Study of Fine Art Photographs and Visualization Tapes to Improve Surgical Recovery in Breast Cancer

Not Applicable

Terminated

• Conditions: Breast Neoplasms
• Interventions: Behavioral: Visualization relaxation; Behavioral: Visual Milieu Enhancement (Fine art photograph)

• Registration Number: NCT00179634
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief Summary

This is a study to assess whether healing suggestions and enhancing visual milieu (large fine art photographs) will improve mental and physical measures of well-being and recovery from surgery. The study will compare breast cancer patients undergoing identical skin sparing mastectomy and reconstruction surgery randomized to three groups:

1. Usual care control group

2. Usual care and exposure to fine art photograph

3. Usual care and fine art photograph and guided visualization tapes.

Detailed Description

In the course of surgical procedures and hospitalization, patients are stressed not only by the discomforts and anxieties associated with their illness and treatment but also by the sterile, intimidating medical environment, with no access to the natural environment. Clinical studies from environmental medicine have suggested that during hospital confinement patients benefit from visually pleasing décor. Enhancing the medical milieu can alleviate patient anxiety and discomfort as well as improve markers of stress such as blood pressure and requirement for analgesics. In addition, research has shown the effectiveness of stress reduction approaches such as Relaxation Response, Guided Imagery, and Hypnosis in mediating clinical psychophysiology overall. Such studies have also shown the lowering of stress levels, inducing faster recovery from surgical anesthesia and perhaps even speeding physical healing overall. Use of these techniques has been shown to give people a greater sense of self-control as well and reduce stress reactions that affect health.

The proposed study represents the next step testing clinical efficacy of a behavioral medicine intervention with breast cancer patients undergoing mastectomy and reconstruction surgery. The current study extends prior research on accelerating healing outcomes through the use of non-pharmacological mental interventions. One prior study demonstrated accelerated bone fracture healing using hypnosis in otherwise healthy young adults. A second study showed enhanced post-surgical wound healing in healthy women undergoing reduction mammoplasty. The current study will generate new data about enhancing outcomes for breast cancer patients undergoing mastectomy and reconstruction. The goal of the trial is to determine whether these ancillary treatments enhance psychological and physical post-surgical recovery as compared to usual care only. The study provides an upside potential to enhance patient well being and to accelerate post-surgical recovery with minimal risk. Should significant positive findings result from this study, it will constitute a pilot test of such modifications of the healthcare delivery environment with an eye toward stimulating greater patient well being and shorter length of stay.

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-16
• Primary Completion: 2008-03-27
• Study Completion: 2008-03-27
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-22
• Last Update Posted: 2017-03-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• Diagnosis of stage 0, I, or II breast cancer
• Skin sparing mastectomy with transverse rectus abdominal muscle (TRAM) or deep inferior epigastric perforator (DIEP) flap reconstruction planned
• Ability to give informed consent
• Working knowledge of English

Exclusion Criteria

• Physical inability to comply to study protocol
• Diabetes
• Current smokers
• Acute psychosis
• Mental retardation
• Language barriers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Visualization relaxation	Usual care, exposure to a visually enriched milieu and audio taped guided visualization with healing suggestions.
3	Visual Milieu Enhancement (Fine art photograph)	Usual care, exposure to a visually enriched milieu and audio taped guided visualization with healing suggestions.
2	Visual Milieu Enhancement (Fine art photograph)	Usual care and exposure to a visually enriched milieu (landscape photograph)

Primary Outcome Measures

Name	Time	Method
Presence of hematoma	4 weeks
Presence of skin necrosis	4 weeks
Mood disturbance (Profile of Mood States short form)	4 weeks
Post-operative pain	4 weeks
Length of hospital stay	4 weeks
Presence of infection	4 weeks

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States