of Grounded Theory will be used to guide the interview. All of the interviews will be recorded and transcribed securely, only referencing the patient according to their study number. Their name and hospital number will not be used.

Study groups in NCT03936842
Study groupRoleWhat they receive
Single ArmExperimentalEligible patients who are referred to the "one-stop" diagnostic clinic with breast pain alone and have completed a clinical assessment will be given a patient information sheet inviting them to participate in the study. They will be met by the interviewing clinician at the same visit.
Receives: Behavioral: Breast Pain video; Behavioral: Semi-structure interviews

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient's perceptions on the breast-pain video

    Due to the semi-structure interview qualitative nature of the study the primary objective is to obtain observational data for insights and patterns (through "quotes") of women's perceptions of an educational video about breast pain, breast awareness and self-examination and its impact on their confidence in self-management of breast pain.

    Measured: 10 minutes

Secondary outcomes (1)
  1. Video's purpose evaluation

    proportion of women who report that the video

    1. Was informative
    2. Might have reassured them enough not to have needed to seek an appointment in secondary care

    Measured: 10 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 May 2019
  2. Study start31 May 2019 (estimated)
  3. Primary completion31 Jul 2019 (estimated)
  4. Study completion30 Sep 2019 (estimated)

Resources

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
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03936842
Sponsor's protocol ID
CCR5063
Status last verified
May 2019
First submitted
18 Apr 2019
Last updated
3 May 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ader DN, Shriver CD. Update on clinical and research issues in cyclical mastalgia. Breast J 1998;4:25-32.

  • Boyle CA, Berkowitz GS, Kelsey JL. Epidemiology of premenstrual symptoms. Am J Public Health. 1987 Mar;77(3):349-50. doi: 10.2105/ajph.77.3.349.

    PubMed 3812845
  • Smith RL, Pruthi S, Fitzpatrick LA. Evaluation and management of breast pain. Mayo Clin Proc. 2004 Mar;79(3):353-72. doi: 10.4065/79.3.353.

    PubMed 15008609
  • Scurr J, Hedger W, Morris P, Brown N. The prevalence, severity, and impact of breast pain in the general population. Breast J. 2014 Sep-Oct;20(5):508-13. doi: 10.1111/tbj.12305. Epub 2014 Jul 7.

    PubMed 25041468
  • Newton P, Hannay DR, Laver R. The presentation and management of female breast symptoms in general practice in Sheffield. Fam Pract. 1999 Aug;16(4):360-5. doi: 10.1093/fampra/16.4.360.

    PubMed 10493705
  • Ader DN, Browne MW. Prevalence and impact of cyclic mastalgia in a United States clinic-based sample. Am J Obstet Gynecol. 1997 Jul;177(1):126-32. doi: 10.1016/s0002-9378(97)70450-2.

    PubMed 9240595
  • Barton MB, Elmore JG, Fletcher SW. Breast symptoms among women enrolled in a health maintenance organization: frequency, evaluation, and outcome. Ann Intern Med. 1999 Apr 20;130(8):651-7. doi: 10.7326/0003-4819-130-8-199904200-00005.

    PubMed 10215561
  • Eberl MM, Phillips RL Jr, Lamberts H, Okkes I, Mahoney MC. Characterizing breast symptoms in family practice. Ann Fam Med. 2008 Nov-Dec;6(6):528-33. doi: 10.1370/afm.905.

    PubMed 19001305
  • Joyce DP, Alamiri J, Lowery AJ, Downey E, Ahmed A, McLaughlin R, Hill AD. Breast clinic referrals: can mastalgia be managed in primary care? Ir J Med Sci. 2014 Dec;183(4):639-42. doi: 10.1007/s11845-013-1066-z. Epub 2014 Jan 9.

    PubMed 24402166
  • Kosters JP, Gotzsche PC. Regular self-examination or clinical examination for early detection of breast cancer. Cochrane Database Syst Rev. 2003;2003(2):CD003373. doi: 10.1002/14651858.CD003373.

    PubMed 12804462
  • Richards MA. The National Awareness and Early Diagnosis Initiative in England: assembling the evidence. Br J Cancer. 2009 Dec 3;101 Suppl 2(Suppl 2):S1-4. doi: 10.1038/sj.bjc.6605382.

    PubMed 19956152
  • Mac Bride MB, Pruthi S, Bevers T. The evolution of breast self-examination to breast awareness. Breast J. 2012 Nov-Dec;18(6):641-3. doi: 10.1111/tbj.12023. Epub 2012 Sep 26. No abstract available.

    PubMed 23009674
  • Byrne S, Robles-Rodriguez E. Educational parties as a strategy to promote breast health awareness and screening in underserved female populations. Oncol Nurs Forum. 2009 Mar;36(2):145-8. doi: 10.1188/09.ONF.145-148. No abstract available.

    PubMed 19273403

Questions about this trial

What is this clinical trial studying?

A study testing Breast Pain video and Semi-structure interviews in people with Breast Pain and Mastalgia, run by Royal Marsden NHS Foundation Trust 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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 May 2019. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ann Gandolfi (02086613903, ann.gandolfi@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient's perceptions on the breast-pain video (time frame: 10 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03936842, which also lists 13 linked publications.

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 May 2019.

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