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Breathwork App for Cancer Survivors

Primary Purpose

Breast Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Yoga Breathing
Attention Control
Sponsored by
Sundar Balasubramanian
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Yoga Breathing (YB)

Attention Control

Arm Description

A first production version of a mobile application that guides users through proscribed yoga breathing exercises.

A first production version of a mobile application that guides users through an attention control activity, presented as methods for mindfulness.

Outcomes

Primary Outcome Measures

Total practice time as assessed in minutes within the study application.
Adherence will be evaluated by assessing total practice times by length in minutes.
Total practice time as assessed in frequency of using the study application.
Adherence will be evaluated by assessing total practice times by total number of times per day using the application.
Participants' symptom management as measured by emotional disposition.
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.
Participants' symptom management as measured by the System Usability Scale.
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.
Participants' symptom management as measured by a focus group.
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.
Feasibility of study application measured by participant ability to perform all study procedures.
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

Behavioral Survey Measures through Perceived Stress.
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.
Behavioral Survey Measures through Depression Scale.
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.
Behavioral Survey Measures through MD Anderson Symptom Inventory.
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.
Study participant focus group interviews.
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.
Exploratory salivary biomarkers to indicate changes.
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.
Exploratory fingernail biomarkers to indicate changes.
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.

Full Information

First Posted
November 5, 2021
Last Updated
June 7, 2023
Sponsor
Sundar Balasubramanian
Collaborators
PranaScience Institute LLC, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05161260
Brief Title
Breathwork App for Cancer Survivors
Official Title
Pilot Study of Group Video Yogic Breathing App in Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 17, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sundar Balasubramanian
Collaborators
PranaScience Institute LLC, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Yoga Breathing (YB)
Arm Type
Experimental
Arm Description
A first production version of a mobile application that guides users through proscribed yoga breathing exercises.
Arm Title
Attention Control
Arm Type
Experimental
Arm Description
A first production version of a mobile application that guides users through an attention control activity, presented as methods for mindfulness.
Intervention Type
Behavioral
Intervention Name(s)
Yoga Breathing
Other Intervention Name(s)
YB
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Attention Control
Other Intervention Name(s)
Mindfulness
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total practice time as assessed in minutes within the study application.
Description
Adherence will be evaluated by assessing total practice times by length in minutes.
Time Frame
12 weeks
Title
Total practice time as assessed in frequency of using the study application.
Description
Adherence will be evaluated by assessing total practice times by total number of times per day using the application.
Time Frame
12 weeks
Title
Participants' symptom management as measured by emotional disposition.
Description
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.
Time Frame
12 weeks
Title
Participants' symptom management as measured by the System Usability Scale.
Description
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.
Time Frame
12 weeks
Title
Participants' symptom management as measured by a focus group.
Description
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.
Time Frame
12 weeks
Title
Feasibility of study application measured by participant ability to perform all study procedures.
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Behavioral Survey Measures through Perceived Stress.
Description
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.
Time Frame
12 weeks
Title
Behavioral Survey Measures through Depression Scale.
Description
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.
Time Frame
12 weeks
Title
Behavioral Survey Measures through MD Anderson Symptom Inventory.
Description
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.
Time Frame
12 weeks
Title
Study participant focus group interviews.
Description
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.
Time Frame
16 weeks
Title
Exploratory salivary biomarkers to indicate changes.
Description
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.
Time Frame
12 weeks
Title
Exploratory fingernail biomarkers to indicate changes.
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sundar Balasubramanian, PhD
Organizational Affiliation
PranaScience; Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Plan to Share 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.

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Breathwork App for Cancer Survivors

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