Breathwork App for Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Pilot Study of Group Video Yogic Breathing App in Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05161260
• Other study ID #: 108511
• Secondary ID: 1R41CA254557-01A
• Status: Completed
• Phase: N/A
• Start date: November 17, 2021
• Est. completion date: November 30, 2023

Study information

• Verified date: March 2024
• Source: PranaScience Institute LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Sundar Balasubramanian	National Cancer Institute (NCI), PranaScience Institute LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total practice time as assessed in minutes within the study application.	Adherence will be evaluated by assessing total practice times by length in minutes.	12 weeks
Primary	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.	12 weeks
Primary	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.	12 weeks
Primary	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.	12 weeks
Primary	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.	12 weeks
Primary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	16 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks