Breathing Practice for Brain and Mental Health in Cancer and Neurodegenerative Diseases
NCT ID: NCT06788886
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
147 participants
INTERVENTIONAL
2025-02-05
2027-01-18
Brief Summary
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Detailed Description
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I. To evaluate the immediate and long-term effects of improved respiratory function on local tissue oxygen delivery and cerebral circulation, by comparing control and training groups.
SECONDARY OBJECTIVE:
I. To identify key biological aspects of breathing related to brain health and mental well-being, our research explores how respiratory function can improve clinical symptoms related to fatigue and emotional states.
EXPLORATORY OBJECTIVE:
I. To establish a clinically applicable support tool that uses effective breathing practice to help patients, and their caregivers better navigate their clinical treatment.
OUTLINE: Participants are assigned to 1 of 3 studies.
STUDY 1: Participants are randomized to 1 of 2 groups.
GROUP 1: Participants engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. At month 4, participants are randomized to 1 of 2 subgroups.
SUBGROUP 1: Participants engage in breathing self-practice routines using a mobile app over 30 minutes daily for an additional 2 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants also undergo MRI scans throughout the study.
SUBGROUP 2: Participants discontinue breathing self-practice routines for the additional 2 months on study. Participants also undergo MRI scans throughout the study.
GROUP 2: Participants engage in walking self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may also participate in in-person group walking session with other participants weekly on study. At month 4, participants are randomized to 1 of 2 subgroups.
SUBGROUP 3: Participants engage in walking self-practice routines using a mobile app over 30 minutes daily for an additional 2 months on study. Participants may also participate in in-person group walking session with other participants weekly on study. Participants also undergo MRI scans throughout the study.
SUBGROUP 4: Participants engage in walking self-practice routines using a mobile app over 30 minutes daily for an additional 2 months and also engage in breathing self-practice routines using a mobile app over 30 minutes daily for 2 months on study. Participants may also participate in in-person group walking session with other participants weekly on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants also undergo MRI scans throughout the study.
STUDY 2: Cancer patients and their caregivers engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants also undergo MRI scans throughout the study.
STUDY 3: MS patients engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. At month 4, participants are randomized to 1 of 2 subgroups.
SUBGROUP 5: MS patients engage in breathing self-practice routines using a mobile app over 30 minutes daily for an additional 2 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Patients also undergo MRI scans and blood sample collection throughout the study.
SUBGROUP 6: MS patients discontinue breathing self-practice routines for the additional 2 months on study. Patients also undergo MRI scans and blood sample collection throughout the study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Study 1 Group 1, Subgroup 1 (6 month breathing sessions)
Participants engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants then engage in breathing self-practice routines using a mobile app over 30 minutes daily for an additional 2 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants also undergo MRI scans throughout the study.
Magnetic Resonance Imaging
Undergo MRI
Questionnaire Administration
Ancillary studies
Respiratory Therapy
Participate in breathing sessions
Study 1 Group 1, Subgroup 2 (4 month breathing sessions)
Participants engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants then discontinue breathing self-practice routines for the additional 2 months on study. Participants also undergo MRI scans throughout the study.
Magnetic Resonance Imaging
Undergo MRI
Questionnaire Administration
Ancillary studies
Respiratory Therapy
Participate in breathing sessions
Study 1 Group 2, Subgroup 3 (6 month walking routines)
Participants engage in walking self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may also participate in in-person group walking session with other participants weekly on study. Participants then engage in walking self-practice routines using a mobile app over 30 minutes daily for an additional 2 months on study. Participants may also participate in in-person group walking session with other participants weekly on study. Participants also undergo MRI scans throughout the study.
Exercise Intervention
Participate in walking routines
Magnetic Resonance Imaging
Undergo MRI
Questionnaire Administration
Ancillary studies
Study 1 Group 2, Subgroup 4 (walking + breathing)
Participants engage in walking self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may also participate in in-person group walking session with other participants weekly on study. Participants then engage in walking self-practice routines using a mobile app over 30 minutes daily for an additional 2 months and also engage in breathing self-practice routines using a mobile app over 30 minutes daily for 2 months on study. Participants may also participate in in-person group walking session with other participants weekly on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants also undergo MRI scans throughout the study.
Exercise Intervention
Participate in walking routines
Magnetic Resonance Imaging
Undergo MRI
Questionnaire Administration
Ancillary studies
Respiratory Therapy
Participate in breathing sessions
Study 2 (4 month breathing sessions)
Cancer patients and their caregivers engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Participants also undergo MRI scans throughout the study.
