Feasibility, Acceptability, and Preliminary Effectiveness of a Compassion-Centered Team Intervention to Improve Clinical Research Coordinator Resilience and Well-Being

2021 ◽  
pp. OP.21.00120
Author(s):  
Jennifer S. Mascaro ◽  
Patricia K. Palmer ◽  
Marcia J. Ash ◽  
Caroline Peacock ◽  
Anuja Sharma ◽  
...  
Keyword(s):  
Clinical Research ◽  
Well Being ◽  
Self Report ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Clinical Research Coordinator ◽  
Individual Resilience ◽  
Clinical Research Coordinators ◽  
Research Coordinator ◽  
The Impact

PURPOSE: Oncology clinical research coordinators (CRCs) and team-based coordinator care are critical for the success of clinical trials. However, CRCs typically report elevated anxiety and burnout and many oncology centers have high levels of coordinator attrition. To address the need for a team-based intervention to reduce burnout and promote resilience and cohesion among CRCs, we developed a compassion-centered, team-based intervention, Compassion-Centered Spiritual Health Team Intervention (CCSH-TI). METHODS: Participants were CRCs working in disease-specific teams within a comprehensive cancer center. CRCs were randomly assigned by team to either participate in four 60-minute sessions of CCSH-TI or receive the intervention after the study. To evaluate whether CCSH-TI is feasible and acceptable, we used a mixed-method approach including self-report questionnaires and a focus group. To evaluate the impact of CCSH-TI, we assessed self-reported resilience, well-being, burnout, and team civility before and immediately after the intervention period (ClinicalTrials.gov identifier: NCT04060901 ). RESULTS: Attendance varied by team, but all teams had rates more than 60%. Coordinators rated high levels of credibility of CCSH-TI to improve burnout, and the majority reported that they received benefits, particularly in resilience and stress management, indicating acceptability. Coordinators randomly assigned to CCSH-TI reported an increase in resilience compared with coordinators randomly assigned to the wait-list group (F(41) = 4.53, P = .039). CONCLUSION: Data from this pilot study indicate that CCSH-TI may be a feasible, credible, acceptable, and effective intervention to augment individual resilience among CRCs. However, the quantitative and qualitative data suggest that more comprehensive and systematic programming is necessary to truly mitigate burnout.

Improving the efficiency and effectiveness of clinical research regulatory review processes: Lessons from the Six Sigma Body of Knowledge

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e17554-e17554
Author(s):  
D. C. Stahl ◽  
C. J. Song ◽  
R. A. Figlin
Keyword(s):  
Adverse Events ◽  
Clinical Research ◽  
Process Improvement ◽  
Six Sigma ◽  
Review Process ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Regulatory Review ◽  
Efficiency And Effectiveness ◽  
The Impact

e17554 Background: The duration and complexity of regulatory review processes are increasingly associated with the slow pace and high cost of clinical trials. To evaluate and minimize the impact of these factors, City of Hope (COH), a NCI-designated Comprehensive Cancer Center, developed a strategic initiative to improve the efficiency and effectiveness of its clinical research review processes. The ongoing initiative is supported by Six Sigma-based techniques for problem identification and process optimization that have been successfully applied in other industries. Methods: The Six Sigma process improvement methodology known as DMAIC (Define, Measure, Analyze, Improve, and Control) was applied to five different clinical trial submission types (new study submissions, amendments, continuations, internal adverse events, external adverse events) reviewed by the COH Institutional Review Board (IRB), Cancer Protocol Review and Monitoring Committee (CPRMC), and Data and Safety Monitoring Board (DSMB). A consistent set of metrics and expectations were created for each review process to evaluate pre-review queue times, review process durations, submissions returned for corrections, and submissions returned with conditional approvals. Results: Over 7,900 submissions received during a 15 month period were evaluated quarterly to identify opportunities for improvement and the effects of previously implemented solutions. Multiple root causes for submission defects and delays were identified, including: (1) staffing and training deficiencies, (2) suboptimal workload distribution, (3) unclear policies and processes, (4) submission standardization opportunities, and (5) workflow automation and other information technology opportunities. Ongoing remediation efforts have yielded substantial improvements. Conclusions: Although Six Sigma process improvement techniques were originally developed for manufacturing applications, they can be applied in a clinical research setting to improve regulatory review processes. The methodology was most effectively introduced incrementally via application to specific problems rather than a traditional top-down implementation. Support provided by NCI P30 CA33572. No significant financial relationships to disclose.

scholarly journals How do clinical research coordinators learn Good Clinical Practice? A mixed-methods study of factors that predict uptake of knowledge

2020 ◽  
Vol 17 (2) ◽  
pp. 166-175
Author(s):  
Jessica T Mozersky ◽  
Alison L Antes ◽  
Kari Baldwin ◽  
Michelle Jenkerson ◽  
James M DuBois
Keyword(s):  
Clinical Practice ◽  
Clinical Research ◽  
Qualitative Interviews ◽  
Good Clinical Practice ◽  
National Institutes Of Health ◽  
Face To Face ◽  
Clinical Research Coordinator ◽  
Clinical Research Coordinators ◽  
Research Coordinator ◽  
Practice Knowledge

Background: Good Clinical Practice is an international standard for the design and conduct of clinical trials to ensure ethical and scientific integrity. Recent National Institutes of Health policy mandates Good Clinical Practice training for all investigators and staff involved in National Institutes of Health–funded clinical trials, yet approaches to Good Clinical Practice training vary widely. There are limited data on Good Clinical Practice knowledge among the clinical trial workforce and no evidence regarding effective methods to learn Good Clinical Practice. Methods: We used an exploratory sequential mixed-methods design. We conducted 18 exploratory qualitative interviews with clinical research coordinators to help inform the development of the quantitative survey. We then administered a validated 32-item, multiple-choice test of Good Clinical Practice knowledge with a survey of work and training experiences to 625 clinical research coordinators at three academic medical centers in the United States. Variables that were significantly associated with Good Clinical Practice knowledge were entered into a multiple regression analysis to identify unique predictors of Good Clinical Practice knowledge. We controlled for verbal–numerical reasoning and learning orientation. Results: During qualitative interviews, clinical research coordinators reported that formal Good Clinical Practice training had value but they simultaneously emphasized the importance of experience, day-to-day practice, and observing colleagues and mentors as essential to supplement formal training. In our quantitative survey, five variables predicted a total of 22% of variance in Good Clinical Practice knowledge scores: years of experience as a clinical research coordinator, working on diverse types of trials, supporting industry-funded trials, being certified in clinical research coordination, and aggregated hours of online and face-to-face training (in that order). Conclusion: The duration and richness of experience as a clinical research coordinator were the strongest predictors of Good Clinical Practice knowledge, a finding consistent with our exploratory qualitative interview results. Our findings suggest that formal online and face-to-face training has a minimal influence on Good Clinical Practice knowledge. The type of training—whether online or face to face—does not make a significant difference in Good Clinical Practice knowledge scores. Much of the variance in Good Clinical Practice knowledge remains unexplained, calling for further research in this area.

scholarly journals Assessing clinical research coordinator knowledge of good clinical practice: An evaluation of the state of the art and a test validation study

2020 ◽  
Vol 4 (2) ◽  
pp. 141-145 ◽  
Author(s):  
James M. DuBois ◽  
Jessica T. Mozersky ◽  
Alison L. Antes ◽  
Kari Baldwin ◽  
Michelle Jenkerson
Keyword(s):  
Clinical Practice ◽  
Clinical Research ◽  
Good Clinical Practice ◽  
Knowledge Test ◽  
Good Reliability ◽  
Clinical Research Coordinator ◽  
Clinical Research Coordinators ◽  
Research Coordinator ◽  
Effectiveness Of Training ◽  
Development And Validation

AbstractThis paper describes the development and validation of a new 32-item test of knowledge of good clinical practice (GCP) administered to 625 clinical research coordinators. GCP training is mandated by study sponsors including the US National Institutes of Health. The effectiveness of training is rarely assessed, and the lack of validated tests is an obstacle to assessment. The GCP knowledge test was developed following evaluation of two existing widely used GCP tests to ensure it accurately reflects the content of current training. The final GCP knowledge test demonstrated good reliability (α = 0.69). It is a valid and reliable instrument for measuring knowledge of GCP. The test will be useful in assessing the effectiveness of GCP training programs as well as individuals’ mastery of GCP content.

