Breathlessness Patterns in Patients With Cancer, COPD and Heart Failure: an fMRI Feasibility Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University Hospital, Geneva
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Feasibility of the study
Study Overview
Brief Summary
Dyspnea that persists despite optimal pathophysiological treatment is defined as persistent dyspnea.
Currently all brain functional magnetic resonance imaging (fMRI) studies conducted to evaluate breathlessness have done so using healthy volunteers or have concentrated on acute breathlessness. Little is known about chronic breathlessness patterns and their modulation by different triggers. Furthermore, it is currently assumed in the palliative care literature that patients suffering from different advanced and progressive diseases such as cancer, heart failure (HF) or chronic obstructive pulmonary disease (COPD) have the same triggers, perceptions and neurological pathways and thus require the same treatments/interventions (i.e. opioids as first line symptomatic pharmacologic treatment). However, it is now known that patients belonging to different disease groups do not necessarily benefit from opioids.
Aim of the study To assess the feasibility of identifying dyspnea patterns in different life-limiting conditions and to evaluate the effect of immersive virtual reality (IVR) on dyspnea using patient-reported-outcomes (PROMs).
Study procedure:
Patients with advanced chronic diseases such as cancer, COPD or HF suffering from dyspnea will undergo a brain fMRI in combination with an IVR intervention. The fMRI data will be reviewed to identify different patterns of dyspnea and the effect of IVR on dyspnea will be assessed through PROMs. Patients will be asked about the perceived burden of the study.
Detailed Description
Dyspnea that persists despite optimal pathophysiologic treatment is defined as persistent dyspnea.
Breathlessness, also defined as dyspnea, is a frequent symptom in patients with advanced and progressive diseases such as cancer, chronic obstructive pulmonary disease (COPD) and advanced heart failure (HF). In affected patients, breathlessness causes substantial suffering and is a major contributor to decreased quality of life.
Despite increasingly controversial data on the effectiveness of opioids in advanced disease, they are often prescribed according to expert opinion. It can be hypothesized that breathlessness is conveyed by a variety of different pathophysiologies resulting in various patterns of the central nervous system (CNS) signalling, requiring more than a one-size-fits-all answer to pharmacologic interventions (i.e. opioids).
In recent years, the healthcare industry has seen the development of immersive virtual reality therapies (IVR), also called "digital therapeutics". Immersive virtual reality is an interactive computer simulation that allows a person to be completely immersed within a three-dimensional virtual environment so that it has a real feeling of being in the virtual world. IVR has been used during magnetic resonance imaging (MRI), to reduce stress and anxiety perceived by patients who suffer from claustrophobia.
Functional MRI (fMRI) measures brain activity by detecting changes associated with blood flow. Studies conducted to evaluate breathlessness have done so using healthy volunteers, focusing on acute breathlessness or in the context of pulmonary rehabilitation. Little is known about persistent breathlessness patterns and their modulation by different triggers.
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age ≥ 18 years and
- •Followed by the outpatient palliative care clinic of the Geneva University Hospitals, Switzerland (HUG) and
- •Breathlessness at rest > 2 and < 8 on the NRS (numeric rating scale 0 to 10) and
- •Persistent breathlessness (persistent dyspnea for > 3 weeks despite adequate and maximal medication according to the pathology) and
- •In a stable clinical condition, i.e., without an episode of acute cardiac, respiratory, and/or neurological failure leading to hospitalization in the previous 4 weeks and
- •Diagnosis of either HF stage NYHA III-IV, or COPD with dyspnea on the modified MRC scale grade 3-4, or oncological disease with primary or secondary pulmonary involvement
- •Inclusion Criteria for Healthy Volunteers (Control Group)
- •Age ≥ 18 years and
- •No respiratory symptoms: dyspnea, cough, wheezing and
- •No known pulmonary, cardiac, or oncological disease and
- •Smoking status < 10 pack-years and
- •No contraindication to fMRI (Appendix 3) and
- •Ability to lie flat (supine position) and
- •No diagnosed psychiatric illness (severe depression, severe anxiety, psychosis, other) or antipsychotic treatment deemed a contraindication for fMRI based on physician judgement and
- •No neurological disorders according to neurological assessment, including diagnosed dementia (frontotemporal dementia, Alzheimer's disease, etc.), brain pathology (tumor, stroke, Parkinson's disease, etc.), or epilepsy and
- •No claustrophobia, acrophobia, photophobia, severe hearing loss, and/or severe visual deficit and
- •No contraindication to IVR (migraines, photosensitive epilepsy, vertigo)
Exclusion Criteria
- •Breathlessness at rest ≥ 8 on the NRS (numeric rating scale 0 to 10)
- •Contraindication to fMRI
- •Inability to lie flat (supine position)
- •Diagnosed psychiatric illness (severe depression, severe anxiety, psychosis, other) or antipsychotic treatment deemed a contraindication for fMRI based on physician judgement
- •Neurological disorders according to neurological assessment, including diagnosed dementia (frontotemporal dementia, Alzheimer's disease, etc.), brain pathology (tumor, stroke, Parkinson's disease, etc.), or epilepsy
- •Presence of claustrophobia, acrophobia, photophobia, severe hearing loss, and/or severe visual deficit
- •Contraindication to IVR (migraines, photosensitive epilepsy, vertigo)
Arms & Interventions
Participants
Patients and healthy volunteers who will have a cerebral fMRI
Intervention: Cerebral fMRI (Other)
Participants
Patients and healthy volunteers who will have a cerebral fMRI
Intervention: Immersive virtual reality (Other)
Outcomes
Primary Outcomes
Feasibility of the study
Time Frame: 18 months after the beginning of the study
Composite outcomes: 1. Recruitment rate: proportion of eligible patients who consent to participate, calculated as the number of participants enrolled divided by the total number of eligible patients approached during the recruitment period. A recruitment rate ≥ 50% will be considered feasible. 2. Retention rate: proportion of enrolled participants who complete the planned intervention (fMRI, vital signs, and study-associated questionnaires). A retention rate ≥ 70% will be considered acceptable. If both thresholds are met (recruitment rate and retention rate), progression to a larger observational study will be considered.
Secondary Outcomes
- Acceptability(15 minutes after the procedure)
- Evolution of vital parameters(Pre, during and 15 minutes after the fMRI)
- Evolution of dyspnea(Before, during and 15 minutes after the fMRI)
- Claustrophobia questionnaire(15 minutes after the procedure)
- Evolution of vital parameters(Before, during and 15 minutes after the fMRI)
- Evolution of vital parameters(Pre and 15 minutes after the fMRI)
Investigators
Lisa Hentsch
Doctor
University Hospital, Geneva