A new symptom measure in gastrointestinal stomal tumors.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17508-e17508 ◽  
Author(s):  
Loretta A. Williams ◽  
Dejka M. Araujo ◽  
Tito R. Mendoza ◽  
Mary L Sailors ◽  
Nazim N Ali ◽  
...  
Keyword(s):  
Symptom Severity ◽  
Clinical Care ◽  
Reliability And Validity ◽  
Symptom Burden ◽  
Patient Reported Outcome ◽  
Response To Therapy ◽  
Major Barrier ◽  
Specific Symptom ◽  
Disease Information ◽  
Patient Reported

e17508 Background: Symptom burden is the combined impact of disease- and treatment-related symptoms on daily functioning. A major barrier to effective symptom management in gastrointestinal stromal tumors (GIST) is inadequate assessment. Our aim was to develop a short, valid, reliable patient-reported outcome measure of GIST symptoms for research and practice. Methods: After giving IRB-approved informed consent, 110 patients with GIST completed the 13 symptom severity and 6 interference items of the core MD Anderson Symptom Inventory (MDASI) plus 9 GIST-specific symptom items generated from patient and expert input. Items were measured on a 0-10 scale (0 = none, 10 = worst imaginable). 65 patients completed the same items 1 day later. Patients also answered a single overall quality-of-life (QOL) question. Demographic and disease information was collected on all patients. Psychometric procedures determined reliability and validity of the MDASI-GIST. Results: Mean subject age was 59.2 years (standard deviation [sd] = 11.9). 54% of the subjects were female, 85% were white, 47% were employed, 55% were on imatinib, and 30% had no evidence of disease. Mean overall QOL rating was 8.1 (best = 10, sd = 2.0). Symptoms reported as most severe were fatigue (mean [M] = 2.65, sd = 2.66), drowsiness (M = 2.36, sd = 2.55), disturbed sleep (M = 2.18, sd = 2.55), and muscle soreness/cramping (M = 2.18, sd = 2.67). Two items (abdominal swelling and malaise) were eliminated for redundancy. Internal consistency (Cronbach α) and test-retest reliability of the 20 symptom items were 0.94 and 0.93, respectively, and of the 6 interference items were 0.94 and 0.87, respectively. The mean severity of the 20 symptom items was significantly correlated with QOL rating (correlation = -0.7, P < 0.001). Mean GIST-specific symptom severity and symptom interference discriminated between patients who were employed and patients who were disabled (P = 0.05 and 0.03, respectively). Conclusions: We have validated an analytic tool, the MDASI-GIST, to quantify GIST symptom burden, assess side effects in treatment trials, and monitor symptoms in clinical care. Additional research on the longitudinal symptom burden of GIST, including differences based on type of therapy and response to therapy, is ongoing.

Implementation of a novel patient-reported outcomes measure for patients with cancer and COVID-19 infection.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 153-153
Author(s):  
Ishwaria Mohan Subbiah ◽  
Tito R. Mendoza ◽  
Xuetao Lu ◽  
Yanhong Zhou ◽  
J. Jack Lee ◽  
...  
Keyword(s):  
Longitudinal Study ◽  
Sleep Disturbance ◽  
Symptom Severity ◽  
Symptom Burden ◽  
Patient Reported Outcome ◽  
Validity And Reliability ◽  
Specific Patient ◽  
Patient Reported ◽  
Health Rating

153 Background: The long-term symptoms from COVID-19 (C19) infection in pts with cancer is not fully known. To monitor the evolution of this symptom burden over time, we designed and implemented a C19-specific patient-reported outcome (PRO) measure that integrated with a known measure of cancer symptom burden. Methods: Within the institutional initiative on C19 and cancer named Data-Driven Determinants for C19 Oncology Discovery Effort (D3CODE), pts with cancer & PCR-pos C19 are invited to participate in this longitudinal study. Pts complete the EQ-5D-5L, the 13 symptom severity & 6 interference items of the core MD Anderson Symptom Inventory (MDASI)+14 COVID-specific items, all scored on a 0-10 scale, 0 = none, 10 = worst imaginable. Pts complete the survey daily x 14 days from positive test date, then weekly x 3months, then monthly x 2yrs. Demographic and disease information was collected. Psychometric procedures determined validity and reliability of the MDASI-COVID. Results: Between 5/15/20 – 02/14/21, 2154 pts w PCR-confirmed C19 were invited to participate in the longitudinal study. 1282 (60%) pts provided consent and began the longitudinal completion of PRO surveys. Pts were 54.5% Female and 45.5% Male, median age 59 years (range 15 – 92). 1021 (80%) are White/Caucasian, 206 (16%) Hispanic, 113 (9%) African American, and 39 (3%) Asian. The validation analysis of MDASI-COVID instrument included the 1st 600 pts where the mean overall health rating on EQ-5D-5L was 78.3 (SD 19.6), best being 100. Highest mean (M) severity symptoms on the MDASI-COVID were fatigue (M 3.45, SD 2.17), drowsiness (M 2.50, SD 2.89), sleep disturbance (M 2.44, SD 2.99), malaise (M 2.37, SD 3.05), and distress (M 2.27, SD 2.90). Most severe (≥ 7) symptoms) reported were fatigue (21.3% of pts), change in taste (14.8%), change in smell (14.4%), malaise (14.3%), sleep disturbance (14.3%), and drowsiness (14%). showed internal consistency (Cronbach α) of the 27 symptom items was 0.957, of the 6 interference items was 0.937. Mean severity of the 27 symptom items was significantly correlated with overall EQ-5D-5L health rating (correlation = -0.45, P < 0.0005), demonstrating concurrent validity. Mean symptom severity and interference showed known-group validity between pts who required hospitalization (symptom M 2.32, SD 2.09; interference M 3.29, SD 3.02) and those who did not (symptom M 1.69, SD 1.85; interference M 2.20, SD 2.64) (symptom P 0.007; interference P 0.004). Conclusions: We successfully deployed a PRO-based long-term symptom monitoring platform for pts with C19 and cancer. The validation analysis of this novel C19 specific PRO, the MDASI-COVID, aids in the quantification of the global symptom burden in pts with both cancer and COVID-19 infection. Deployment of this measure in the ongoing longitudinal observational cohort allows for in-depth understanding of the long-term symptoms related to C19 and cancer.

