Breast CancerNCT05161260
Breathwork App for Cancer Survivors
A study testing Yoga Breathing in people with Breast Cancer, run by Medical University of South Carolina at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Yoga Breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2021to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Subject is unwilling or unable to comply with any of the study procedures.
- Orally expressed dependence on alcohol or drugs.
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Yoga Breathing, Attention Control
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga BreathingBehavioural
Also called YB
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 ControlBehavioural
Also called Mindfulness
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.
| Study group | Role | What they receive |
|---|---|---|
| Yoga Breathing (YB) | Experimental | A first production version of a mobile application that guides users through proscribed yoga breathing exercises. Receives: 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. Receives: Behavioral: Attention Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Practice Time as Assessed in Minutes Within the Study Application.
Adherence will be evaluated by assessing total practice times by length in minutes.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2021
- Study start17 Nov 2021
- Primary completion30 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Collaborators
- PranaScience Institute LLC, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Sundar Balasubramanian, PhD, Principal investigator, PranaScience; Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05161260
- Sponsor's protocol ID
- 108511
- Other IDs
- 1R41CA254557-01A1, R41CA254557
- Status last verified
- Feb 2026
- First submitted
- 5 Nov 2021
- Last updated
- 11 Mar 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 36790946
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Group Video Yogic Breathing App in Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT05161260
- Acronym / sponsor ID
- 108511
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Collaborators
- PranaScience Institute LLC, National Cancer Institute (NCI)
- Study start
- 17 Nov 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 17 Dec 2021 (actual)
- Results
- Posted 11 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga Breathing (YB) | Experimental | Behavioral: Yoga BreathingA first production version of a mobile application that guides users through proscribed yoga breathing exercises. |
| Attention Control | Experimental | Behavioral: Attention ControlA first production version of a mobile application that guides users through an attention control activity, presented as methods for mindfulness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Subject is unwilling or unable to comply with any of the study procedures.
- Orally expressed dependence on alcohol or drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga BreathingAlso: YBFor 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. | Behavioural | Yoga Breathing (YB) |
| Attention ControlAlso: MindfulnessFor 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. | Behavioural | Attention Control |
Primary outcome
Total Practice Time as Assessed in Minutes Within the Study Application.
Time frame: 12 weeks
Adherence will be evaluated by assessing total practice times by length in minutes.
Practice Frequency as a Measure of Adherence
Time frame: 12 weeks
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.
Participants' Symptom Management as Measured by the System Usability Scale.
Time frame: 12 weeks
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.
3 secondary outcomes
Change in Perceived Stress (Perceived Stress Scale-10)
Time frame: 12 weeks
Change in Depression Symptoms (Depression Scale)
Time frame: 12 weeks
Change in Symptom Burden (MD Anderson Symptom Inventory)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36790946Balasubramanian 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sundar Balasubramanian, PhD principal investigator
PranaScience; Medical University of South Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga Breathing in people with Breast Cancer, run by Medical University of South Carolina at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Practice Time as Assessed in Minutes Within the Study Application. (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05161260, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.