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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-00205 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 24-000979 | Other Identifier | Mayo Clinic Institutional Review Board |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study 1 Group 1, Subgroup 1 (6 month breathing sessions) | Experimental | 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. |
|
| Study 1 Group 1, Subgroup 2 (4 month breathing sessions) | Experimental | 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. |
|
| Study 1 Group 2, Subgroup 3 (6 month walking routines) | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood sample collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in respiratory function correlated with brain activity | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in QOL - PHQ-9 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Paul H. Min, PhD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Study 1 Group 2, Subgroup 4 (walking + breathing) | Experimental | 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. |
|
| Study 2 (4 month breathing sessions) | Experimental | 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. |
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| Study 3 Subgroup 5 (6 month breathing sessions) | Experimental | 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. |
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| Study 3 Subgroup 6 (4 months breathing sessions) | Experimental | 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. |
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| Exercise Intervention | Other | Participate in walking routines |
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| Magnetic Resonance Imaging | Procedure | Undergo MRI |
|
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| Questionnaire Administration | Other | Ancillary studies |
|
| Respiratory Therapy | Procedure | Participate in breathing sessions |
|
| Change in QOL - GAD-7 |
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 | 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 | Up to 6 months |
| Change in sleep quality - PSQI | 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 | 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 | 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 | 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 | 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 | 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 |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D009103 | Multiple Sclerosis |
| D018358 | Neuroendocrine Tumors |
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D009682 | Magnetic Resonance Spectroscopy |
| D012138 | Respiratory Therapy |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D013812 | Therapeutics |
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