- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05161260
Breathwork App for Cancer Survivors
March 30, 2024 updated by: Sundar Balasubramanian
Pilot Study of Group Video Yogic Breathing App in Breast Cancer Survivors
Cancer survivorship is associated with many long-term chronic health issues that arise as a result of cancer treatment protocols.
Non-pharmacological lifestyle and mind-body interventions have been shown to be effective and critical components of a total-health strategy for cancer survivors.
PranaScience Institute seeks to develop and test a novel group video app for home-based delivery of a Yogic Breathing intervention that reduces symptoms of cancer treatment survival and supports total-health.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
37
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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South Carolina
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Charleston, South Carolina, United States, 29425
- Medical University of South Carolina
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age 18 years or older, willing to provide informed consent.
- Diagnosis of Stage 0-III breast cancer.
- Completion of radiation therapy within the last 6 months.
- ECOG performance status of 0-3 during cancer treatment.
- Orally expressed visual and auditory acuity adequate for filling out all study forms and participating in telephone interviews and internet-based group video applications.
- Access to telephone and internet-connected computer or mobile phone.
Exclusion Criteria:
- Subject is unwilling or unable to comply with any of the study procedures.
- Orally expressed dependence on alcohol or drugs.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Yoga Breathing (YB)
A first production version of a mobile application that guides users through proscribed yoga breathing exercises.
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For the12 weeks, participants will be asked to use the mobile study app, completing 3, 10 minute exercises, 5 days a week.
Participants in the Yoga Breathing group will practice a breathing exercise guided by the mobile study application.
The application will also send "nudges" and reminders throughout the day.
Participants will engage with the research study app along with other participants in groups of 2-7 at their own convenience.
Participants may practice their breathing activity with either a group of participants, through the video conferencing feature of the app, or on their own.
The study instructor may join sessions on a random basis to ensure compliance with the technique and to clarify any questions participants may have.
Other Names:
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Experimental: Attention Control
A first production version of a mobile application that guides users through an attention control activity, presented as methods for mindfulness.
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For the12 weeks, participants will be asked to use the mobile study app, completing 3, 10 minute exercises, 5 days a week.
Participants in the Attention Control group will practice a mindfulness exercise guided by the mobile study application.
The application will also send "nudges" and reminders throughout the day.
Participants will engage with the research study app along with other participants in groups of 2-7 at their own convenience.
Participants may practice their mindfulness activity with either a group of participants, through the video conferencing feature of the app, or on their own.
The study instructor may join sessions on a random basis to ensure compliance with the technique and to clarify any questions participants may have.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total practice time as assessed in minutes within the study application.
Time Frame: 12 weeks
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Adherence will be evaluated by assessing total practice times by length in minutes.
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12 weeks
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Total practice time as assessed in frequency of using the study application.
Time Frame: 12 weeks
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Adherence will be evaluated by assessing total practice times by total number of times per day using the application.
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12 weeks
|
Participants' symptom management as measured by emotional disposition.
Time Frame: 12 weeks
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Acceptability measures the participant's symptom management throughout the study duration.
Participant's emotional disposition at the beginning and end of each study session with the Smiley Face Likert Scale, exhibiting as Very Poor, Poor, Average, Good, or Excellent to measure participants' acceptability of the study application.
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12 weeks
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Participants' symptom management as measured by the System Usability Scale.
Time Frame: 12 weeks
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Acceptability measures the participant's symptom management throughout the study duration.
This is measured using The System Usability Scale (SUS) questionnaire, a 10 item questionnaire with 5 response options ranging from 'Strong Agree' to 'Strong Disagree'.
The questionnaire will be administered at the end of 12 weeks to measure participants' acceptability of the study application.
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12 weeks
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Participants' symptom management as measured by a focus group.
Time Frame: 12 weeks
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Acceptability measures the participant's symptom management throughout the study duration.
Input from end of study Focus Groups will be used to measure participants' acceptability of the study application.
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12 weeks
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Feasibility of study application measured by participant ability to perform all study procedures.
Time Frame: 12 weeks
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Feasibility for use of study application will be measured by evaluating intervention delivery factors, which will be evaluated throughout the program period by examining the total number of participants who completed all study sessions.
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12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Behavioral Survey Measures through Perceived Stress.
Time Frame: 12 weeks
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Behavioral survey measures will be collected from all participants at study start and study termination using established questionnaires: Perceived Stress Scale (PSS), a 10 item questionnaire with 5 response options ranging from 'Never' to 'Very Often', with 'Very Often' being a worse outcome.
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12 weeks
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Behavioral Survey Measures through Depression Scale.
Time Frame: 12 weeks
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Behavioral survey measures will be collected from all participants at study start and study termination using established questionnaires: Depression Scale, a questionnaire with 4 response options ranging from 'Not at all' to 'Most of the time', with 'Most of the time' being a worse outcome.
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12 weeks
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Behavioral Survey Measures through MD Anderson Symptom Inventory.
Time Frame: 12 weeks
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Behavioral survey measures will be collected from all participants at study start and study termination using established questionnaires: MD Anderson Symptom Inventory, a 13 symptom list with responses on a scale of 0 to 10, with 10 being the worst outcome.
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12 weeks
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Study participant focus group interviews.
Time Frame: 16 weeks
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Structured focus group interviews completed approximately 1 month after the end of the 12 week intervention.
This will assess participants' general perceptions of the intervention and technology.
During these interviews, data will be collected to identify recommendations for app modifications and improved adherence.
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16 weeks
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Exploratory salivary biomarkers to indicate changes.
Time Frame: 12 weeks
|
Participants will each be asked to provide a total of 8 saliva samples (1 pre and post study session at Week 1 and Week 12).
Proteomic, multiplex, and ELISA will be used to measure changes in cytokines, tumor suppressors, and cortisol.
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12 weeks
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Exploratory fingernail biomarkers to indicate changes.
Time Frame: 12 weeks
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Participants will each be asked to provide a total of 16 fingernail samples (8 at Week 1 and 8 at Week 12).
Proteomic, multiplex, and ELISA will be used to measure changes in cytokines, tumor suppressors, and cortisol.
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12 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sundar Balasubramanian, PhD, PranaScience; Medical University of South Carolina
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 17, 2021
Primary Completion (Actual)
November 30, 2023
Study Completion (Actual)
November 30, 2023
Study Registration Dates
First Submitted
November 5, 2021
First Submitted That Met QC Criteria
December 3, 2021
First Posted (Actual)
December 17, 2021
Study Record Updates
Last Update Posted (Actual)
April 2, 2024
Last Update Submitted That Met QC Criteria
March 30, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 108511
- 1R41CA254557-01A1 (U.S. NIH Grant/Contract)
- R41CA254557 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Sharing Time Frame
: Individual participant data requests can be submitted starting 9 months after research article publication and the data will be made accessible for up to 24 months.
Extensions will be considered on a case-by-case basis.
IPD Sharing Access Criteria
"Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
For more information or to submit a request, please contact the PI.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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