Breathwork App for Cancer Survivors

NCT05161260 | Completed Results

• 3 other identifiers: 1085111R41CA254557-01A1R41CA254557
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Change in Perceived Stress (Perceived Stress Scale-10)

  12 weeks

• Change in Depression Symptoms (Depression Scale)

  12 weeks

• Change in Symptom Burden (MD Anderson Symptom Inventory)

  12 weeks

Study Arms (2)

Yoga Breathing (YB)

EXPERIMENTAL

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

Behavioral: Yoga Breathing

Attention Control

EXPERIMENTAL

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

Behavioral: Attention Control

Interventions

Yoga Breathing BEHAVIORAL

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.

Also known as: YB

Yoga Breathing (YB)

Attention Control BEHAVIORAL

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.

Also known as: Mindfulness

Attention Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subject is unwilling or unable to comply with any of the study procedures.
• Orally expressed dependence on alcohol or drugs.

Sponsors & Collaborators

• PranaScience Institute LLC: collaborator
• National Cancer Institute (NCI): collaborator
• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (1)

• 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.

  PMID: 36790946 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Founder & Principal
• Organization: PranaScience Institute LLC

sundara@gmail.com

8438647787

Study Officials

• Sundar Balasubramanian, PhD

  PranaScience; Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 17, 2021
• Study Start: November 17, 2021
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: March 11, 2026
• Results First Posted: March 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)