Breathwork App for Cancer Survivors

NCT ID: NCT05161260

Last Updated: 2024-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-17

Study Completion Date

2023-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Yoga Breathing (YB)

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

Group Type EXPERIMENTAL

Yoga Breathing

Intervention Type 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.

Attention Control

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

Group Type EXPERIMENTAL

Attention Control

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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YB Mindfulness

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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PranaScience Institute LLC

INDUSTRY

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Sundar Balasubramanian

INDUSTRY

Sponsor Role lead

Responsible Party

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Sundar Balasubramanian

Principal Investigator, Founder, Owner

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Sundar Balasubramanian, PhD

Role: PRINCIPAL_INVESTIGATOR

PranaScience; Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 36790946 (View on PubMed)

Other Identifiers

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1R41CA254557-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R41CA254557

Identifier Type: NIH

Identifier Source: secondary_id

View Link

108511

Identifier Type: -

Identifier Source: org_study_id

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