Clinical trial NCT05161260: Breathwork App for Cancer Survivors
Official title: Pilot Study of Group Video Yogic Breathing App in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: PranaScience Institute LLC
Sponsor class: INDUSTRY
Collaborators: name: PranaScience Institute LLC
name: National Cancer Institute (NCI)
First posted: 2021-12-17
Enrollment: 37
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Total practice time as assessed in minutes within the study application.
timeFrame: 12 weeks
measure: Total practice time as assessed in frequency of using the study application.
timeFrame: 12 weeks
measure: Participants' symptom management as measured by emotional disposition.
timeFrame: 12 weeks
measure: Participants' symptom management as measured by the System Usability Scale.
timeFrame: 12 weeks
measure: Participants' symptom management as measured by a focus group.
timeFrame: 12 weeks
measure: Feasibility of study application measured by participant ability to perform all study procedures.
timeFrame: 12 weeks
Secondary outcomes:
measure: Behavioral Survey Measures through Perceived Stress.
timeFrame: 12 weeks
measure: Behavioral Survey Measures through Depression Scale.
timeFrame: 12 weeks
measure: Behavioral Survey Measures through MD Anderson Symptom Inventory.
timeFrame: 12 weeks
measure: Study participant focus group interviews.
timeFrame: 16 weeks
measure: Exploratory salivary biomarkers to indicate changes.
timeFrame: 12 weeks
measure: Exploratory fingernail biomarkers to indicate changes.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: PranaScience; Medical University of South Carolina
name: Sundar Balasubramanian, PhD
role: PRINCIPAL_INVESTIGATOR
References: