Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of an Educational Intervention for Women With Breast Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03936842
Recruitment Status : Not yet recruiting
First Posted : May 3, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

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

  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

Condition or disease Intervention/treatment Phase
Breast Pain Mastalgia Behavioral: Breast Pain video Behavioral: Semi-structure interviews Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of an Educational Intervention for Women With Breast Pain
Estimated Study Start Date : May 31, 2019
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Arm Intervention/treatment
Experimental: Single Arm
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
An educational video of approximately 10 minutes about breast pain, self-examination and breast awareness will be shown to the participant.

Behavioral: Semi-structure interviews
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.




Primary Outcome Measures :
  1. Patient's perceptions on the breast-pain video [ Time Frame: 10 minutes ]
    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.


Secondary Outcome Measures :
  1. Video's purpose evaluation [ Time Frame: 10 minutes ]

    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03936842


Contacts
Layout table for location contacts
Contact: Ann Gandolfi 02086613903 ann.gandolfi@rmh.nhs.uk
Contact: Jennifer Rusby, consultant 07957648248 Jennifer.Rusby@rmh.nhs.uk

Locations
Layout table for location information
United Kingdom
Royal Marsden Hospital NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Additional Information:
Publications:
Ader DN, Shriver CD. Update on clinical and research issues in cyclical mastalgia. Breast J 1998;4:25-32.

Layout table for additonal information
Responsible Party: Royal Marsden NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03936842    
Other Study ID Numbers: CCR5063
First Posted: May 3, 2019    Key Record Dates
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Mastodynia
Pain
Neurologic Manifestations
Signs and Symptoms