CancerNCT02793076
Physical and Emotional Benefits of Group Dance Intervention for Breast Cancer Survivors
A study testing Bollywood Dance in people with Cancer, run by University of the Sciences in Philadelphia at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Bollywood Dance
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being diagnosed with and treated for breast cancer
Who cannot join
- Participants who attended less than 6 classes
Trial locations and contacts
1 site in 1 country.
United States1 site
Cancer Support Community
Philadelphia, Pennsylvania, 19131
About this study
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.
Read the detailed 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.
- Conditions
- Cancer
- Being tested
- Bollywood Dance
- Keywords
- Posture, Body image, Dancing, Group, Survivors
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bollywood DanceOther
8 week Bollywood Dance Program
| Study group | Role | What they receive |
|---|---|---|
| Bollywood Dance | Experimental | Bollywood dance is a routine that doubles as both physical and mental exercise. Receives: Other: Bollywood Dance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1(at start of dance intervention) and 8 weeks (at conclusion of dance intervention
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.
Measured: Day 1(at start of dance intervention) and 8 weeks (at conclusion of dance intervention
Change in Qualitative Open Ended Surveys
Initial and exit open-ended surveys to assess any additional benefits of the program
Measured: Day 1(at start of dance intervention) and 8 weeks (at conclusion of dance intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startFeb 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Sciences in Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Support Community of Greater Philadelphia
- Responsible party
- Principal investigator, Colleen Maher, University of the Sciences in Philadelphia
- Investigators
- Colleen Maher, OTD, Principal investigator, University of the Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793076
- Sponsor's protocol ID
- 840697-4
- Status last verified
- Jun 2016
- First submitted
- 23 May 2016
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical and Emotional Benefits of Group Dance Intervention for Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT02793076
- Acronym / sponsor ID
- 840697-4
- Conditions
- Cancer
- Keywords
- Posture, Body image, Dancing, Group, Survivors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of the Sciences in PhiladelphiaUniversity, hospital or other
- Collaborators
- Cancer Support Community of Greater Philadelphia
- Study start
- Feb 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bollywood Dance | Experimental | Other: Bollywood DanceBollywood dance is a routine that doubles as both physical and mental exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Being diagnosed with and treated for breast cancer
Key exclusion criteria (1 listed)
- Participants who attended less than 6 classes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bollywood Dance8 week Bollywood Dance Program | Other | Bollywood Dance |
Primary outcome
Change in Body Image Scale (BIS)
Time frame: Day 1(at start of dance intervention) and 8 weeks (at conclusion of dance intervention
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.
Change in Plumbline
Time frame: Day 1(at start of dance intervention) and 8 weeks (at conclusion of dance intervention
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.
Change in Qualitative Open Ended Surveys
Time frame: Day 1(at start of dance intervention) and 8 weeks (at conclusion of dance intervention
Initial and exit open-ended surveys to assess any additional benefits of the program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Colleen Maher, OTD principal investigator
University of the Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bollywood Dance in people with Cancer, run by University of the Sciences in Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Body Image Scale (BIS) (time frame: Day 1(at start of dance intervention) and 8 weeks (at conclusion of dance intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2016.