Successes with and barriers to patient-reported outcome deployment at a comprehensive cancer center.

2018 ◽  
Vol 36 (30_suppl) ◽  
pp. 292-292
Author(s):  
Nadine Jackson McCleary ◽  
Deborah Schrag ◽  
Neil E. Martin ◽  
Sadiqa Mahmood ◽  
Elizabeth Beyer ◽  
...  
Keyword(s):  
Adverse Events ◽  
Assessment Tool ◽  
Treatment Plan ◽  
Patient Reported Outcome ◽  
Lessons Learned ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Patient Reported ◽  
Oncology Practice ◽  
Plan Modification

292 Background: Routine collection of patient reported outcomes (PROs) reduces hospitalizations and improves quality of life. In the absence of clear implementation guidelines and research guiding deployment, PROs may not have the desired impact on outcomes in routine oncology practice. We share lessons learned from PRO deployment at Dana-Farber Cancer Institute. Methods: We developed a symptom/toxicity assessment tool based on the PRO-CTCAE to capture 15 symptomatic adverse events with a 1-week recall: fatigue/ decreased appetite/insomnia/ shortness of breath/numbness and tingling/concentration, general pain/anxiety/sadness, rash, nausea/vomiting/fever, constipation, and diarrhea. Responses from eligible English-literate patients scheduled for a gastrointestinal cancer center or adult palliative care visit between January 18 to March 22, 2018 were transmitted directly from clinic tablet to the EMR. To evaluate the deployment, we sought qualitative feedback from clinic staff and three multidisciplinary working groups comprised of patients, nurses, pharmacists, operations leaders, quality/safety experts, and health services researchers to identify technical and workflow gaps in PRO Content, Implementation, and Analytics. Results: We noted a 38% response rate of the N = 4440 PROs assigned to N = 4440 scheduled visits for N = 2055 unique patients (36% were completed, 2% started but not completed); 62% were not started. Workflow enhancement requests include an updated summary view, a clinical documentation tool, a scoring algorithm to highlight severe responses, and a quality metric dashboard to evaluate the deployment. Ongoing analyses are studying the proportion of moderate-severe symptomatic adverse events reported and their association with provider action (i.e., supportive care referral, chemotherapy treatment plan modification, or unplanned ED/hospitalization in the subsequent 30 days). Conclusions: Refinement of the PRO deployment strategy is needed to guide implementation efforts and demonstrate meaningful impact in routine oncology practice.

Distribution and frequency of patient-reported symptomatic adverse events at a comprehensive cancer center.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e19117-e19117
Author(s):  
Jessica Cleveland ◽  
Michael J. Hassett ◽  
Sherry Lee ◽  
Isaac S. Chua ◽  
Laura Stewart Dominici ◽  
...  
Keyword(s):  
Adverse Events ◽  
Patient Reported Outcomes ◽  
Surgical Oncology ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Shortness Of Breath ◽  
Ambulatory Oncology ◽  
Patient Reported ◽  
Oncology Practice ◽  
Practice Methods

e19117 Background: Systematic review of electronic patient reported outcomes (ePRO) has been shown to improve quality of life and overall survival in clinical trial. We previously demonstrated feasibility of ePRO across Dana-Farber Cancer Institute (DFCI). We sought to examine the distribution and frequency of first symptomatic adverse events (SAEs) among ePRO responders in ambulatory oncology practice. Methods: The ePRO tool uses the validated NCI developed Patient Reported Outcomes – Common Terminology Criteria for Adverse Events (PRO-CTCAE) instrument to assess attributes of 15 core SAEs (fatigue, insomnia, general pain, decreased appetite, nausea, vomiting, constipation, diarrhea, shortness of breath, numbness and tingling, rash, concentration, fever, anxiety, sadness) selected by clinician stakeholders and deployed via any internet-enabled device once every 7 days. Responses are viewable in the EHR, scored 0 to 3 using an algorithm, with scores of 3 highlighted to indicate severe grade SAEs. Results: We examined the distribution and frequency of the first 5183 unique ePRO reports for unselected patients seen in the medical, radiation and surgical oncology outpatient clinics of four pilot multidisciplinary clinics (Breast, Genitourinary, Gastrointestinal and Head and Neck) between September 2018-December 2019. Twenty one percent of eligible patients responded to ePRO (5183 of 26,084). Most respondents were female (59%), Caucasian (89%), and age 50-69 years (56% compared to 16% age <50 years, 28% age ≥70; range 19-98 years). The frequency of grade 3 SAEs was pain (10%), fatigue (6%), insomnia (4%), constipation (3%), numbness and tingling/concentration/anxiety/decreased appetite (2%), diarrhea/shortness of breath/sadness (1%), and rash/fever/nausea/vomiting (none) (Table). Conclusions: We observed a consistent distribution of SAEs across cancer types, age and sex. The most frequently reported SAEs are those clinicians struggle to treat with medications - pain, fatigue, insomnia and anxiety. Research to develop effective strategies to address this constellation of SAEs should be prioritized. [Table: see text]

