Normal VolunteerNCT03212417
Education as an Intervention of Compassion Fatigue
A study testing Educational intervention in people with Normal Volunteer, run by City of Hope Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the impact education has on reducing compassion fatigue in Oncology Clinical Research Nurses. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Normal Volunteer
- What is being tested?
- Educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jul 2017to 17 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
City of Hope Medical Center
Duarte, California, 91010
About this study
Official title: Pilot/Feasibility Study of a Compassion Fatigue Education Intervention in Hematology/Oncology Clinical Research Nurses (CRNs) and Bone Morrow Transplant (BMT) Nurses
The purpose of this study is to evaluate the impact education has on reducing compassion fatigue in Oncology Clinical Research Nurses.
Read the 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.
- Conditions
- Normal Volunteer
- Being tested
- Educational intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionOther
Presentation of risk factors, signs and symptoms, and interventions on compassion fatigue
| Study group | Role | What they receive |
|---|---|---|
| Interventional trial without phases-supportive care. | Other | 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. Receives: Other: Educational intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation in intervention (Yes/No)
Measured: 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.
Measured: Three months post intervention
Secondary outcomes (5)
Descriptive analysis on participant's data collected by demographic information form, including
- Age (categorical, number of participants and percentage):
- Gender (categorical, number of participants and percentage):
- Years of RN (categorical, number of participants and percentage):
- Years of Clinical Research Nurse or Bone Marrow Transplant nurse (categorical, number of participants and percentage):
- Years of RN at COH (categorical, number of participants and percentage):
- Years of oncology RN (categorical, number of participants and percentage):
- Highest level of nursing education (categorical, number of participants and percentage)
- Ethnicity (categorical, number of participants and percentage)
- Religious preference (categorical, number of participants and percentage)
- Annual household income (categorical, number of participants and percentage)
- Marital status (categorical, number of participants and percentage)
Measured: 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.
Measured: From intervention to two-month post intervention
Calculate the changes of ProQol score from intervention to one-month post intervention
Measured: From intervention to one-month post intervention
Calculate the changes of ProQol score from intervention to two-month post intervention
Measured: 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
Measured: From intervention to three-month post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start6 Jul 2017
- Primary completion17 Jul 2019
- Study completion17 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal VolunteerStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lynette Svingen, MBA/MHA, RN, BSN, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212417
- Sponsor's protocol ID
- 17181
- Status last verified
- Oct 2026
- First submitted
- 29 Jun 2017
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot/Feasibility Study of a Compassion Fatigue Education Intervention in Hematology/Oncology Clinical Research Nurses (CRNs) and Bone Morrow Transplant (BMT) Nurses
- ClinicalTrials.gov ID
- NCT03212417
- Acronym / sponsor ID
- 17181
- Conditions
- Normal Volunteer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 17 Jul 2019 (actual)
- Study completion
- 17 Jul 2019 (actual)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the impact education has on reducing compassion fatigue in Oncology Clinical Research Nurses.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional trial without phases-supportive care. | Other | Other: Educational interventionThis 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational interventionPresentation of risk factors, signs and symptoms, and interventions on compassion fatigue | Other | Interventional trial without phases-supportive care. |
Primary outcome
Participation in intervention (Yes/No)
Time frame: 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
5 secondary outcomes
Descriptive analysis on participant's data collected by demographic information form, including
Time frame: 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
Calculate the changes of ProQol score from intervention to one-month post intervention
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynette Svingen, MBA/MHA, RN, BSN principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention in people with Normal Volunteer, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation in intervention (Yes/No) (time frame: Two months post intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.