Breast Pain Clinical Trial
Official title:
Evaluation of an Educational Intervention for Women With Breast Pain
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.
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
Status | Not yet recruiting |
Enrollment | 15 |
Est. completion date | September 30, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Marsden Hospital NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust |
United Kingdom,
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. — View Citation
Ader DN, Shriver CD. Update on clinical and research issues in cyclical mastalgia. Breast J 1998;4:25-32.
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. — View Citation
Boyle CA, Berkowitz GS, Kelsey JL. Epidemiology of premenstrual symptoms. Am J Public Health. 1987 Mar;77(3):349-50. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Kösters JP, Gøtzsche PC. Regular self-examination or clinical examination for early detection of breast cancer. Cochrane Database Syst Rev. 2003;(2):CD003373. Review. — View Citation
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. — View Citation
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. — View Citation
Richards MA. The National Awareness and Early Diagnosis Initiative in England: assembling the evidence. Br J Cancer. 2009 Dec 3;101 Suppl 2:S1-4. doi: 10.1038/sj.bjc.6605382. — View Citation
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. — View Citation
Smith RL, Pruthi S, Fitzpatrick LA. Evaluation and management of breast pain. Mayo Clin Proc. 2004 Mar;79(3):353-72. Review. — View Citation
* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 10 minutes | |
Secondary | Video's purpose evaluation | proportion of women who report that the video Was informative Might have reassured them enough not to have needed to seek an appointment in secondary care |
10 minutes |
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