Clinical trial NCT00179634: Study of Fine Art Photographs and Visualization Tapes to Improve Surgical Recovery in Breast Cancer
Official title: Using Visual Milieu Enrichment and Guided Visualization to Augment Patient Well-being and Post-surgical Recovery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Neoplasms
Keywords: Mastectomy
Randomized Controlled Trial
Imagery
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mood disturbance (Profile of Mood States short form)
timeFrame: 4 weeks
measure: Post-operative pain
timeFrame: 4 weeks
measure: Presence of skin necrosis
timeFrame: 4 weeks
measure: Presence of hematoma
timeFrame: 4 weeks
measure: Presence of infection
timeFrame: 4 weeks
measure: Length of hospital stay
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Susan L Troyan, MD
role: PRINCIPAL_INVESTIGATOR
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