Breathwork App for Cancer Survivors
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Attention ControlBehavioral: Yoga Breathing
- Registration Number
- NCT05161260
- Lead Sponsor
- Sundar Balasubramanian
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 37
- 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.
- Subject is unwilling or unable to comply with any of the study procedures.
- Orally expressed dependence on alcohol or drugs.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Attention Control Attention Control A first production version of a mobile application that guides users through an attention control activity, presented as methods for mindfulness. Yoga Breathing (YB) Yoga Breathing A first production version of a mobile application that guides users through proscribed yoga breathing exercises.
- Primary Outcome Measures
Name Time Method 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.
Total practice time as assessed in frequency of using the study application. 12 weeks Adherence will be evaluated by assessing total practice times by total number of times per day using the application.
Participants' symptom management as measured by emotional disposition. 12 weeks Acceptability measures the participant's symptom management throughout the study duration. Participant's emotional disposition at the beginning and end of each study session with the Smiley Face Likert Scale, exhibiting as Very Poor, Poor, Average, Good, or Excellent to measure participants' acceptability of the study application.
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.
Participants' symptom management as measured by a focus group. 12 weeks Acceptability measures the participant's symptom management throughout the study duration. Input from end of study Focus Groups will be used to measure participants' acceptability of the study application.
Feasibility of study application measured by participant ability to perform all study procedures. 12 weeks Feasibility for use of study application will be measured by evaluating intervention delivery factors, which will be evaluated throughout the program period by examining the total number of participants who completed all study sessions.
- Secondary Outcome Measures
Name Time Method Behavioral Survey Measures through MD Anderson Symptom Inventory. 12 weeks Behavioral survey measures will be collected from all participants at study start and study termination using established questionnaires: MD Anderson Symptom Inventory, a 13 symptom list with responses on a scale of 0 to 10, with 10 being the worst outcome.
Exploratory fingernail biomarkers to indicate changes. 12 weeks Participants will each be asked to provide a total of 16 fingernail samples (8 at Week 1 and 8 at Week 12). Proteomic, multiplex, and ELISA will be used to measure changes in cytokines, tumor suppressors, and cortisol.
Exploratory salivary biomarkers to indicate changes. 12 weeks Participants will each be asked to provide a total of 8 saliva samples (1 pre and post study session at Week 1 and Week 12). Proteomic, multiplex, and ELISA will be used to measure changes in cytokines, tumor suppressors, and cortisol.
Behavioral Survey Measures through Perceived Stress. 12 weeks Behavioral survey measures will be collected from all participants at study start and study termination using established questionnaires: Perceived Stress Scale (PSS), a 10 item questionnaire with 5 response options ranging from 'Never' to 'Very Often', with 'Very Often' being a worse outcome.
Behavioral Survey Measures through Depression Scale. 12 weeks Behavioral survey measures will be collected from all participants at study start and study termination using established questionnaires: Depression Scale, a questionnaire with 4 response options ranging from 'Not at all' to 'Most of the time', with 'Most of the time' being a worse outcome.
Study participant focus group interviews. 16 weeks Structured focus group interviews completed approximately 1 month after the end of the 12 week intervention. This will assess participants' general perceptions of the intervention and technology. During these interviews, data will be collected to identify recommendations for app modifications and improved adherence.
Trial Locations
- Locations (1)
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States