Evaluation of an Educational Intervention for Women With Breast Pain

NCT03936842 | Unknown

• 1 other identifier: CCR5063
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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 self-management of breast pain. The secondary objectives -proportion of women who report that the video

• 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

Conditions

Breast Pain; Mastalgia

Outcome Measures

Primary Outcomes (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.

  10 minutes

Secondary Outcomes (1)

• Video's purpose evaluation

  10 minutes

Study Arms (1)

Single Arm

EXPERIMENTAL

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.

Behavioral: Breast Pain video; Behavioral: Semi-structure interviews

Interventions

Breast Pain video BEHAVIORAL

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

Single Arm

Semi-structure interviews BEHAVIORAL

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.

Single Arm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden Hospital NHS Foundation Trust

London, SW3 6JJ, United Kingdom

Location

Related Publications (13)

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

  BACKGROUND

• 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.

  PMID: 3812845 BACKGROUND

• 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.

  PMID: 15008609 BACKGROUND

• 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.

  PMID: 25041468 BACKGROUND

• 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.

  PMID: 10493705 BACKGROUND

• 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.

  PMID: 9240595 BACKGROUND

• 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.

  PMID: 10215561 BACKGROUND

• 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.

  PMID: 19001305 BACKGROUND

• 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.

  PMID: 24402166 BACKGROUND

• 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.

  PMID: 12804462 BACKGROUND

• 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.

  PMID: 19956152 BACKGROUND

• 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.

  PMID: 23009674 BACKGROUND

• 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.

  PMID: 19273403 BACKGROUND

Related Links

• National Institute for Health and Clinical Excellence (NICE). Familial Breast Cancer: Full Guideline.
• International Agency for Research on Cancer (IARC). IARC Screening Group.
• National Office of NHS Cancer Screening Programmes, Public Health England. NHS Breast Cancer Screening Programme 2013

MeSH Terms

Conditions

Mastodynia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Ann Gandolfi

CONTACT

02086613903; ann.gandolfi@rmh.nhs.uk

Jennifer Rusby, consultant

CONTACT

07957648248; Jennifer.Rusby@rmh.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: May 3, 2019
• Study Start: May 31, 2019
• Primary Completion: July 31, 2019
• Study Completion: September 30, 2019
• Last Updated: May 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)