Breathwork App for Cancer Survivors

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: Breast Cancer
• Intervention / Treatment: Behavioral: Yoga Breathing; Behavioral: Attention Control

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

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.	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 Names: 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 Names: Mindfulness

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.	Adherence will be evaluated by assessing total practice times by length in minutes.	12 weeks
Practice Frequency as a Measure of Adherence	Adherence is assessed by quantifying the number of completed app-based practice sessions relative to the total number of available sessions over 12 weeks. Each practice session is defined as a 10-minute, app-timed exercise, automatically logged in the mobile application's backend (including both individual and group sessions). Adherence is operationalized as: Practice Frequency = total number of completed sessions Practice Proportion = completed sessions ÷ total possible sessions (180 sessions maximum; 3 sessions/day × 5 days/week × 12 weeks). Both metrics are captured automatically by the app, which records each timed session as a completed practice. Higher values indicate greater adherence.	12 weeks
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. The acceptability is defined as a value of at least 68% in System Usability Scale. The values 0.6 and 0.2 represent 60% and 20% respectively. The higher percentage indicates greater system usability (meaning acceptability) of the app.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Perceived Stress (Perceived Stress Scale-10)	The Perceived Stress Scale-10 (PSS-10) is a validated 10-item questionnaire assessing perceived stress over the past month. Each item is scored 0-4, yielding a total score range of 0-40, where higher scores indicate greater perceived stress. Scores are transformed into T-scores, standardized to a population mean of 50 with a standard deviation of 10. Higher T-scores = worse stress Lower T-scores = improved stress The outcome reported is the change in T-score from baseline to Week 12, with negative values indicating improvement in perceived stress. The use of T-scores supports comparison to normative samples and aligns with protocol-defined behavioral survey measures collected at Weeks 1 and 12.	12 weeks
Change in Depression Symptoms (Depression Scale)	Depression is measured using a validated 4-item Depression Scale with response options ranging from "Not at all" (0) to "Most of the time" (3). Total scores range from 0-12, with higher scores indicating worse depressive symptoms. Scores are converted into standardized T-scores (mean 50, SD 10). The outcome reflects the change in T-score from baseline to Week 12: Negative change = reduction in depressive symptoms (improvement). Positive change = increased symptoms (worsening). This description aligns with the protocol's Behavioral Survey Measures section, which includes depression assessed at Week 1 and Week 12.	12 weeks
Change in Symptom Burden (MD Anderson Symptom Inventory)	The MD Anderson Symptom Inventory (MDASI) assesses 13 symptoms on a scale of 0-10, where 0 = no symptom and 10 = worst imaginable symptom. The outcome is the change in mean symptom severity score from baseline (Week 1) to Week 12. Negative values indicate improvement (reduction in symptom burden). Positive values indicate worsening (increase in symptom burden). This aligns with the protocol, which identifies MDASI as a secondary behavioral survey measure collected at Weeks 1 and 12, with clinically meaningful changes defined as 0.5 SD differences.	12 weeks

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Collaborators: National Cancer Institute (NCI); PranaScience Institute LLC
• Investigators: Principal Investigator: Sundar Balasubramanian, PhD, PranaScience; Medical University of South Carolina

Publications and helpful links

General Publications

• 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.

Study record dates

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): March 11, 2026
• Last Update Submitted That Met QC Criteria: February 17, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness
• 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