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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-03017 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I-3956824 | Other Identifier | Roswell Park Cancer Institute |
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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.
PRIMARY OBJECTIVE:
I. To determine the efficacy of using Cranial Electrotherapy Stimulation (CES) with group life coaching sessions as an intervention to decrease healthcare worker self-reported symptoms of burnout and moral distress.
SECONDARY OBJECTIVE:
I. To determine the efficacy of using Cranial Electrotherapy Stimulation (CES) with group life coaching sessions as a supportive intervention to increase healthcare worker self-reported ratings of resilience, and employment retention (Organizational Wellbeing Assessment - Retention [OWA-R]).
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: During weeks 1-6, participants use the CES device once daily (QD) over 1 hour 5 days per week for 6 weeks on study. Participants also participate in virtual group life coaching sessions and discussions and view video assignments 3 times during weeks 1, 3, and 6. At week 7, participants exchange device for second device. During weeks 8-13, participants cross-over and use the sham device QD over 1 hour 5 days per week for 6 weeks on study.
ARM II: During weeks 1-6, 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 and view video assignments 3 times during weeks 1, 3, and 6. At week 7, participants exchange device for second device. During weeks 8-13, participants cross-over and use the CES device QD over 1 hour 5 days per week for 6 weeks on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Cranial Electrotherapy Stimulation (CES) + life coaching) | Experimental | During weeks 1-6, 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 and view video assignments 3 times during weeks 1, 3, and 6. At week 7 participants will return their devices and receive their second device . During weeks 8-13 participants cross-over and use the sham device QD over 1 hour 5 days per week for 6 weeks on study. |
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| Arm II (Sham device + life coaching sessions) | Sham Comparator | During weeks 1-6, 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 and view video assignments 3 times during weeks 1, 3, and 6. At week 7, participants return their device and receive their second device. During weeks 8-13, participants cross-over and use the CES device QD over 1 hour 5 days per week for 6 weeks on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cranial Electrical Stimulation (CES) | Procedure | Use CES device |
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| Measure | Description | Time Frame |
|---|---|---|
| Symptoms of burnout in healthcare workers (HCWs) | Will be assessed using the Mini-Z Survey. Will be summarized by study arm and time-point (baseline, midpoint, and follow-up) using the appropriate descriptive statistics, and graphically using mean or dot plots. The Mini-Z scores will be modeled as a function of study arm, time-point, their two-way interaction, and random cohort and subject (nested within cohort) effects using linear mixed models (LMMs). | At baseline, 6 weeks, and 13 weeks |
| Symptoms of moral distress in HCWs | Will be assessed using the Measure of Moral Distress for Healthcare Workers (MMDHW). Will be summarized by study arm and time-point (baseline, midpoint, and follow-up) using the appropriate descriptive statistics, and graphically using mean or dot plots. The MMDHW scores will be modeled as a function of study arm, time-point, their two-way interaction, and random cohort and subject (nested within cohort) effects using LMMs. | At baseline, 6 weeks, and 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported resilience in HCWs | Measure of resilience will be assessed using the Brief Resilient Coping Scale. Will be summarized by study arm and time-point (baseline and follow-up) using the appropriate descriptive statistics, and graphically using mean or dot plots. Will be modeled as a function of study arm, time-point, their two-way interaction, and random cohort and subject (nested within cohort) effects using LMMs. |
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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
Ability to read and write in English
Participant has access to a computer with internet access and an email address
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:
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| Name | Affiliation | Role |
|---|---|---|
| Amy Gallagher, PsyD | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14263 | United States |
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Researchers will be blinded with respect to subjects' study number, pre/post assessment data, and CES group (e.g., Group A versus Group B), the participants will remain blinded to which device they received (either sham or investigational device) throughout the duration of the study.
| Discussion | Other | Participate in discussions |
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| Health and Wellness Coach | Behavioral | Undergo coaching sessions |
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| Informational Intervention | Other | View video assignments |
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| Sham Intervention | Procedure | Undergo sham intervention |
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| Survey Administration | Other | Ancillary studies |
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| At baseline, 6 weeks, and 13 weeks |
| HCW self-reported probability of employment retention | Likelihood of employment retention will be assessed using the Organizational Wellbeing Assessment - Retention. Will be summarized by study arm and time-point (baseline and follow-up) using the appropriate descriptive statistics, and graphically using mean or dot plots. Will be modeled as a function of study arm, time-point, their two-way interaction, and random cohort and subject (nested within cohort) effects using LMMs. | At baseline, 6 weeks, and 13 weeks |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D006262 | Health |
| ID | Term |
|---|---|
| D011154 | Population Characteristics |
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