Performance of the patient reported CAPLET2.0 physical functioning assessment tool.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 194-194
Author(s):  
Alexandra McCartney ◽  
Julia Singer ◽  
Reenika Aggarwal ◽  
Katrina Hueniken ◽  
Raiza Commiting ◽  
...  
Keyword(s):  
Physical Function ◽  
Cancer Patients ◽  
Physical Functioning ◽  
Assessment Tool ◽  
Performance Status ◽  
Patient Reported Outcome ◽  
Cancer Center ◽  
Patient Reported ◽  
Hematological Cancers ◽  
Screening Questions

194 Background: CAPLET is a published patient reported outcome measure which assesses domains of physical function efficiently in cancer patients through a branching logic algorithm using a patient-reported outcome version of ECOG performance status and EQ5D-3L health utility score (PMID: 29982902; a total of 6 screening questions). We assessed the sensitivity and specificity of this tool after updating it with screening questions from the EQ5D-5L (CAPLET2.0) as opposed to the previously published EQ5D-3L screener (CAPLET). Methods: Eligible cancer patients across all outpatient clinics and disease sites (solid and liquid cancers) at the Princess Margaret Cancer Center completed a questionnaire on touch-screen technology containing the EQ5D-5L, patient-reported outcome (PRO)-ECOG performance scale, the gold standard WHODAS 2.0 (12 items) and HAQ-DI (20 items) physical functioning questionnaires, and a clinico-demographic survey. Results: Of 261 patients, 53% were female, 61% were Caucasian, and 71% had English as a first language. Disease sites included: 12% breast, 10% gastrointestinal, 12% genitourinary, 19% gynecological, 13% head and neck, 13% lung and 13% hematological cancers. The optimal branching logic cut-points were identified when PRO-ECOG, scored as 0-1 and individual EQ5D items scored with the best functioning category allowed specific WHODAS/HAQ-DI questions to be skipped. Against individual WHODAS-HAQ-DI items, CAPLET2.0 had sensitivities ranging from 83-100% (median 93%), and specificities of 50-82% (median 58%). Using CAPLET 2.0, 45% of patients could have skipped all but five questions measuring mental health and cognition which are always asked. Sensitivities, specificities and the proportion of questions that could have been skipped were all similar to the original CAPLET tool. Conclusions: CAPLET2.0, which uses the updated EQ5D-5L and PRO-ECOG as screening questions to assess physical function in cancer patients has comparable performance to the original CAPLET tool. CAPLET2.0 is therefore a viable alternative physical functioning screening tool for both routine and research use.

ENRICH: Validating a multidimensional patient-reported financial toxicity measure.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 153-153
Author(s):  
Grace L. Smith ◽  
Robert Joseph Volk ◽  
Lisa M Lowenstein ◽  
Susan K. Peterson ◽  
Alyssa G. Rieber ◽  
...  
Keyword(s):  
Financial Stability ◽  
Safety Net ◽  
Patient Reported Outcome ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Financial Toxicity ◽  
Socioeconomically Disadvantaged ◽  
Safety Net Hospital ◽  
Patient Reported ◽  
Future Utility

