Clinical trial NCT06788886: Breathing Practice for Brain and Mental Health in Cancer and Neurodegenerative Diseases
Official title: Enhancing Brain and Mental Health Through Respiratory Training: Clinical Applications in Cancer and Neurodegenerative Disease Care for Patients and Caregivers (Breathing Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malignant Brain Neoplasm
Malignant Solid Neoplasm
Multiple Sclerosis
Neuroendocrine Tumor
Prostate Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2025-01-23
Enrollment: 147
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in respiratory function correlated with brain activity
timeFrame: Baseline up to 6 months
Secondary outcomes:
measure: Change in QOL - PHQ-9
timeFrame: Baseline up to 6 months
measure: Change in QOL - GAD-7
timeFrame: Baseline up to 6 months
measure: Change in QOL - Linear Analog Self Assessment
timeFrame: Baseline up to 6 months
measure: Adherence to the breathing protocol for the intention group
timeFrame: Up to 6 months
measure: Change in sleep quality - PSQI
timeFrame: Baseline up to 6 months
measure: Change in sleepiness - ESS
timeFrame: Baseline up to 6 months
measure: Change in fatigue - MFIS
timeFrame: Baseline up to 6 months
measure: Change in caregiver strain - CSI
timeFrame: Baseline up to 6 months
measure: Change in resilience - BRS
timeFrame: Baseline up to 6 months
measure: Change in ability to implement health-promoting behaviors - SRAHP
timeFrame: Baseline up to 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Paul H. Min, PhD
role: PRINCIPAL_INVESTIGATOR
References: