Compassion FatigueNCT04372303
Effect of a Compassion Fatigue Resiliency Program
A study testing Compassion Fatigue Resiliency Program (CFRP) in people with Compassion Fatigue, run by Koc University Hospital.
Trial summary
This study aimed to conduct a short- and long-term Compassion Fatigue Resiliency Program and compare its impact on nurses' professional quality of life, perceived stress and resilience. The research was conducted between January 2017 and January 2019 as a randomized controlled trial. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Compassion Fatigue
- What is being tested?
- Compassion Fatigue Resiliency Program (CFRP)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- 8 Jan 2017to 8 Jan 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Nurses working in inpatient oncology-hematology, outpatient chemotherapy, or BMT unit Exclusion criteria
- Providing care for pediatric oncology patients
- Being a nurse manager
- Not providing direct patient care
Who cannot join
None listed.
About this study
Official title: Effect of a Compassion Fatigue Resiliency Program on Nurses' Professional Quality of Life, Perceived Stress, Resilience: A Randomized Controlled Trial
This study aimed to conduct a short- and long-term Compassion Fatigue Resiliency Program and compare its impact on nurses' professional quality of life, perceived stress and resilience. The research was conducted between January 2017 and January 2019 as a randomized controlled trial. The sample comprised 125 oncology-hematology nurses randomly assigned to a Experimental I (short-term Compassion Fatigue Resiliency Program), Experimental II (long-term Compassion Fatigue Resiliency Program) or control group. Data was collected using Personal Information Form, Professional Quality of Life Scale-IV (ProQOL-IV), Perceived Stress Scale, and Resilience Scale for Adults. Measurements were obtained during pre- and post-test and at three-, six- and twelve-month follow-ups. Research hypotheses were analyzed using multilevel models.
Read the detailed description
The research was conducted with nurses from the oncology-hematology inpatient services, outpatient chemotherapy units and bone marrow transplant (BMT) units of three private hospitals in Istanbul between January 2017 and January 2019. No sample selection models were applied, and out of 153 nurses working in these services, 125 nurses meeting the inclusion criteria were included in the study. Nurses were randomly assigned to the Experimental I, Experimental II, or control group in order to prevent interaction between the subjects working in the same hospital. Of the nurses, 34 completed the short-term program (Experimental I), 49 completed the long-term (Experimental II), and 42 were assigned to the control group.
Data collection: Data was collected using Personal Information Form, Professional Quality of Life Scale-IV (ProQOL-IV), Perceived Stress Scale, and Resilience Scale for Adults Study procedure This study's principal investigator had participated online in a CFRP, developed by Eric Gentry (Licensed Mental Health Counselor) (2002), and received the certificate, and then conducted the program with the nurses. Meetings were held with each institution's directorate of nursing services to determine the training schedules and content. The schedules were planned in accordance with the hospital administration's preferences and by taking nurses' busy schedules into consideration. Preliminary tests were applied to Experimental I, Experiment II, and the control group before the training. Experimental I received a short-term program (five hours per day for two days, ten hours in total) while Experimental II received a long-term one (five weeks, two hours per week, ten hours in total). No intervention was applied to the control group. After the training, a post-test, and three-, six-, and twelve-month follow-up assessments were conducted for all groups.
Program Compassion Fatigue Resiliency Program The purpose of the program: The purpose of the program is to provide oncology-hematology nurses with knowledge and skills that will increase their level of resilience by helping them recognize compassion fatigue, cope with its consequences and work effectively.
The objectives of the training program
Nurses, who successfully complete the program will be able to:
- Explain the historical development of compassion fatigue among caregivers,
- Define the developmental process of compassion fatigue,
- Specify the risk factors for compassion fatigue,
- Explain the symptoms of compassion fatigue,
- Raise awareness about their personal history,
- Explain the concept of stress and its impact on the body,
- Apply compassion fatigue resilience skills acquired in the program,
- Professionally create a self-directed resilience plan. Validity and reliability/Rigour The included scales have been tested for validity and reliability for various settings and countries. The investigators chose three private hospitals in Istanbul, which are considered to be close to each other, such as institution (etc. working conditions) and the sociodemographic and professional characteristics of nurses (etc. age, educational status, clinical experience, willingness to work in oncology, voluntarily career choice) that are known to affect dependent variables. Then, the investigators randomly assigned each hospital to the Experimental I, Experimental II, or control group in order to prevent interaction between the nurses working in the same hospital. Finally, the program was conducted by the principal investigator who had participated online in a CFRP, and received the certificate.
