The Effect of Mirror Education for Women Undergoing Mastectomy
Primary Purpose
Emotional Distress, Anxiety, Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mirror Education
Sponsored by

About this trial
This is an interventional supportive care trial for Emotional Distress focused on measuring Mirror, Body Image, Mastectomy
Eligibility Criteria
Inclusion Criteria:
- Scheduled for breast cancer surgery
- Surgery to result in mastectomy where at least one entire breast is removed
- Speak, read, and understand English
Exclusion Criteria:
- 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).
Sites / Locations
- Memorial Hermann Healthcare System
- Texas Woman's University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Body Image/Mirror Education
Standard Care
Arm Description
Participants in the mirror arm will receive a mirror and mirror viewing education from oncology nurse navigators.
Patients 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Body image
Body image will be measured using the Body Image Scale (BIS).
Anxiety
Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS).
Depression
Depression will be measured using the HADS.
Use of mirrors
Use of mirrors will be measured using a structured questionnaire.
Full Information
NCT ID
NCT01642628
First Posted
July 12, 2012
Last Updated
March 28, 2014
Sponsor
Texas Woman's University
Collaborators
Memorial Hermann Health System, M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT01642628
Brief Title
The Effect of Mirror Education for Women Undergoing Mastectomy
Official Title
The Effect of Pre-Operative Education and Self-Reflection on Anxiety, Body Image, Depression and Emotional Well-Being of Women Undergoing Mastectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas Woman's University
Collaborators
Memorial Hermann Health System, M.D. Anderson Cancer Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The literature suggests women view the mastectomy site in a mirror post-operatively because they 1) are curious as to what their changed body looks like 2) need to do wound care and 3) want to keep up personal appearances. Regardless of the reason a women may choose to view self, viewing the post-operative site may be emotionally difficult. To confound the issue, the literature also suggests that there are few mirrors available in hospitals, clinics and physician offices. As such, women who have had a mastectomy may be unable to choose to view self in a mirror at any time, including during initial and/or subsequent dressing changes, with the support of a health care professional. The word mirror is seldom if ever discussed, and mirrors are seldom, if ever, offered to women who have had a mastectomy.
As such, 20 women will be recruited (ten in each group)by ONNs. ONNs will give potential participants the standardized description of the study and obtain consent. After participant randomization to either interventional or control groups, ONNs will give participants in the research group a handheld mirror and a handout on mirrors and mirror viewing. ONN's will review each element of the handout with the participants. ONN's will provide emotional support as appropriate for any participant who may have concerns, fears, or questions concerning the mirror. ONNs will also proceed with usual pre-operative education.
Participants in the control group will receive usual pre-operative education. Usual pre-operative education consists of a face-to-face pre-operative appointment with the ONN. The ONN provides education about the upcoming surgery, post-operative procedures, and breast cancer support resources.
Participants will be phoned post-operatively to set up a meeting one to three weeks post-operatively to re-administer the written instruments and, in addition, administer a written structured questionnaire on the subjects' use of the mirror.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emotional Distress, Anxiety, Depression
Keywords
Mirror, Body Image, Mastectomy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Body Image/Mirror Education
Arm Type
Experimental
Arm Description
Participants in the mirror arm will receive a mirror and mirror viewing education from oncology nurse navigators.
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
Patients 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.
Intervention Type
Other
Intervention Name(s)
Mirror Education
Other Intervention Name(s)
Experimental group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Emotional well-being
Description
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.
Time Frame
Change from pre-operative baseline up to three weeks post-operatively
Secondary Outcome Measure Information:
Title
Body image
Description
Body image will be measured using the Body Image Scale (BIS).
Time Frame
Change from pre-operative baseline up to three weeks post-operatively
Title
Anxiety
Description
Anxiety will be measured using the Hospital Anxiety and Depression Scale (HADS).
Time Frame
Change from pre-operative baseline up to three weeks post-operatively
Title
Depression
Description
Depression will be measured using the HADS.
Time Frame
Change from pre-operative baseline up to three weeks post-operatively
Title
Use of mirrors
Description
Use of mirrors will be measured using a structured questionnaire.
Time Frame
Up to three weeks post-operatively
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled for breast cancer surgery
Surgery to result in mastectomy where at least one entire breast is removed
Speak, read, and understand English
Exclusion Criteria:
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wyona M. Freysteinson, PhD, MN
Organizational Affiliation
Texas Woman's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial Hermann Healthcare System
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Texas Woman's University
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
22750894
Citation
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.
Results Reference
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The Effect of Mirror Education for Women Undergoing Mastectomy
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