Clinical trial NCT01642628: 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
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Distress
Anxiety
Depression
Keywords: Mirror
Body Image
Mastectomy
Lead sponsor: Texas Woman's University
Sponsor class: OTHER
Collaborators: name: Memorial Hermann Health System
name: M.D. Anderson Cancer Center
First posted: 2012-07-17
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Emotional well-being
timeFrame: Change from pre-operative baseline up to three weeks post-operatively
Secondary outcomes:
measure: Body image
timeFrame: Change from pre-operative baseline up to three weeks post-operatively
measure: Anxiety
timeFrame: Change from pre-operative baseline up to three weeks post-operatively
measure: Depression
timeFrame: Change from pre-operative baseline up to three weeks post-operatively
measure: Use of mirrors
timeFrame: Up to three weeks post-operatively
Other outcomes:
Locations:
city: Houston
country: United States
facility: Memorial Hermann Healthcare System
state: Texas
city: Houston
country: United States
facility: Texas Woman's University
state: Texas
Study officials:
affiliation: Texas Woman's University
name: Wyona M. Freysteinson, PhD, MN
role: PRINCIPAL_INVESTIGATOR
References:
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.