Cranial electrotherapy plus group life coaching for burnout in oncology healthcare workers
A Pilot Study Using a Cranial Electrotherapy Stimulation (CES) Device in Conjunction With Life Coaching to Alleviate Burnout Symptoms in HealthCare Workers (HCWs)
This project will test whether daily cranial electrotherapy stimulation combined with group life coaching can reduce burnout and moral distress and improve resilience and job retention for patient-facing oncology healthcare workers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 21 Years to 75 Years |
| Sex | All |
| Sponsor | Roswell Park Cancer Institute Academic / other |
| Locations | 1 site (Buffalo, New York) |
| Trial ID | NCT06977503 on ClinicalTrials.gov |
What this trial studies
This randomized crossover study gives patient-facing oncology staff either an active cranial electrotherapy stimulation (CES) device or a sham device for six weeks while they participate in three virtual group life coaching sessions and related video assignments. After a one-week device exchange, participants switch to the alternate device for a second six-week period. Outcomes are self-reported measures of burnout, moral distress, resilience, and organizational retention collected at baseline, midpoint, and study end. The trial is conducted at Roswell Park on the Buffalo-Niagara Medical Campus and requires daily one-hour device use and attendance at scheduled visits and coaching sessions.
Who should consider this trial
Good fit: Ideal participants are patient-facing healthcare workers aged 21–75 who work on the Buffalo-Niagara Medical Campus, report burnout on the Mini-Z II item, can attend three in-person Roswell Park visits, join virtual coaching sessions, and use the CES device daily for one hour.
Not a fit: Those unlikely to benefit include staff who do not have burnout symptoms, cannot commit to daily device use or scheduled visits/coaching, work off the Buffalo-Niagara Medical Campus, or otherwise cannot comply with the protocol requirements.
Why it matters
Potential benefit: If successful, the combined CES and life coaching approach could lower burnout and moral distress and improve resilience and employee retention among oncology healthcare workers.
How similar studies have performed: Prior small trials have shown CES can reduce symptoms like anxiety and insomnia and life coaching can improve resilience skills, but combining CES with group life coaching for clinician burnout is a novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 21 ≤ and ≤ 75 years old * Patient-facing healthcare workers (e.g., medical doctor, advanced practice provider, nurse) * Experiencing symptoms of burnout, as defined by a score of 1, 2, or 3 on question #2 of the Mini-Z II Survey * Working on the Buffalo-Niagara Medical Campus (e.g. Roswell Park, Oishei Children's Hospital, Buffalo General, etc.) * Ability to attend three (3) in-person appointments, one (1) hour in duration, at Roswell Park at week 1, week 6 and week 12 corresponding to the initial, midpoint, and final assessments * Ability to use the CES daily for an hour each day * Although the device is water-resistant, participants must agree to not use the device in the bath or shower * Ability to read and write in English * Participant has access to a computer with internet access and an email address * Ability to attend three (3) virtual 60-minute group life coaching sessions, via Zoom * Ability to complete three (3) 10-15-minute pre-recorded video assignments, which will be distributed via email (each assignment will be due by the end of the week that they are distributed) * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure Exclusion Criteria: * Subjects who self-report as pregnant or nursing. Pregnancy be verified with a urine test for all persons of childbearing potential with a uterus * Subjects with a self-reported history of the following: Meniere's disease, history of vertigo or prone to dizziness, seizure disorder, pacemaker / implantable cardioverter-defibrillator (automatic implantable cardioverter defibrillator \[AICD\]), cochlear implant, or any implanted electrical devices that cannot be shut off * Inability to tolerate the required minimum stimulation amplitude (200 uA) during the initial device training at the baseline visit. * Any self-reported medical or psychiatric condition which in the PI or study physician's opinion deems the participant an unsuitable candidate to participate in this trial. * Unwilling or unable to follow protocol requirements
Where this trial is running
Buffalo, New York
- Roswell Park Cancer Institute — Buffalo, New York, United States (Recruiting)
Study contacts
- Principal investigator: Amy Gallagher, PsyD — Roswell Park Cancer Institute
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.