Breathing Practice for Brain and Mental Health in Cancer and Neurodegenerative Diseases
June 8, 2026 updated by: Mayo Clinic
Enhancing Brain and Mental Health Through Respiratory Training: Clinical Applications in Cancer and Neurodegenerative Disease Care for Patients and Caregivers (Breathing Study)
This clinical trial studies the effect of respiratory training for enhancing brain and mental health among patients with multiple sclerosis (MS) and cancer (along with their caregivers).
The relationship between respiration, cardiovascular effects in the brain, mental health, and neurophysiological mechanisms are significant for patient populations facing complex health challenges, such as those with cancer and neurodegenerative disease, and their caregivers.
By measuring oxygen delivery to brain tissues and cerebrospinal fluid flow, this trial may help researchers investigate the potential benefits of respiratory training for patients with MS and cancer and their caregivers.
Study Overview
Status
Recruiting
Conditions
Detailed Description
PRIMARY OBJECTIVE:
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.
Study Type
Interventional
Enrollment (Estimated)
147
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Principal Investigator:
- Paul H. Min, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- STUDY 1: Participants must be physically fit enough to perform light exercise.
- 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: Participants incompatible with MRI machines due to factors such as pacemakers or metallic implants.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
Ancillary studies
Undergo MRI
Other Names:
Participate in breathing sessions
|
|
Experimental: 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.
|
Ancillary studies
Undergo MRI
Other Names:
Participate in breathing sessions
|
|
Active Comparator: 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.
|
Ancillary studies
Undergo MRI
Other Names:
Participate in walking routines
|
|
Experimental: 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.
|
Ancillary studies
Undergo MRI
Other Names:
Participate in breathing sessions
Participate in walking routines
|
|
Experimental: 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.
|
Ancillary studies
Undergo MRI
Other Names:
Participate in breathing sessions
|
|
Experimental: 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.
|
Ancillary studies
Undergo MRI
Other Names:
Undergo blood sample collection
Other Names:
Participate in breathing sessions
|
|
Experimental: 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.
|
Ancillary studies
Undergo MRI
Other Names:
Undergo blood sample collection
Other Names:
Participate in breathing sessions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in respiratory function correlated with brain activity
Time Frame: Baseline up to 6 months
|
Assessed using advanced imaging techniques (such as MRI) and physiological analyses.
The approach to data analysis will involve a detailed examination of the MRI data collected from each participant.
Respiratory data will be correlated with neuroimaging findings to provide a comprehensive view of how respiratory patterns may influence brain activity.
|
Baseline up to 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in QOL - PHQ-9
Time Frame: Baseline up to 6 months
|
Assessed using the Patient Health Questionnaire-9 (PHQ-9).
The PHQ-9 consists of 9 questions related to problems experienced over the past 2 weeks.
Questions are answered on a scale of 0-3 where 0=Not at all; 1=several days; 2=more than half the days, and 3=nearly every day.
|
Baseline up to 6 months
|
|
Change in QOL - GAD-7
Time Frame: Baseline up to 6 months
|
Assessed using the Generalized Anxiety Disorder-7 (GAD-7).
The GAD-7 consists of 7 questions related to problems experienced over the past 2 weeks.
Questions are answered on a scale of 0-3 where 0=Not at all; 1=several days; 2=more than half the days, and 3=nearly every day.
|
Baseline up to 6 months
|
|
Change in QOL - Linear Analog Self Assessment
Time Frame: Baseline up to 6 months
|
Assessed using the Linear Analog Self Assessment, which consists of 5 questions related to feeling related to well being experienced over the past week.
Questions are answered on a scale ranging from 0-10 where 0=as bad as it can be and 10=as good as it can be.
|
Baseline up to 6 months
|
|
Adherence to the breathing protocol for the intention group
Time Frame: Up to 6 months
|
Up to 6 months
|
|
|
Change in sleep quality - PSQI
Time Frame: Baseline up to 6 months
|
Assessed using the Pittsburgh Sleep Quality Index (PSQI), which consists of questions related to sleep habits during the past month.
Questions begin with sleep habits (general time going to bed, how long to fall asleep, general rising time, etc.).
These are followed by a list of items answered on scale of 0-3 where 0=not during the past month; 1=less than once a week; 2=once or twice a week ;and 3=three or more times a week.
Higher scores indicate worse sleep quality.
|
Baseline up to 6 months
|
|
Change in sleepiness - ESS
Time Frame: Baseline up to 6 months
|
Assessed using the Epworth Sleepiness Scale (ESSI), which consists of questions related to sleep habits during the past month.
The survey consists of a list of eight situations in which the respondents rate their tendency to become sleepy on a scale of 0, no chance of dozing, to 3, high chance of dozing.
The scale estimates whether participants are experiencing excessive sleepiness, which higher scores indicating a higher level of sleepiness..
|
Baseline up to 6 months
|
|
Change in fatigue - MFIS
Time Frame: Baseline up to 6 months
|
Assessed using the Modified Fatigue Impact Scale (MFIS), which consists of 21 questions related to the effects of fatigue over the past 4 weeks.
Questions are answered on a scale of 0-4 where 0=never; 1=rarely; 2=sometimes; 3=often; and 4=almost always.
|
Baseline up to 6 months
|
|
Change in caregiver strain - CSI
Time Frame: Baseline up to 6 months
|
Assessed using the Caregiver Strain Index (CSI), a list of 13 "things that other people have found to be difficult."
Caregivers respond with yes or no to indicate whether each item applies to them.
|
Baseline up to 6 months
|
|
Change in resilience - BRS
Time Frame: Baseline up to 6 months
|
Assessed using the Brief Resilience Scale (BRS), which consists of 6 items answered on a scale of 1-5 where 1=strongly disagree; 2=disagree; 3=neutral; 4=agree, and 5=strongly agree (or the reverse, i.e. 5=strongly disagree and 1=strongly agree).
Higher scores generally indicate stronger resilience.
|
Baseline up to 6 months
|
|
Change in ability to implement health-promoting behaviors - SRAHP
Time Frame: Baseline up to 6 months
|
Assessed using the Self Rated Abilities for Health Practices Scale (SRAHP), a 28-item, 5-point scale.
SRAHP contains four subscales: Exercise, Nutrition, Responsible Health Practice, and Psychological Well Being.
Each subscale has seven items.
Respondents are asked to rate the extent to which they are able to perform health practices related to these four domains.
Responses are on a 5-point scale where 0=not at all; 1=a little; 2=somewhat; 3=mostly; and 4=completely.
Higher scores indicate greater self-efficacy for health practices.
|
Baseline up to 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Paul H. Min, PhD, Mayo Clinic in Rochester
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 5, 2025
Primary Completion (Estimated)
January 18, 2027
Study Completion (Estimated)
January 18, 2027
Study Registration Dates
First Submitted
January 17, 2025
First Submitted That Met QC Criteria
January 17, 2025
First Posted (Actual)
January 23, 2025
Study Record Updates
Last Update Posted (Actual)
June 10, 2026
Last Update Submitted That Met QC Criteria
June 8, 2026
Last Verified
June 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Autoimmune Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Prostatic Neoplasms
- Multiple Sclerosis
- Neuroendocrine Tumors
- Brain Neoplasms
- Investigative Techniques
- Therapeutics
- Clinical Laboratory Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Chemistry Techniques, Analytical
- Spectrum Analysis
- Specimen Handling
- Magnetic Resonance Spectroscopy
- Respiratory Therapy
Other Study ID Numbers
- 24-000979 (Other Identifier: Mayo Clinic Institutional Review Board)
- NCI-2025-00205 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.