scholarly journals Incivility Is Associated with Burnout and Reduced Compassion Satisfaction: A Mixed-Method Study to Identify Causes of Burnout among Oncology Clinical Research Coordinators

2021 ◽  
Vol 18 (22) ◽  
pp. 11855
Author(s):  
Jennifer S. Mascaro ◽  
Patricia K. Palmer ◽  
Marcia J. Ash ◽  
Caroline Peacock ◽  
Cam Escoffery ◽  
...  
Keyword(s):  
Focus Group ◽  
Clinical Research ◽  
Mixed Method ◽  
Compassion Satisfaction ◽  
Well Being ◽  
Self Report ◽  
Clinical Research Coordinators ◽  
Increased Risk ◽  
Nuanced Understanding ◽  
The Individual

While oncology clinical research coordinators (CRCs) experience a combination of factors that are thought to put them at increased risk for burnout, very little research has been conducted to understand the risk factors associated with burnout among CRCs. We used a mixed-method approach, including self-report questionnaires to assess burnout and compassion satisfaction, as well as individual and interpersonal variables hypothesized to impact CRC well-being. We also conducted a focus group to gain a more nuanced understanding of coordinators’ experiences around burnout, teamwork, resilience, and incivility. Coordinators reported relatively moderate levels of burnout and compassion satisfaction. Resilience, sleep dysfunction, stress, and incivility experienced from patients/family were significant predictors of burnout. Resilience and incivility from patients/family were significant predictors of compassion satisfaction. Themes that emerged from the focus group included that burnout is triggered by feeling overwhelmed from the workload, which is buffered by what was described as a supportive work culture based in teamwork. This study identified variables at the individual and interpersonal level that are associated with burnout and compassion satisfaction among oncology CRCs. Addressing these variables is of critical importance given that oncology CRCs and team-based coordinator care are vital to the success of clinical trials.

Self report assessment and support for cancer symptoms: Impact on hospital admissions and emergency department visits.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20552-e20552 ◽  
Author(s):  
Donna Lynn Berry ◽  
Fangxin Hong ◽  
Traci Blonquist ◽  
Barbara Halpenny ◽  
Mary Lou Siefert ◽  
...  
Keyword(s):  
Emergency Department ◽  
Hospital Admissions ◽  
Intervention Group ◽  
Emergency Department Visits ◽  
Self Report ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Unequal Variance ◽  
Cancer Symptoms ◽  
The Impact

e20552 Background: Attending to symptoms and side effects promotes safe and effective delivery of cancer therapies. Educated and supported patients (Pts) may be able to self-manage symptoms (Sx) and know when to contact the clinician, avoiding emergency department visits (EDV) or hospital admissions (HA). The web-based Electronic Self Report Assessment for Cancer (ESRA-C) is an easy-to-use, automated program for assessing and teaching about symptom and quality of life issues (SQI) and has been shown to improve communication and reduce symptom distress over the course of active therapy. The purpose of this secondary analysis was to explore the impact of the ESRA-C intervention on rates of EDV and HA. Methods: AdultPts with all cancer types and stages treated in medical and radiation oncology at a comprehensive cancer center used ESRA-C to self-report SQI during new anti-cancer therapy, with summary reports delivered to clinicians. Patients were randomized to assessment-only ESRA-C (control) or the ESRA-C intervention adding self-monitoring and education and coaching between clinic visits. We analyzed group differences on EDV and HA using descriptive statistics and a two group unequal variance t-test. Results: Among 663 Pts, 34 out of 327 control Pts made 47 EDV vs 30 out of 336 intervention Pts made 42 visits. Likewise, 36 control Pts had 59 HA vs 36 intervention Pts who had 41 HA during the study duration. The majority of EDV (87%) and HA (88%) were Sx-related. The frequency of Sx-related events (EDV or HA) was higher in the control (n=94) vs the intervention group (n=71). The mean number of unplanned events were 0.29 and 0.21 per patient in the control and intervention groups, respectively (p=0.24). Conclusions: Although the trial sample size was not planned to test differences in EDV or HA, the ESRA-C intervention, compared with assessment alone, may have reduced symptom-related EDV and HA in a large sample of patients during active cancer treatment. If we are able to reduce Sx-related unplanned visits and admissions from more than 1 of 4 patients to 1 of 5 patients with an automated, patient-centered system, we can anticipate substantial cost savings when scaled to the volume of most comprehensive cancer centers. Clinical trial information: NCT00852852.

