Recruiting

Life Coaching & CES

Sponsor:

Roswell Park Cancer Institute

Code:

NCT06977503

Conditions

Psychiatric Disorder

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

Cranial Electrical Stimulation (CES)

Discussion

Health and Wellness Coach

Informational Intervention

Sham Intervention

Study Details

Brief summary:

This clinical trial evaluates the effect of life coaching together with Cranial Electrotherapy Stimulation (CES) as an intervention to decrease self-reported symptoms of burnout, moral distress, resilience, and employee retention in oncology healthcare workers. Burnout and moral distress are occupational hazards for oncology healthcare workers. Emotional exhaustion, depersonalization, and lack of personal accomplishment at work are symptoms of burnout. Moral distress may be defined as knowing the right thing to do but being unable to do so based upon internal or external constraints. The device is attached to the earlobes that uses cranial electrotherapy stimulation (CES) at a microcurrent to alleviate symptoms of anxiety, insomnia, pain, and possibly depression. Life coaching is partnering with clients in a thought-provoking and creative process that inspires them to maximize their personal and professional potential and can increase resiliency skills such as boundary setting and prioritizing, increases in self-compassion and self-care, and potentially indirectly positively impact patient care. Undergoing the use of CES via the CES device, coupled with life coaching, may help alleviate burnout symptoms and moral distress in oncology healthcare workers.

Conditions

Psychiatric Disorder

Study ID

NCT06977503

Start date

Feb 4, 2026

Status verified date

Sep, 2026

Completion date

Oct 4, 2027

Anticipated

Primary completion date

Oct 4, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

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
  • Ability to attend three (3) in-person appointments, one (1) hour in duration, at Roswell Park at week 1, week 6 and week 15 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 occuring Mondays at 6:30pm EST, 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Cohort 1- Arm 1 (Cranial Electrotherapy Stimulation (CES) + life coaching)

Devices received during week 1. During weeks 2-7, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study. Participants also participate in virtual group life coaching sessions and discussions during weeks 3, 5, and 7 and view video assignments 3 times during weeks 2,4 and 6. Participants cross-over and exchange their device at week 8 . During weeks 9-14 participants cross-over and use the sham device QD over 1 hour 5 days per week for 6 weeks on study.

sham comparator: Cohort 1 -Arm II (Sham device + life coaching sessions)

Devices received during week 1. During weeks 2-7, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study. Participants also participate in virtual group life coaching sessions and discussions during weeks 3, 5, and 7 and view video assignments 3 times during weeks 2, 4 and 6.. At week 8 participants cross over and exchange their device and receive their second device. During weeks 9-14, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study.

experimental: Cohort 2 - Arm III - CES device + life coaching sessions

Participants receive their devices during week 9. During weeks 10-15, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 11, 13, and 15 and view video assignments 3 times during weeks 10, 12, and 14. Participants cross-over and exchange their devices at week 16. During weeks 7-22, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study.

sham comparator: Cohort 2 - Arm IV (Sham device + life coaching sessions

Participants receive their devices during week 9. During weeks 10-15, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 11, 13, and 15 and view video assignments 3 times during weeks 10, 12, and 14. Participants cross-over and exchange their devices at week 16. During weeks 7-22, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study

experimental: Cohort 3, Arm V (CES device + life coaching sessions)

Participants receive their devices during week 17. During weeks 18-23, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 19, 21, and 23 and view video assignments 3 times during weeks 18, 20, and 22. Participants cross-over and exchange their devices at week 24. During weeks 25-30, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study

sham comparator: Cohort 3, Arm VI (Sham-device + life coaching sessions)

Participants receive their devices during week 17. During weeks 18-23, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 19, 21, and 23 and view video assignments 3 times during weeks 18, 20, and 22. Participants cross-over and exchange their devices at week 24. During weeks 25-30, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study.

experimental: Cohort 4, Arm VII (CES device + life coaching sessions)

Participants receive their devices during week 25. During weeks 26-31, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 27, 29, and 31 and view video assignments 3 times during weeks 26, 28, and 30. Participants cross-over and exchange their devices at week 32. During weeks 33-38, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study.

sham comparator: Cohort 4, Arm VIII (Sham device + life coaching sessions)

Participants receive their devices during week 25. During weeks 26-31, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 27, 29, 31 and view video assignments 3 times during weeks 26, 28, 30. Participants cross-over and exchange their devices at week 32. During weeks 33-38, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study.

Interventions

Cranial Electrical Stimulation (CES)

Use CES device

Discussion

Participate in discussions

Health and Wellness Coach

Undergo coaching sessions

Informational Intervention

View video assignments

Sham Intervention

Undergo sham intervention

Primary outcome measure

  • Symptoms of burnout in healthcare workers (HCWs) [ Time Frame: At baseline, 8 weeks, and 15 weeks ]
  • Symptoms of moral distress in HCWs [ Time Frame: At baseline, 8 weeks, and 15 weeks ]

Central Contacts and Locations

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Amy Gallagher, PsyD

716-845-7399Amy.Gallagher@roswellpark.org

Principal Investigator:

Amy Gallagher

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2026-09-09.