153 Background: Financial toxicity is a patient-reported outcome reflecting burdens of cancer treatment costs. There is a need to assess financial toxicity in cancer care, as its unique domains—upstream factors like direct medical costs or downstream economic impact like bankruptcy—predict worse QOL, adherence, and mortality. Socioeconomically disadvantaged patients bear disparate financial toxicity burdens. We thus developed and report performance of a new measure, the Economic StraiN and Resilience in Cancer (ENRICh), to assess all financial toxicity domains in economically diverse patients. Methods: We studied 238 patients with Stage I-IV cancer from a tertiary academic comprehensive cancer center (MDA) and county safety-net hospital serving socioeconomically disadvantaged patients (LBJ). Financial toxicity domains and corresponding subscales were developed from qualitative/cognitive (n = 104) interviews. ENRICh and Comprehensive Score for Financial Toxicity (COST) questions were administered (n = 127; MDA = 71, LBJ = 56). To demonstrate known-group validity, we compared ENRICh scores between centers; for concurrent validity, we correlated ENRICh and COST; for reliability, we calculated Cronbach's coefficient α for ENRICh subscales (range 0, none, to 10, high burden). Results: There were 4 distinct, valid financial toxicity domains/subscales: 1) Burden of cost; 2) Disruption of financial stability; 3) Depletion of financial coping; 4) Depletion of instrumental coping. Patients from the 2 centers significantly differed in subscale and overall ENRICh scores. Socioeconomically disadvantaged patients had worse mean scores (4.9 vs 2.1, 95%CI -3.6,-2.1, effect size 1.4, P < .001). ENRICh significantly correlated with COST (r = -0.82, 95%CI -0.87,-0.77, P < .001). Subscales were reliable with excellent internal consistency (Cronbach α = 0.78 to 0.94). The 4 ENRICh domains collectively had synergistic impact on overall financial toxicity burden. Conclusions: ENRICh is valid, reliable, and identifies and 4 novel domains of financial toxicity. Future utility of this tool is to guide assessment/interventions targeting financial toxicity domains affecting diverse cancer patients, to mitigate disparities.

A digital therapeutic for proactive monitoring of patients on immune checkpoint inhibitor therapy for early detection of immune-related adverse events.

2020 ◽  
Vol 38 (5_suppl) ◽  
pp. 101-101
Author(s):  
Shyamali Mallick Singhal ◽  
Shane Dormady ◽  
Jiali Li ◽  
Shiva Singhal ◽  
Lynda Chin
Keyword(s):  
Early Detection ◽  
Adverse Events ◽  
Clinical Care ◽  
Patient Reported Outcome ◽  
Feasibility Trial ◽  
Cancer Center ◽  
Evidence Based ◽  
Close Monitoring ◽  
Patient Reported ◽  
Proactive Monitoring

101 Background: Immune-related adverse events (irAEs) occur frequently in patients receiving immuno-oncology therapy. irAEs are heterogeneous and unpredictable. Experience at academic cancer centers has shown that (1) education of patients and families must be continuous; (2) experience of the care team can improve outcomes; and (3) close monitoring of patients in between visits translate into early detection and timely intervention. Most oncologists in lower volume community practices have not gained the experience nor have the resource for continuous education frequent proactive monitoring. Methods: In addition to self-monitoring by patients on chemotherapy to improve outcome (Basch ref), we hypothesized that adoption of evidence-based management is critical as well. Thus, we have developed ApricityRx, a digital therapeutic (DTx) for end-to-end irAE management, which not only engages patients in frequent self-nonitoring but also activates the oncology team for timely intervention. In brief, ApricityRx (i) enables intelligent monitoring by educating and guiding patients to track specific expert-prioritized symptoms in between clinic visits; (ii) facilitates early recognition by prompting triage at the right time and (iii) recommends evidence-based management based on consensus guidelines. Results: In a community cancer center, 16 patients have been enrolled (44% consent rate) in an IRB approved feasibility trial to evaluate the usability of ApricityRx as a tool for frequent monitoring and timely triage. Over 435 unique longitudinal records containing over 34K data points, including patient-reported outcome (PRO) and clinical care data (EMR), were generated. Interim analyses have shown that primary and secondary endpoints were met. Detailed results will be presented. Conclusions: ApricityRx has shown usability in a low-volume community-based oncology practice to facilitate proactive monitoring and tinely triage by the oncology team. Further, ApricityRx has enabled not only generation of high-resolution patient-reported outcome (PRO) data, but also aggregation of PRO and real-world EHRs data for downstream analyses.

Inclusion of spiritual pain in patient reported outcome assessments as part of an integrative medicine physician consultation.

2017 ◽  
Vol 35 (31_suppl) ◽  
pp. 190-190
Author(s):  
Gabriel Lopez ◽  
Wenli Liu ◽  
Minxing Chen ◽  
Yisheng Li ◽  
Alejandro Chaoul ◽  
...  
Keyword(s):  
Integrative Medicine ◽  
Psychological Health ◽  
Psychological Needs ◽  
Physical Symptoms ◽  
Patient Reported Outcome ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Medicine Physician ◽  
Patient Reported ◽  
Edmonton Symptom Assessment Scale

190 Background: Complementary and integrative health services are increasingly available to patients at cancer centers to help address physical and psychological needs. We review inclusion of spiritual pain (SP) as part of patient reported outcome (PRO) assessments in patients presenting for an outpatient integrative medicine consultation at a comprehensive cancer center. Methods: PRO data were collected as part of outpatient physician consultations at an integrative medicine clinic; we reviewed data between January 2013 and April 2017. Patients completed the Edmonton Symptom Assessment Scale (ESAS-FS, 12 symptoms, scale 0-10, 10 worst possible) immediately prior to the clinical encounter. ESAS distress subscales analyzed included psychological, physical, and global. Statistical analyses included summary statistics, two sample t-tests, correlations, and logistic regression. Results: We analyzed data from 4348 unique participants. Demographics included 65% women, average age 55.5, 78% Caucasian, 72% married or with significant other, majority Christian non-Catholic (49%) followed by non-specified (23%), and Catholic (20%). Overall, 41% of patients reported SP at baseline. Patients reporting a SP score of ≥ 1 (n = 1549) reported significantly higher levels of global, physical, and psychological distress than patients with SP scores of 0 (n = 2275) (all p’s < 0.001). Older patients and men were less likely to report SP. SP clustered with psychological symptoms of depression and anxiety (reliability coefficient 0.76). Conclusions: A significant number of cancer patients presenting for integrative medicine consultations reported having SP, with SP clustering with psychological versus physical symptoms. More research is needed to better understand how routine screening for SP contributes to assessments of overall psychological health.

Frequency and distribution of gastrointestinal oncology patient-reported symptomatic adverse events (SAEs) at a comprehensive cancer center.

2021 ◽  
Vol 39 (3_suppl) ◽  
pp. 463-463
Author(s):  
Nadine Jackson McCleary ◽  
Ellana Haakenstad ◽  
Jessica Cleveland ◽  
Sunyi Zhang ◽  
Michael J. Hassett ◽  
...  
Keyword(s):  
Adverse Events ◽  
Gastrointestinal Cancer ◽  
Symptom Management ◽  
Patient Reported Outcomes ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Shortness Of Breath ◽  
Management Interventions ◽  
Patient Reported ◽  
Race Ethnicity

463 Background: In clinical trials, the systematic collection of patient (pt) reported outcomes has been shown to improve quality of life & overall survival. To develop predictive care models for symptom management, we explored the frequency & distribution of SAEs reported by pts who reported electronic patient reported outcomes (ePRO) prior to outpatient visits to the Gastrointestinal Cancer Center (GCC) at Dana Farber Cancer Institute (DFCI). Methods: ePRO is a modified NCI Patient Reported Outcomes – Common Terminology Criteria for Adverse Events instrument distributed weekly to GCC pts with a medical/surgical/radiation oncology encounter. Responses are available to the care team in the electronic health record. ePRO consists of presence/frequency/severity/interference of 15 core SAEs (fatigue, insomnia, general pain, decreased appetite, nausea, vomiting, constipation, diarrhea, shortness of breath, numbness and tingling, rash, concentration, fever, anxiety, sadness). Responses are scored 0 to 3 (with 2 and 3 indicating moderate and severe SAEs, respectively). We examined the frequency & distribution of grade 2 and 3 SAEs in ePRO responders by age, gender, race/ethnicity. All pts had gastrointestinal cancer and an outpatient visit for treatment, symptom management, follow-up care. Results: From 9/1/2018 to 8/31/2020, 1912 unique pts responded (response rate 23%). Most respondents were age 50-69 years (58% compared to 15% age <50, 27% age ≥70; range 18-95), male (53%), white (75%). Grade 3 SAE frequencies were pain (12%), fatigue (11%), anxiety/constipation/insomnia/decreased appetite (5%), sadness/numbness and tingling/diarrhea (3%), concentration/shortness of breath (2%), nausea/rash (1%), fever/vomiting (0%). Across pts, fatigue, general pain, insomnia, anxiety were the most common grade 2 and 3 SAEs. Shortness of breath, vomiting, rash, fever were least common (Table). Conclusions: In GCC pts responding to ePRO, the most frequent SAEs were pain, fatigue, insomnia, anxiety. Shortness of breath, nausea, vomiting, diarrhea were less often severe. Pts <50 were more likely to report severe anxiety but there were no other major differences based on age, sex, race/ethnicity. Ongoing efforts will increase pt/provider engagement and develop predictive models & symptom management interventions from ePRO responses. [Table: see text]

