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Trial record 1 of 1 for:    pranascience
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Breathwork App for Cancer Survivors

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ClinicalTrials.gov Identifier: NCT05161260
Recruitment Status : Recruiting
First Posted : December 17, 2021
Last Update Posted : August 1, 2022
Sponsor:
Collaborators:
PranaScience Institute LLC
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Sundar Balasubramanian, PranaScience Institute LLC

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Behavioral: Yoga Breathing Behavioral: Attention Control Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Pilot Study of Group Video Yogic Breathing App in Breast Cancer Survivors
Actual Study Start Date : November 17, 2021
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Yoga Breathing (YB)
A first production version of a mobile application that guides users through proscribed yoga breathing exercises.
 Behavioral: 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.
Other Name: YB
Experimental: Attention Control
A first production version of a mobile application that guides users through an attention control activity, presented as methods for mindfulness.
 Behavioral: 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 Name: Mindfulness


Outcome Measures
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Primary Outcome Measures :
  1. Total practice time as assessed in minutes within the study application. [ Time Frame: 12 weeks ]
    Adherence will be evaluated by assessing total practice times by length in minutes.

  2. Total practice time as assessed in frequency of using the study application. [ Time Frame: 12 weeks ]
    Adherence will be evaluated by assessing total practice times by total number of times per day using the application.

  3. Participants' symptom management as measured by emotional disposition. [ Time Frame: 12 weeks ]
    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.

  4. Participants' symptom management as measured by the System Usability Scale. [ Time Frame: 12 weeks ]
    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.

  5. Participants' symptom management as measured by a focus group. [ Time Frame: 12 weeks ]
    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.

  6. Feasibility of study application measured by participant ability to perform all study procedures. [ Time Frame: 12 weeks ]
    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.


Secondary Outcome Measures :
  1. Behavioral Survey Measures through Perceived Stress. [ Time Frame: 12 weeks ]
    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.

  2. Behavioral Survey Measures through Depression Scale. [ Time Frame: 12 weeks ]
    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.

  3. Behavioral Survey Measures through MD Anderson Symptom Inventory. [ Time Frame: 12 weeks ]
    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.

  4. Study participant focus group interviews. [ Time Frame: 16 weeks ]
    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.

  5. 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.

  6. Exploratory fingernail biomarkers to indicate changes. [ Time Frame: 12 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or older, willing to provide informed consent.
  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:

  1. Subject is unwilling or unable to comply with any of the study procedures.
  2. Orally expressed dependence on alcohol or drugs.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05161260


Contacts
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Contact: Emily Richardson, MPH 843-792-8352 richaemi@musc.edu
Contact: Jennifer Harper 843-792-3271 harperjl@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Emily Richardson, MPH    843-792-8352    richaemi@musc.edu   
Contact: Jennifer Harper    843-792-3271    harperjl@musc.edu   
Principal Investigator: Sundar Balasubramanian, PhD         
Sponsors and Collaborators
Sundar Balasubramanian
PranaScience Institute LLC
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Sundar Balasubramanian, PhD PranaScience; Medical University of South Carolina
More Information
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Responsible Party: Sundar Balasubramanian, Principal Investigator, Founder, Owner, PranaScience Institute LLC
ClinicalTrials.gov Identifier: NCT05161260    
Other Study ID Numbers: 108511
1R41CA254557-01A1 ( U.S. NIH Grant/Contract )
R41CA254557 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2021    Key Record Dates
Last Update Posted: August 1, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases