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| ID | Type | Description | Link |
|---|---|---|---|
| 1R41CA254557-01A1 | U.S. NIH Grant/Contract | View source | |
| R41CA254557 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| PranaScience Institute LLC | INDUSTRY |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Yoga Breathing (YB) | Experimental | A first production version of a mobile application that guides users through proscribed yoga breathing exercises. |
|
| Attention Control | Experimental | A first production version of a mobile application that guides users through an attention control activity, presented as methods for mindfulness. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sundar Balasubramanian, PhD | PranaScience; Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36790946 | Derived | 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. |
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: 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 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Yoga Breathing (YB) | A first production version of a mobile application that guides users through proscribed yoga breathing exercises. |
| FG001 | Attention Control | A first production version of a mobile application that guides users through an attention control activity, presented as methods for mindfulness. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Yoga Breathing (YB) | A first production version of a mobile application that guides users through proscribed yoga breathing exercises. |
| BG001 | Attention Control | A first production version of a mobile application that guides users through an attention control activity, presented as methods for mindfulness. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | 95% Confidence Interval | Minutes | 12 weeks |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Yoga Breathing (YB) | A first production version of a mobile application that guides users through proscribed yoga breathing exercises. 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Founder & Principal | PranaScience Institute LLC | 8438647787 | sundara@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 20, 2023 | Mar 27, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 22, 2021 | Mar 21, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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|
|
| 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. |
|
|
| 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Participants |
|
|
| Primary | 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. | Posted | Number | 95% Confidence Interval | Number of completed sessions | 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. 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. | Posted | Mean | 95% Confidence Interval | score on a scale | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | T-score | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | T-score | 12 weeks |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Error | score on a scale | 12 weeks |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Attention Control | A first production version of a mobile application that guides users through an attention control activity, presented as methods for mindfulness. 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. | 0 | 17 | 0 | 17 | 0 | 17 |
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| D017437 |
| Skin and Connective Tissue Diseases |