Optimizing electronic capture of patient-reported outcome measures in oncology clinical trials: lessons learned from a qualitative study

2020 ◽  
Vol 9 (17) ◽  
pp. 1195-1204
Author(s):  
Florence D Mowlem ◽  
Brad Sanderson ◽  
Jill V Platko ◽  
Bill Byrom
Keyword(s):  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Lessons Learned ◽  
Structured Interviews ◽  
Patient Reported ◽  
Oncology Clinical Trials ◽  
Anticancer Treatment ◽  
Fit For Purpose ◽  
The Impact ◽  
Electronic Implementation

Aim: To understand the impact of anticancer treatment on oncology patients’ ability to use electronic solutions for completing patient-reported outcomes (ePRO). Materials & methods: Semi-structured interviews were conducted with seven individuals who had experienced a cancer diagnosis and treatment. Results: Participants reported that the following would impact the ability to interact with an ePRO solution: peripheral neuropathy of the hands (4/7), fatigue and/or concentration and memory issues (6/7), where they are in a treatment cycle (5/7). Approaches to improve usability included: larger, well-spaced buttons to deal with finger numbness, the ability to pause a survey and complete at a later point and presenting the recall period with every question to reduce reliance on memory. Conclusion: Symptoms associated with cancers and anticancer treatments can impact the use of technologies. The recommendations for optimizing the electronic implementation of patient-reported outcome instruments in this population provides the potential to improve data quality in oncology trials and places patient needs at the forefront to ensure ‘fit-for-purpose’ solutions.

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.

scholarly journals Changes in fatigue, barriers, and predictors towards physical activity in advanced cancer patients over a period of 12 months—a comparative study

2021 ◽  
Author(s):  
J. Frikkel ◽  
M. Beckmann ◽  
N. De Lazzari ◽  
M. Götte ◽  
S. Kasper ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Physical Functioning ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Advanced Cancer Patients ◽  
Psychological Conditions ◽  
Patient Reported

Abstract Purpose Physical activity (PA) is recommended to improve advanced cancer patients’ (ACP) physical functioning, fatigue, and quality of life. Yet, little is known about ACPs’ attitude towards PA and its influence on fatigue and depressiveness over a longer period. This prospective, non-interventional cohort study examined ACPs’ fatigue, depression, motivation, and barriers towards PA before and after 12 months of treatment among ACP Methods Outpatients with incurable cancer receiving treatment at a German Comprehensive Cancer Center reporting moderate/severe weakness/tiredness during self-assessment via MIDOS II were enrolled. Fatigue (FACT-F), depression (PHQ-8), cancer-related parameters, self-assessed PA behavior, motivation for and barriers against PA were evaluated (T0). Follow-up data was acquired after 12 months (T1) using the same questionnaire. Results At follow-up, fatigue (p=0.017) and depressiveness (p=0.015) had increased in clinical relevant extent. Physically active ACP did not show significant progress of FACT-F (p=0.836) or PHQ-8 (p=0.799). Patient-reported barriers towards PA remained stable. Logistic regression analyses identified motivation as a positive predictor for PA at both time points (T0, β=2.152, p=0.017; T1, β =2.264, p=0.009). Clinically relevant depression was a negative predictor for PA at T0 and T1 (T0, β=−3.187, p=0.044; T1, β=−3.521, p=0.041). Conclusion Our findings emphasize the importance of psychological conditions in physical activity behavior of ACP. Since psychological conditions seem to worsen over time, early integration of treatment is necessary. By combining therapy approaches of cognitive behavioral therapy and exercise in interdisciplinary care programs, the two treatment options might reinforce each other and sustainably improve ACPs’ fatigue, physical functioning, and QoL. Trial registration German Register of Clinical Trials, DRKS00012514, registration date: 30.05.2017

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