Data analysis: SPSS 25.0 software package was used to analyze data. A chi-square test and one-way ANOVA determined whether the scales and information on demographic characteristics and work environment differed among pre-initiative groups; in other words, to measure homogeneity. Variables found to be statistically significant were included in the model as a correction factor for primary hypotheses. Primary research hypotheses were analyzed using multilevel models (MLM). This analysis method has some advantages over others, such as repeated measures ANOVA.
- Conditions
- Compassion Fatigue
- Being tested
- Compassion Fatigue Resiliency Program (CFRP)
- Keywords
- Oncology-hematology nurses, compassion fatigue, burnout, compassion satisfaction, perceived stress, resilience
- Medical subject headings
- Compassion Fatigue, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compassion Fatigue Resiliency Program (CFRP)Behavioural
The purpose of Compassion Fatigue Resiliency Program (CFRP) is to provide oncology-hematology nurses with knowledge and skills that will increase their level of resilience by helping them recognize compassion fatigue, cope with its consequences and work effectively.
| Study group | Role | What they receive |
|---|---|---|
| Short-term Compassion Fatigue Resiliency Program | Experimental | Experimental I received a short-term program (five hours per day for two days, ten hours in total). Receives: Behavioral: Compassion Fatigue Resiliency Program (CFRP) |
| Long-term Compassion Fatigue Resiliency Program | Experimental | Experimental II received a long-term program (five weeks, two hours per week, ten hours in total). Receives: Behavioral: Compassion Fatigue Resiliency Program (CFRP) |
| Control | No intervention | No intervention was applied to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Professional Quality of Life Scale-IV (ProQoL), "change" is being assessed.
Professional Quality of Life Scale-IV (ProQoL): It is a self-reporting instrument consisting of thirty items and three subscales: Compassion Fatigue (CF), Sompassion Satisfaction (CS), and burnout. The scale has no total score. Each subscale is evaluated separately.
- Scores above 17 indicate high CF levels while scores below 8 indicate low,
- Scores below 18 indicate low burnout levels while scores above 27 indicate high
- Scores above 42 indicate high CS levels while those below 33 indicate low
Measured: Change from Baseline up to 1 year
Perceived Stress Scale, "change" is being assessed.
Perceived Stress Scale: The lowest possible score is 0 and the highest is 40. A high total score is considered a high level of perceived stress.
Measured: Change from Baseline up to 1 year
Resilience Scale for Adults, "change" is being assessed.
Resilience Scale for Adults: a lowest possible score of 33 and a highest of 165. A high total score is considered a high level of resilience.
Measured: Change from Baseline up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start8 Jan 2017
- Primary completion8 Jan 2019
- Study completion8 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Compassion FatigueStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koc University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba Pehlivan, Koc University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04372303
- Sponsor's protocol ID
- TPehlivan
- Status last verified
- Apr 2020
- First submitted
- 23 Apr 2020
- Last updated
- 4 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No, because hospitals told us, the investigators have to keep secret their nurses individual data.
Publications
Traeger L, Park ER, Sporn N, Repper-DeLisi J, Convery MS, Jacobo M, Pirl WF. Development and evaluation of targeted psychological skills training for oncology nurses in managing stressful patient and family encounters. Oncol Nurs Forum. 2013 Jul;40(4):E327-36. doi: 10.1188/13.ONF.E327-E336.
PubMed 23803277Tarantino B, Earley M, Audia D, D'Adamo C, Berman B. Qualitative and quantitative evaluation of a pilot integrative coping and resiliency program for healthcare professionals. Explore (NY). 2013 Jan-Feb;9(1):44-7. doi: 10.1016/j.explore.2012.10.002.
PubMed 23294820Deible S, Fioravanti M, Tarantino B, Cohen S. Implementation of an integrative coping and resiliency program for nurses. Glob Adv Health Med. 2015 Jan;4(1):28-33. doi: 10.7453/gahmj.2014.057.
PubMed 25694849Rushton CH, Batcheller J, Schroeder K, Donohue P. Burnout and Resilience Among Nurses Practicing in High-Intensity Settings. Am J Crit Care. 2015 Sep;24(5):412-20. doi: 10.4037/ajcc2015291.
PubMed 26330434Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
PubMed 6668417Friborg O, Barlaug D, Martinussen M, Rosenvinge JH, Hjemdal O. Resilience in relation to personality and intelligence. Int J Methods Psychiatr Res. 2005;14(1):29-42. doi: 10.1002/mpr.15.
PubMed 16097398Pehlivan T, Guner P. Effect of a compassion fatigue resiliency program on nurses' professional quality of life, perceived stress, resilience: A randomized controlled trial. J Adv Nurs. 2020 Dec;76(12):3584-3596. doi: 10.1111/jan.14568. Epub 2020 Oct 3.
PubMed 33009840Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.