Oncology massage impact on patient with cancer and caregiver self-reported symptoms as part of an integrative oncology program at a comprehensive cancer center.

2016 ◽  
Vol 34 (26_suppl) ◽  
pp. 79-79
Author(s):  
Gabriel Lopez ◽  
Kathrin Milbury ◽  
Amy Spelman ◽  
Qi Wei ◽  
Pamela A Sumler ◽  
...  
Keyword(s):  
Outpatient Clinic ◽  
Symptomatic Relief ◽  
Psychological Symptom ◽  
Well Being ◽  
Physical Symptoms ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Edmonton Symptom Assessment Scale ◽  
Oncology Massage ◽  
The Impact

79 Background: Massage as a manual therapy has shown benefit for symptomatic relief in patients with cancer and their caregivers. We explored the impact of a single massage session on self-reported symptoms in an outpatient clinic at a comprehensive cancer center. Methods: Patients and caregivers received oncology massage treatments (30 or 60-min duration) at our Integrative Medicine Center outpatient clinic from Sep 2012-Jan 2015. Participants completed a modified Edmonton Symptom Assessment Scale (ESAS; 0-10 scale, 10 most severe) pre- and post-massage. ESAS individual items and subscales scores of Physical Distress (PHS), Psychological Distress (PSS), and Global Distress (GSD) were analyzed. We used paired t-tests with a Bonferroni correction (i.e., p < .001) to examine pre/post massage self-reported symptoms. Results: Initial massage visits for 164 patients and 39 caregivers were analyzed. Highest symptoms burden (means) at baseline for patients were Sleep 3.93, Fatigue 3.70, and poor sense of Well-Being 3.62; for caregivers Distress 4.14, Sadness 3.43, and Sleep 3.21. Although patients reported significantly more physical symptoms (F = 27.56, P < .0001) compared to caregivers at baseline, groups did not differ in regard to psychological symptom burden (P = .75). Massage therapy was associated with significant improvements in PHS, PSS, and GSD for both patients and caregivers at P < .0001. Including participants with symptom report ≥ 1, massage resulted in a clinically significant improvement (reduction ≥ 1) in pain, fatigue, sleep, distress, dry mouth, sadness, numbness, anxiety, wellbeing for patients; pain, fatigue, distress, sadness, numbness, anxiety, wellbeing for caregivers. Regarding massage duration, there were no significant effects for 30 vs 60-min duration on pre/post ESAS difference scores. Conclusions: A single 30- or 60-minute massage session resulted in acute relief of self-reported symptoms in patients and caregivers. Further study is warranted regarding optimal massage dose and frequency.

scholarly journals Enhancing Patient-Provider Communication With the Electronic Self-Report Assessment for Cancer: A Randomized Trial

2011 ◽  
Vol 29 (8) ◽  
pp. 1029-1035 ◽  
Author(s):  
Donna L. Berry ◽  
Brent A. Blumenstein ◽  
Barbara Halpenny ◽  
Seth Wolpin ◽  
Jesse R. Fann ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Clinic Visit ◽  
Self Report ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Control Group ◽  
Cancer Symptoms ◽  
Patient Reported ◽  
Life Issues ◽  
Clinic Visits

Purpose Although patient-reported cancer symptoms and quality-of-life issues (SQLIs) have been promoted as essential to a comprehensive assessment, efficient and efficacious methods have not been widely tested in clinical settings. The purpose of this trial was to determine the effect of the Electronic Self-Report Assessment–Cancer (ESRA-C) on the likelihood of SQLIs discussed between clinicians and patients with cancer in ambulatory clinic visits. Secondary objectives included comparison of visit duration between groups and usefulness of the ESRA-C as reported by clinicians. Patients and Methods This randomized controlled trial was conducted in 660 patients with various cancer diagnoses and stages at two institutions of a comprehensive cancer center. Patient-reported SQLIs were automatically displayed on a graphical summary and provided to the clinical team before an on-treatment visit (n = 327); in the control group, no summary was provided (n = 333). SQLIs were scored for level of severity or distress. One on-treatment clinic visit was audio recorded for each participant and then scored for discussion of each SQLI. We hypothesized that problematic SQLIs would be discussed more often when the intervention was delivered to the clinicians. Results The likelihood of SQLIs being discussed differed by randomized group and depended on whether an SQLI was first reported as problematic (P = .032). Clinic visits were similar with regard to duration between groups, and clinicians reported the summary as useful. Conclusion The ESRA-C is the first electronic self-report application to increase discussion of SQLIs in a US randomized clinical trial.

