The Effect of Mirror Education for Women Undergoing Mastectomy

NCT ID: NCT01642628

Last Updated: 2014-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-12-31

Brief Summary

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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

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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.

Conditions

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Emotional Distress Anxiety Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Body Image/Mirror Education

Participants in the mirror arm will receive a mirror and mirror viewing education from oncology nurse navigators.

Group Type EXPERIMENTAL

Mirror Education

Intervention Type OTHER

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.

Standard Care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mirror Education

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.

Intervention Type OTHER

Other Intervention Names

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Experimental group

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Hermann Health System

OTHER

Sponsor Role collaborator

M.D. Anderson Cancer Center

OTHER

Sponsor Role collaborator

Texas Woman's University

OTHER

Sponsor Role lead

Responsible Party

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Wyona M. Freysteinson, PhD, MN

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wyona M. Freysteinson, PhD, MN

Role: PRINCIPAL_INVESTIGATOR

Texas Woman's University

Locations

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Memorial Hermann Healthcare System

Houston, Texas, United States

Site Status

Texas Woman's University

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22750894 (View on PubMed)

Other Identifiers

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17006

Identifier Type: -

Identifier Source: org_study_id

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