PubMed 32627860
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Compassion Fatigue Resiliency Program on Nurses' Professional Quality of Life, Perceived Stress, Resilience: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04372303
- Acronym / sponsor ID
- TPehlivan
- Conditions
- Compassion Fatigue
- Keywords
- Oncology-hematology nurses, compassion fatigue, burnout, compassion satisfaction, perceived stress, resilience
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Koc University HospitalUniversity, hospital or other
- Study start
- 8 Jan 2017 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 8 Jan 2019 (actual)
- First posted
- 4 May 2020 (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.
This study aimed to conduct a short- and long-term Compassion Fatigue Resiliency Program and compare its impact on nurses' professional quality of life, perceived stress and resilience. The research was conducted between January 2017 and January 2019 as a randomized controlled trial. The sample comprised 125 oncology-hematology nurses randomly assigned to a Experimental I (short-term Compassion Fatigue Resiliency Program), Experimental II (long-term Compassion Fatigue Resiliency Program) or control group. Data was collected using Personal Information Form, Professional Quality of Life Scale-IV (ProQOL-IV), Perceived Stress Scale, and Resilience Scale for Adults. Measurements were obtained during pre- and post-test and at three-, six- and twelve-month follow-ups. Research hypotheses were analyzed using multilevel models.
Detailed description
The research was conducted with nurses from the oncology-hematology inpatient services, outpatient chemotherapy units and bone marrow transplant (BMT) units of three private hospitals in Istanbul between January 2017 and January 2019. No sample selection models were applied, and out of 153 nurses working in these services, 125 nurses meeting the inclusion criteria were included in the study. Nurses were randomly assigned to the Experimental I, Experimental II, or control group in order to prevent interaction between the subjects working in the same hospital. Of the nurses, 34 completed the short-term program (Experimental I), 49 completed the long-term (Experimental II), and 42 were assigned to the control group.
Data collection: Data was collected using Personal Information Form, Professional Quality of Life Scale-IV (ProQOL-IV), Perceived Stress Scale, and Resilience Scale for Adults Study procedure This study's principal investigator had participated online in a CFRP, developed by Eric Gentry (Licensed Mental Health Counselor) (2002), and received the certificate, and then conducted the program with the nurses. Meetings were held with each institution's directorate of nursing services to determine the training schedules and content. The schedules were planned in accordance with the hospital administration's preferences and by taking nurses' busy schedules into consideration. Preliminary tests were applied to Experimental I, Experiment II, and the control group before the training. Experimental I received a short-term program (five hours per day for two days, ten hours in total) while Experimental II received a long-term one (five weeks, two hours per week, ten hours in total). No intervention was applied to the control group. After the training, a post-test, and three-, six-, and twelve-month follow-up assessments were conducted for all groups.
Program Compassion Fatigue Resiliency Program The purpose of the program: The purpose of the program is to provide oncology-hematology nurses with knowledge and skills that will increase their level of resilience by helping them recognize compassion fatigue, cope with its consequences and work effectively.
The objectives of the training program
Nurses, who successfully complete the program will be able to:
- Explain the historical development of compassion fatigue among caregivers,
- Define the developmental process of compassion fatigue,
- Specify the risk factors for compassion fatigue,
- Explain the symptoms of compassion fatigue,
- Raise awareness about their personal history,
- Explain the concept of stress and its impact on the body,
- Apply compassion fatigue resilience skills acquired in the program,
- Professionally create a self-directed resilience plan. Validity and reliability/Rigour The included scales have been tested for validity and reliability for various settings and countries. The investigators chose three private hospitals in Istanbul, which are considered to be close to each other, such as institution (etc. working conditions) and the sociodemographic and professional characteristics of nurses (etc. age, educational status, clinical experience, willingness to work in oncology, voluntarily career choice) that are known to affect dependent variables. Then, the investigators randomly assigned each hospital to the Experimental I, Experimental II, or control group in order to prevent interaction between the nurses working in the same hospital. Finally, the program was conducted by the principal investigator who had participated online in a CFRP, and received the certificate.