Mindfulness-based stress reduction for people with chronic diseases

2010 ◽  
Vol 16 (3) ◽  
pp. 200 ◽  
Author(s):  
Monika Merkes
Keyword(s):  
Quality Of Life ◽  
Chronic Diseases ◽  
Stress Reduction ◽  
Well Being ◽  
Multiple Chemical Sensitivity ◽  
Self Report ◽  
Original Research ◽  
Mindfulness Based Stress Reduction ◽  
The Impact

Mindfulness-based stress reduction (MBSR) is a structured group program that uses mindfulness meditation to improve well-being and alleviate suffering. This article reviews the impact of MBSR for people with chronic diseases. The review includes original research that was published in English and peer-reviewed and reported outcomes for adults with chronic diseases who had participated in an MBSR program. Fifteen studies were identified. Outcomes related to mental and physical health, well-being, and quality of life. The studies included different research designs, and used self-report and physiological outcome measures. Participants’ clinical diagnoses included fibromyalgia, chronic pain, rheumatoid arthritis, type 2 diabetes, chronic fatigue syndrome, multiple chemical sensitivity, and cardiovascular diagnoses. All 15 studies found that participation in an MBSR program resulted in improvements. No negative change was reported between baseline and follow up. Outcomes in regard to specific variables were difficult to compare and equivocal. Overall, positive change predominated. Chronic diseases are associated with a range of unwelcome psychological and physical consequences. Participation in an MBSR program is likely to result in coping better with symptoms, improved overall well-being and quality of life, and enhanced health outcomes. As an adjunct to standard care, MBSR has potential for much wider application in Australian primary care settings.

scholarly journals Fears, beliefs, and quality of life of patients with cancer vs the general population during the coronavirus disease 2019 (COVID-19) pandemic in Lombardy

2021 ◽  
pp. 030089162110228
Author(s):  
Carla Ida Ripamonti ◽  
Giacomo Massa ◽  
Daniela Insolvibile ◽  
Mauro Guglielmo ◽  
Guido Miccinesi ◽  
...  
Keyword(s):  
Quality Of Life ◽  
General Population ◽  
Perceived Risk ◽  
Well Being ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Psychological Consequences ◽  
Patients With Cancer ◽  
Fear Of Cancer

Aim: To understand how patients with cancer reacted to the coronavirus disease 2019 (COVID-19) pandemic and whether their quality of life (QoL) was affected. Methods: In June 2020, 111 patients with cancer treated in the supportive care unit of a Comprehensive Cancer Center in Milan and 201 healthy controls from the general population were enrolled and assessed both quantitatively and qualitatively for fears and COVID-19–related beliefs as well as for QoL. Results: Fear of COVID-19 was significantly lower among patients (41% vs 57.6%; p = 0.007), as was fear of cancer (61.5% vs 85.6%; p < 0.001) and other diseases. The perceived risk of getting COVID-19 was lower among patients (25.2% vs 52.7%; p < 0.001), as was the belief of having been exposed to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) (18.1% vs 40.8%; p < 0.001). The physical component of QoL was better among the population (54.5 vs 43.8; p < 0.001); the reverse was true for patients’ psychological well-being (44.6 vs 39.6; p < 0.001). The qualitative data supported such results, showing a reduced psychological effect on the patients with cancer compared to the controls. Various reasons explain this result, including the awareness of being treated for cancer and nevertheless protected against getting infected in a cancer center of public health reorganized to continue treating patients by protecting them and personnel from the risk of infection. Conclusions: The experience of a cancer diagnosis, together with proper hospital reorganization, may act as protective factors from fears and psychological consequences of the COVID-19 outbreak.

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