Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
37 participants
INTERVENTIONAL
2021-11-17
2023-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Yoga Breathing (YB)
A first production version of a mobile application that guides users through proscribed yoga breathing exercises.
Yoga Breathing
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.
Attention Control
A first production version of a mobile application that guides users through an attention control activity, presented as methods for mindfulness.
Attention Control
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.
Interventions
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Yoga Breathing
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.
Attention Control
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of Stage 0-III breast cancer.
3. Completion of radiation therapy within the last 6 months.
4. ECOG performance status of 0-3 during cancer treatment.
5. Orally expressed visual and auditory acuity adequate for filling out all study forms and participating in telephone interviews and internet-based group video applications.
6. Access to telephone and internet-connected computer or mobile phone.
Exclusion Criteria
2. Orally expressed dependence on alcohol or drugs.
18 Years
FEMALE
No
Sponsors
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PranaScience Institute LLC
INDUSTRY
National Cancer Institute (NCI)
NIH
Sundar Balasubramanian
INDUSTRY
Responsible Party
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Sundar Balasubramanian
Principal Investigator, Founder, Owner
Principal Investigators
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Sundar Balasubramanian, PhD
Role: PRINCIPAL_INVESTIGATOR
PranaScience; Medical University of South Carolina
Locations
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Medical University of South Carolina
Charleston, South Carolina, United States
Countries
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References
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Balasubramanian S, Harper J, Sterba KR, Viswanathan R, Eldredge-Hindy H. Protocol for the Pilot Study of Group Video Yogic Breathing App in Breast Cancer Survivors. Int J Aayush Tradit Med. 2022;2(2):38-57. Epub 2022 Sep 28.
Other Identifiers
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