Data analysis: SPSS 25.0 software package was used to analyze data. A chi-square test and one-way ANOVA determined whether the scales and information on demographic characteristics and work environment differed among pre-initiative groups; in other words, to measure homogeneity. Variables found to be statistically significant were included in the model as a correction factor for primary hypotheses. Primary research hypotheses were analyzed using multilevel models (MLM). This analysis method has some advantages over others, such as repeated measures ANOVA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Short-term Compassion Fatigue Resiliency Program | Experimental | Behavioral: Compassion Fatigue Resiliency Program (CFRP)Experimental I received a short-term program (five hours per day for two days, ten hours in total). |
| Long-term Compassion Fatigue Resiliency Program | Experimental | Behavioral: Compassion Fatigue Resiliency Program (CFRP)Experimental II received a long-term program (five weeks, two hours per week, ten hours in total). |
| Control | No intervention | –No intervention was applied to the control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Nurses working in inpatient oncology-hematology, outpatient chemotherapy, or BMT unit Exclusion criteria
- Providing care for pediatric oncology patients
- Being a nurse manager
- Not providing direct patient care
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 |
|---|---|---|
| Compassion Fatigue Resiliency Program (CFRP)The purpose of Compassion Fatigue Resiliency Program (CFRP) is to provide oncology-hematology nurses with knowledge and skills that will increase their level of resilience by helping them recognize compassion fatigue, cope with its consequences and work effectively. | Behavioural | Long-term Compassion Fatigue Resiliency Program, Short-term Compassion Fatigue Resiliency Program |
Primary outcome
Professional Quality of Life Scale-IV (ProQoL), "change" is being assessed.
Time frame: Change from Baseline up to 1 year
Professional Quality of Life Scale-IV (ProQoL): It is a self-reporting instrument consisting of thirty items and three subscales: Compassion Fatigue (CF), Sompassion Satisfaction (CS), and burnout. The scale has no total score. Each subscale is evaluated separately. * Scores above 17 indicate high CF levels while scores below 8 indicate low, * Scores below 18 indicate low burnout levels while scores above 27 indicate high * Scores above 42 indicate high CS levels while those below 33 indicate low
Perceived Stress Scale, "change" is being assessed.
Time frame: Change from Baseline up to 1 year
Perceived Stress Scale: The lowest possible score is 0 and the highest is 40. A high total score is considered a high level of perceived stress.
Resilience Scale for Adults, "change" is being assessed.
Time frame: Change from Baseline up to 1 year
Resilience Scale for Adults: a lowest possible score of 33 and a highest of 165. A high total score is considered a high level of resilience.
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 4 May 2020.
- Background: PubMed 23803277Traeger L, Park ER, Sporn N, Repper-DeLisi J, Convery MS, Jacobo M, Pirl WF. Development and evaluation of targeted psychological skills training for oncology nurses in managing stressful patient and family encounters. Oncol Nurs Forum. 2013 Jul;40(4):E327-36. doi: 10.1188/13.ONF.E327-E336.
- Background: PubMed 23294820Tarantino B, Earley M, Audia D, D'Adamo C, Berman B. Qualitative and quantitative evaluation of a pilot integrative coping and resiliency program for healthcare professionals. Explore (NY). 2013 Jan-Feb;9(1):44-7. doi: 10.1016/j.explore.2012.10.002.
- Background: PubMed 25694849Deible S, Fioravanti M, Tarantino B, Cohen S. Implementation of an integrative coping and resiliency program for nurses. Glob Adv Health Med. 2015 Jan;4(1):28-33. doi: 10.7453/gahmj.2014.057.
- Background: PubMed 26330434Rushton CH, Batcheller J, Schroeder K, Donohue P. Burnout and Resilience Among Nurses Practicing in High-Intensity Settings. Am J Crit Care. 2015 Sep;24(5):412-20. doi: 10.4037/ajcc2015291.
- Background: PubMed 6668417Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.
- Background: PubMed 16097398Friborg O, Barlaug D, Martinussen M, Rosenvinge JH, Hjemdal O. Resilience in relation to personality and intelligence. Int J Methods Psychiatr Res. 2005;14(1):29-42. doi: 10.1002/mpr.15.
- Derived from this study: PubMed 33009840Pehlivan T, Guner P. Effect of a compassion fatigue resiliency program on nurses' professional quality of life, perceived stress, resilience: A randomized controlled trial. J Adv Nurs. 2020 Dec;76(12):3584-3596. doi: 10.1111/jan.14568. Epub 2020 Oct 3.
- Derived from this study: PubMed 32627860Kunzler AM, Helmreich I, Chmitorz A, Konig J, Binder H, Wessa M, Lieb K. Psychological interventions to foster resilience in healthcare professionals. Cochrane Database Syst Rev. 2020 Jul 5;7(7):CD012527. doi: 10.1002/14651858.CD012527.pub2.
- Individual participant dataSharing planned: No. No, because hospitals told us, the investigators have to keep secret their nurses individual data.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Compassion Fatigue Resiliency Program (CFRP) in people with Compassion Fatigue, run by Koc University Hospital.
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 4 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 4 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Professional Quality of Life Scale-IV (ProQoL), "change" is being assessed. (time frame: Change from Baseline up to 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04372303, which also lists 8 linked publications.
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 4 May 2020.