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

This study has been terminated.
(Expired for lack of continuing review)
Sponsor:
Information provided by:
Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT00179634
First received: September 13, 2005
Last updated: February 3, 2010
Last verified: February 2010
  Purpose

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.

Condition Intervention Phase
Breast Neoplasms
Behavioral: Visualization relaxation
Device: Visual Milieu Enhancement (Fine art photograph)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Using Visual Milieu Enrichment and Guided Visualization to Augment Patient Well-being and Post-surgical Recovery

Resource links provided by NLM:


Further study details as provided by Beth Israel Deaconess Medical Center:

Primary Outcome Measures:
  • Mood disturbance (Profile of Mood States short form) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Post-operative pain [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Presence of skin necrosis [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Presence of hematoma [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Presence of infection [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: March 2005
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Usual Care
Experimental: 2
Usual care and exposure to a visually enriched milieu (landscape photograph)
Device: Visual Milieu Enhancement (Fine art photograph)
Experimental: 3
Usual care, exposure to a visually enriched milieu and audio taped guided visualization with healing suggestions.
Behavioral: Visualization relaxation Device: Visual Milieu Enhancement (Fine art photograph)

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00179634

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Susan L Troyan, MD Beth Israel Deaconess Medical Center
  More Information

Publications:
Hartig T, Evans GW, Jammer LD, Davis DS, Garling T. Tracking restoration in natural and urban field settings. Journal of Environmental Psychology 23:109-23, 2003
Ewin DM.The effect of hypnosis and mental set on major surgery and burns. Psychiatric Annals 16:115-118, 1986.

Responsible Party: Susan L. Troyan MD, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT00179634     History of Changes
Other Study ID Numbers: 2004-P-000115; BIDMC, West
Study First Received: September 13, 2005
Last Updated: February 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Beth Israel Deaconess Medical Center:
Mastectomy
Randomized Controlled Trial
Imagery

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014