Breast Cancer
Conditions
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.
Interventions
BEHAVIORALYoga 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.
BEHAVIORALAttention 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.
Sponsors
Medical University of South Carolina
PranaScience Institute LLC
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Practice Time as Assessed in Minutes Within the Study Application. | 12 weeks | Adherence will be evaluated by assessing total practice times by length in minutes. |
| Practice Frequency as a Measure of Adherence | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Stress (Perceived Stress Scale-10) | 12 weeks | 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. |
| Change in Depression Symptoms (Depression Scale) | 12 weeks | 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. |
| Change in Symptom Burden (MD Anderson Symptom Inventory) | 12 weeks | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSundar Balasubramanian, PhD
PranaScience; Medical University of South Carolina
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Region of Enrollment United States | 31 Participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 17 |
| other Total, other adverse events | 0 / 14 | 0 / 17 |
| serious Total, serious adverse events | 0 / 14 | 0 / 17 |
Outcome results
None listed