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

Primary Purpose

Breast Neoplasms

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visualization relaxation
Visual Milieu Enhancement (Fine art photograph)
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Neoplasms focused on measuring Mastectomy, Randomized Controlled Trial, Imagery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Beth Israel Deaconess Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

1

2

3

Arm Description

Usual Care

Usual care and exposure to a visually enriched milieu (landscape photograph)

Usual care, exposure to a visually enriched milieu and audio taped guided visualization with healing suggestions.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
March 22, 2017
Sponsor
Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00179634
Brief Title
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

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Expired for lack of continuing review
Study Start Date
March 2005 (undefined)
Primary Completion Date
March 27, 2008 (Actual)
Study Completion Date
March 27, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: Usual care control group Usual care and exposure to fine art photograph 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Mastectomy, Randomized Controlled Trial, Imagery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Usual Care
Arm Title
2
Arm Type
Experimental
Arm Description
Usual care and exposure to a visually enriched milieu (landscape photograph)
Arm Title
3
Arm Type
Experimental
Arm Description
Usual care, exposure to a visually enriched milieu and audio taped guided visualization with healing suggestions.
Intervention Type
Behavioral
Intervention Name(s)
Visualization relaxation
Intervention Type
Behavioral
Intervention Name(s)
Visual Milieu Enhancement (Fine art photograph)
Primary Outcome Measure Information:
Title
Mood disturbance (Profile of Mood States short form)
Time Frame
4 weeks
Title
Post-operative pain
Time Frame
4 weeks
Title
Presence of skin necrosis
Time Frame
4 weeks
Title
Presence of hematoma
Time Frame
4 weeks
Title
Presence of infection
Time Frame
4 weeks
Title
Length of hospital stay
Time Frame
4 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan L Troyan, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

Citations:
Citation
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PubMed Identifier
9672340
Citation
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Citation
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PubMed Identifier
2012007
Citation
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Study of Fine Art Photographs and Visualization Tapes to Improve Surgical Recovery in Breast Cancer

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