- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03212417
Education as an Intervention of Compassion Fatigue
Pilot/Feasibility Study of a Compassion Fatigue Education Intervention in Hematology/Oncology Clinical Research Nurses (CRNs) and Bone Morrow Transplant (BMT) Nurses
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Slatten, Carson, and Carson (2011) describe compassion fatigue as "an occupational hazard for those in the helping professions and is a natural consequence of working with people who have experienced extremely stressful events" (p. 327). Compassion fatigue (CF) is a condition that can affect one's physical, emotional, and social well-being. CF can exist or be misunderstood as burnout, defined as the "inability to cope with job stress, displays symptoms such as emotional exhaustion, and reduced personal and professional accomplishments" (Maslach, Schaufeli, & Leiter, 2001). The term Secondary Traumatic stress has been used within the literature to describe nurses' exposure to the traumatic situations of patients and is often used interchangeably with compassion fatigue (Beck, 2011; Flarity, Gentry, & Mesinkoof, 2013), but is contrasted by compassion satisfaction (CS): the pleasure that nurses derive from the ability to perform work well (Stamm, 2009). Slatten et al., (2011) described compassion fatigue as a natural consequence of nursing: therefore, prevention of exposure should not be the focus of any intervention. The Literature review has identified that nurses should be educated about risk factors and coping strategies to combat compassion fatigue.
Neville and Cole (2013) describe incentives for organizations to proactively prevent CF, they explained:
The care patients receive from nurses is one of the most significant predictors of patient satisfaction and is a quality indicator of overall healthcare performance. Research demonstrates that nurses' perception of work environment and patient satisfaction are highly correlated; thus, measures to enhance nurses' ability to deliver excellent care and to thrive in their work environments are of paramount importance to healthcare institutions (p. 349).
Most patients on clinical trials have tried standard of care treatment unsuccessfully. Little is known, due to the lack of research, demonstrating the impact of CF, CS or Burnout on CRNs and BMT Nurses. Both nursing populations' work closely with oncology patients, either during or following participation on a clinical trial, developing a close relationship with the patients and their families. The nurses are at risk for exposure to emotionally disturbing patient outcomes that can be detrimental on psychological health. One-third of the Hematology and Solid Tumor clinical trials at City of Hope National Medical Center are phase 1 trials, which are to determine dose limiting toxicity with the intent of improving patient outcomes. Nurses are providing patient care to individuals with a poor prognosis, after repeat exposure to emotional pain, the CRN and BMT Nurse leave the organization due to intolerance of suffering.
This project is important to teach nurses how to recognize and manage CF. The educational intervention could reduce nurse turnover, increase morale, and improve patient satisfaction, all of which could be a cost savings to the organization.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Duarte, California, United States, 91010
- City of Hope Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Documented written informed consent of participant
- Must be a Clinical Research Nurse working in the Clinical Trials Office or a Bone Marrow Transplant nurse working at COH National Medical Center
- Ability read and speak English, (questionnaires are in English)
- Willingness and ability to complete three ProQol 5 surveys, one demographic survey,and Coping Mechanisms survey (cohort 2).
- Willingness to participate in a 30-minute educational intervention.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Interventional trial without phases-supportive care.
This is a feasibility pilot study project assessing the presence of compassion fatigue in clinical research nurses (cohort 1) and bone marrow transplant nurses (cohort 2).
A survey will be completed by participants prior to and after an educational presentation.
The intervention includes the risk factors, signs and symptoms, and interventions on compassion fatigue.
The survey will be completed prior to the education, immediately following the education, one month following the education and two months following the education.
A final survey will be implemented for the cohort 2 only.
The objective of this concluding analysis is to gather data relative to CF and coping mechanisms.
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Presentation of risk factors, signs and symptoms, and interventions on compassion fatigue
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Participation in intervention (Yes/No)
Time Frame: Two months post intervention
|
Two months post intervention
|
Participation in intervention and ProQoL survey (Professional Quality of Life: Compassion and Satisfaction Fatigue Version 5) at one-month and two-month assessment (Yes/No) Coping Mechanisms survey.
Time Frame: Three months post intervention
|
Three months post intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Descriptive analysis on participant's data collected by demographic information form, including
Time Frame: Three months post intervention
|
|
Three months post intervention
|
Descriptive analysis (median and range) on participant's ProQol score collected by ProQol survey (Professional Quality of Life: Compassion and Satisfaction Fatigue Version 5) at the intervention, one-month, and two-month assessment.
Time Frame: From intervention to two-month post intervention
|
From intervention to two-month post intervention
|
|
Calculate the changes of ProQol score from intervention to one-month post intervention
Time Frame: From intervention to one-month post intervention
|
From intervention to one-month post intervention
|
|
Calculate the changes of ProQol score from intervention to two-month post intervention
Time Frame: From intervention to two-month post intervention
|
From intervention to two-month post intervention
|
|
Descriptive analysis (median and range) on participant's coping mechanisms score collected at the three-month post intervention
Time Frame: From intervention to three-month post intervention
|
From intervention to three-month post intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Lynette Svingen, MBA/MHA, RN, BSN, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 17181
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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