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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02793076
Other study ID # 840697-4
Secondary ID
Status Completed
Phase N/A
First received May 23, 2016
Last updated June 2, 2016
Start date February 2016
Est. completion date May 2016

Study information

Verified date June 2016
Source University of the Sciences in Philadelphia
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this mixed methods study is to evaluate the effects an 8-week group dance intervention can have on body image and posture in breast cancer survivors.


Description:

The purpose of this mixed methods study is to evaluate the effects of an 8-week group dance intervention on body image and posture in breast cancer survivors.

Program Description: An 8-week dance intervention was held at a local cancer support center in the greater Philadelphia region. The study ran for 8 weeks, and each class was held once a week for 60 minutes. Every class consisted of a 5-10 minute stretching warm up leading to approximately 50 minutes of teaching light choreography set to Bollywood music.

Methods: This was a mixed methods study utilizing two quantitative assessments and a qualitative portion comprising of initial and exit surveys. Breast cancer survivors were recruited from a local non-profit cancer support community in the greater Philadelphia region. A sample of twelve women (n=12) fulfilled inclusion criteria of being diagnosed with and treated for breast cancer. Dropout rate was low, and only 1 person fit this criteria. Informed consent was sought after and obtained through the University of the Sciences in Philadelphia Institutional Review Board.

Procedure: Group dance intervention program lasted for 8 weeks in total with no control group. All twelve subjects participated in 60-minute dance sessions, once a week for 8 weeks. At the beginning and termination of this 8 week dance intervention, all subjects took a series of assessments including the Body Image Scale (BIS), postural assessment using the plumbline method, and initial and exit open-ended surveys to assess any additional benefits of the program.

Analysis: Data review was completed through Microsoft Excel and SOFA Statistics (version 1.4.6), a free statistical analysis program (available online for download at www.sofastatistics.com). Means and modes were found in demographics using Excel. Qualitative data was explored initially through reading surveys and noting repetitive points. Survey data was coded by highlighting and labeling segments of common responses to survey questions. To ensure findings were consistent, an independent reviewer was employed to verify coded data. Codes were later organized according to similarity to develop common themes. Themes found from initial and exit surveys were studied closer using a comparative analysis, to look for connecting themes from initial and exit surveys.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date May 2016
Est. primary completion date May 2016
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Being diagnosed with and treated for breast cancer

Exclusion Criteria:

- Participants who attended less than 6 classes

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Bollywood Dance
8 week Bollywood Dance Program

Locations

Country Name City State
United States Cancer Support Community Philadelphia Pennsylvania

Sponsors (2)

Lead Sponsor Collaborator
University of the Sciences in Philadelphia Cancer Support Community of Greater Philadelphia

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Body Image Scale (BIS) BIS is a 10-item likert scale questionnaire developed to assess body image. In a study by Hopwood et al. (2001), the BIS showed high reliability (Cronbach's alpha=0.93) and good clinical and discriminant validity. Day 1(at start of dance intervention) and 8 weeks (at conclusion of dance intervention No
Primary Change in Plumbline Photographs were taken from a lateral view to assess shoulder posture. After palpating for the acromion joint, a tape marker was placed on the mid-acromion process. Participants were asked to stand with feet hip distance apart and look straight ahead. A full body picture was then taken from the lateral profile view. Pages for Apple, a computer software available through Mac (versions 10.11.3 and higher) was used to place a digital plumbline marker, which was perpendicular to the lateral malleolus on each photo. A second digital line was placed perpendicular from the mid-acromion process to the plumbline marker. The horizontal distance from the mid-acromion process to the plumbline marker was measured (inches) for each photo. Day 1(at start of dance intervention) and 8 weeks (at conclusion of dance intervention No
Primary Change in Qualitative Open Ended Surveys Initial and exit open-ended surveys to assess any additional benefits of the program Day 1(at start of dance intervention) and 8 weeks (at conclusion of dance intervention No
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