The Effect of Mirror Education for Women Undergoing Mastectomy
The Effect of Pre-Operative Education and Self-Reflection on Anxiety, Body Image, Depression and Emotional Well-Being of Women Undergoing Mastectomy
1 other identifier
interventional
19
1 country
2
Brief Summary
Intuitively, the investigators surmise the initial and subsequent viewing of a breast site following mastectomy may be traumatic. A qualitative study on the experience of viewing self in the mirror for a woman who has had a mastectomy has confirmed the experience is unique for each individual, and may well be difficult. This research study aims to determine if these difficult moments may be buffered by a mirror intervention providing women who are scheduled for a mastectomy with a hand held mirror, instructions by a Oncology Nurse Navigator (ONN) on how to use the mirror in initial and subsequent dressing changes, and offering to discuss any concerns or questions. The purpose of this study is to evaluate the feasibility of a nursing mirror educational intervention and determine if it is of potential value for women scheduled for a mastectomy. Results from this pilot study will help determine whether the research design, setting, sample, instruments, data collection and data analysis are appropriate and practical for a larger study. Hypothesis Women, ages 18 and over, who have had a mastectomy, and receive a planned pre-operative education and self-reflection intervention will have relatively improved anxiety, body image, depression and emotional well-being scores one to three weeks post-operatively as compared to those who received usual care.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2012
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2012
CompletedFirst Posted
Study publicly available on registry
July 17, 2012
CompletedStudy Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedApril 1, 2014
March 1, 2014
1.3 years
July 12, 2012
March 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Emotional well-being
Emotional well-being will be measured using MOS 36-Item Short Form Survey (SF-36) emotional well-being subscale and Functional Assessment of Cancer Therapies (FACT) emotional well-being scale.
Change from pre-operative baseline up to three weeks post-operatively
Secondary Outcomes (4)
Body image
Change from pre-operative baseline up to three weeks post-operatively
Anxiety
Change from pre-operative baseline up to three weeks post-operatively
Depression
Change from pre-operative baseline up to three weeks post-operatively
Use of mirrors
Up to three weeks post-operatively
Study Arms (2)
Body Image/Mirror Education
EXPERIMENTALParticipants in the mirror arm will receive a mirror and mirror viewing education from oncology nurse navigators.
Standard Care
NO INTERVENTIONPatients allocated to the control group will receive the usual pre and post-op standard care that does not include the use or discussion of mirrors.
Interventions
Patients allocated to the experimental group will be given a small hand-held mirror and structured mirror viewing education verbally. In addition, they will receive a mirror viewing handout. This intervention will be given prior to mastectomy surgery. In addition, participants will receive all other standard care.
Eligibility Criteria
You may qualify if:
- Scheduled for breast cancer surgery
- Surgery to result in mastectomy where at least one entire breast is removed
- Speak, read, and understand English
You may not qualify if:
- Patients having a guardian that is responsible for medical decisions.
- Patients reporting a diagnosis of body dysmorphic disorder
- Patients who have undergone previous breast cancer surgery
- Patients undergoing breast reconstruction other than placement of implant(s)or tissue expander(s).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Texas Woman's Universitylead
- Memorial Hermann Health Systemcollaborator
- M.D. Anderson Cancer Centercollaborator
Study Sites (2)
Memorial Hermann Healthcare System
Houston, Texas, 77024, United States
Texas Woman's University
Houston, Texas, 77030, United States
Related Publications (1)
Freysteinson WM, Deutsch AS, Lewis C, Sisk A, Wuest L, Cesario SK. The experience of viewing oneself in the mirror after a mastectomy. Oncol Nurs Forum. 2012 Jul;39(4):361-9. doi: 10.1188/12.ONF.361-369.
PMID: 22750894BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wyona M. Freysteinson, PhD, MN
Texas Woman's University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 12, 2012
First Posted
July 17, 2012
Study Start
August 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 1, 2014
Record last verified: 2014-03