Magnetic Resonance Imaging
Undergo MRI
Questionnaire Administration
Ancillary studies
Respiratory Therapy
Participate in breathing sessions
Study 3 Subgroup 5 (6 month breathing sessions)
MS patients engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. MS patients then engage in breathing self-practice routines using a mobile app over 30 minutes daily for an additional 2 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. Patients also undergo MRI scans and blood sample collection throughout the study.
Biospecimen Collection
Undergo blood sample collection
Magnetic Resonance Imaging
Undergo MRI
Questionnaire Administration
Ancillary studies
Respiratory Therapy
Participate in breathing sessions
Study 3 Subgroup 6 (4 months breathing sessions)
MS patients engage in breathing self-practice routines using a mobile app over 30 minutes daily for 4 months on study. Participants may participate in real-time online breathing sessions with instructors weekly on study. Participants may also participate in in-person breathing sessions with instructors monthly on study. MS patients then discontinue breathing self-practice routines for the additional 2 months on study. Patients also undergo MRI scans and blood sample collection throughout the study.
Biospecimen Collection
Undergo blood sample collection
Magnetic Resonance Imaging
Undergo MRI
Questionnaire Administration
Ancillary studies
Respiratory Therapy
Participate in breathing sessions
Interventions
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Biospecimen Collection
Undergo blood sample collection
Exercise Intervention
Participate in walking routines
Magnetic Resonance Imaging
Undergo MRI
Questionnaire Administration
Ancillary studies
Respiratory Therapy
Participate in breathing sessions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* STUDY 1: Should read and understand English well enough to consent, complete measures, and follow instructions.
* STUDY 1: Must have access to a smartphone or tablet.
* STUDY 2: Participants must be physically fit enough to perform light exercise.
* STUDY 2: Cancer patients may have prostate cancer, neuroendocrine tumor, or brain cancer in any stage.
* STUDY 2: The main focus is on pairs of cancer patients and their respective caregivers, but individual cancer patients or individual caregivers are also acceptable.
* STUDY 2: Participants should read and understand English well enough to consent, complete measures, and follow instructions.
* STUDY 2: They also must have access to a smartphone or tablet.
* STUDY 3: Participants must be physically fit enough to perform light exercise.
* STUDY 3: The patient should have multiple sclerosis.
* STUDY 3: Participants should read and understand English well enough to consent, complete measures, and follow instructions.
* STUDY 3: They also must have access to a smartphone or tablet.
Exclusion Criteria
* STUDY 1: Additionally, those with chronic medical conditions, including heart disease (coronary artery disease, congestive heart failure, hypertension, cardiac arrhythmia), chronic obstructive pulmonary disease (COPD), cystic fibrosis, cancer, diabetes, sleep apnea, aneurysms, and neurological conditions (epilepsy, Alzheimer's disease, Huntington' disease, essential tremor and Parkinson disease) are excluded.
* STUDY 1: Participants with psychiatric conditions such as psychosis, suicidality, bipolar disorder, major depression, and substance use disorders are excluded.
* STUDY 1: Participants serving as caregivers for any of the aforementioned conditions and for other illnesses such as cancer or neurological disorders, are also excluded.
* STUDY 1: Further exclusions apply to those with severe vision, hearing impairments, have a body mass index (BMI) over 30, and those who are pregnant.
* STUDY 1: Those planning to become pregnant during the study period will be excluded.
* STUDY 2: Participants incompatible with MRI machines due to factors such as pacemakers or metallic implants are excluded, as are those with chronic lung disease (chronic obstructive pulmonary disease \[COPD\], cystic fibrosis), aneurysms, and those who are pregnant.
* STUDY 2: Those planning to become pregnant during the study period will be excluded.
* STUDY 3: Participants incompatible with MRI machines due to factors such as pacemakers or metallic implants are excluded, as are those with chronic lung disease (chronic obstructive pulmonary disease \[COPD\], cystic fibrosis), aneurysms, and those who are pregnant.
* STUDY 3: Those planning to become pregnant during the study period will be excluded.
18 Years
85 Years
ALL
Yes
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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Principal Investigators
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Paul H. Min, PhD
Role: PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester
Locations
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Mayo Clinic in Rochester
Rochester, Minnesota, United States
Countries
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Central Contacts
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Facility Contacts
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Clinical Trials Referral Office
Role: primary
Related Links
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Mayo Clinic Clinical Trials
Other Identifiers
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NCI-2025-00205
Identifier Type: REGISTRY
Identifier Source: secondary_id
24-000979
Identifier Type: OTHER
Identifier Source: secondary_id
24-000979
Identifier Type: -
Identifier Source: org_study_id