P12.03 A Delphi survey to inform core ‘red flag’ symptoms for an electronic patient reported outcome system in glioblastoma follow up

2021 ◽  
Vol 23 (Supplement_2) ◽  
pp. ii31-ii31
Author(s):  
A Luis ◽  
F Boele ◽  
T Booth
Keyword(s):  
Reporting System ◽  
Clinical Care ◽  
Surrogate Marker ◽  
Symptom Burden ◽  
Patient Reported Outcome ◽  
Symptom Reporting ◽  
Patient Acceptability ◽  
Patient Reported ◽  
Red Flag

Abstract BACKGROUND Glioblastoma is a common and aggressive primary malignant brain tumour in adults associated with a poor prognosis and considerable symptom burden. Clinical review and serial neuroimaging remain the primary monitoring tools to assess for disease status. However, the evidence base for the existing surveillance imaging schedule is yet to be established. New models of follow up care are needed to demonstrate better patient outcomes in this patient cohort. There are indications that patient-reported outcome measures (PROMs) can contribute to improved survival and maintaining an optimal quality of life in other oncology populations. MATERIALS AND METHODS There are no standardised PROMs for the priority symptoms in glioblastoma patients, which can be used for evaluation in clinical care as a surrogate marker for disease progression. A broad set of symptoms were therefore initially identified in a targeted literature search and were further refined via Delphi methodology, with the aim to obtain consensus amongst a small expert panel involved in the care of glioblastoma patients. A three round Delphi email survey was conducted. Consensus was defined as 70% agreement. RESULTS Symptom and function constructs were assessed for relevance, relationship to disease and treatment, sensitivity to change, psychometric properties and patient acceptability. Consensus was reached on the red flag symptoms and symptom clusters to monitor, as well as the minimum severity thresholds needed to trigger an alert on an electronic symptom reporting system, which has been developed to allow patient self-reporting of symptoms during treatment. CONCLUSION The red flag symptoms to monitor, along with the symptom severity thresholds, informed an app-based symptom reporting system, which is currently being piloted in a feasibility study exploring triggered imaging using ePROMs. This has the potential to inform future clinical practice through development of patient reported biomarkers.

Development and validation of a novel patient-reported outcomes (PRO) measure for symptom burden in patients with cancer and COVID-19 infection.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 12113-12113
Author(s):  
Loretta A. Williams ◽  
Meagan Whisenant ◽  
Tito R. Mendoza ◽  
Donna Malveaux ◽  
Donna Griffin ◽  
...  
Keyword(s):  
Sleep Disturbance ◽  
Symptom Severity ◽  
Symptom Burden ◽  
Symptom Assessment ◽  
Median Number ◽  
Validity And Reliability ◽  
Specific Symptom ◽  
Patients With Cancer ◽  
Patient Reported ◽  
Health Rating

12113 Background: The symptom burden experienced by patients with cancer who contract the COVID-19 (C19) infection remains to be fully understood. To accurately assess this symptom burden, we developed a valid, reliable patient-reported outcome (PRO) measure of C19 symptoms combined with a known measure of cancer symptom burden. Methods: Within the institutional initiative on COVID-19 and cancer named Data-Driven Determinants for COVID-19 Oncology Discovery Effort (D3CODE), patients with cancer and PCR-positive C19 tests were invited to participate in this longitudinal study after providing consent. Pts completed the EQ-5D-5L and the 13 symptom severity and 6 interference items of the core MD Anderson Symptom Inventory (MDASI) plus 14 COVID-specific symptom items generated from literature and expert review. Items were measured on a 0-10 scale, 0 = none to 10 = worst imaginable symptom or interference. Demographic and disease information was collected. Psychometric procedures determined validity and reliability of the MDASI-COVID. Results: 600 pts enrolled, mean age 56.5y (range 20 to 91y). 59% female, 80% white. 78% solid tumors, 19% heme cancers. 12.5% required hospitalization for C19. Median number of days between positive C19 test and PRO completion was 17 days. Mean overall health rating on EQ-5D-5L was 78.3 (SD 19.6), best being 100. Highest mean (M) severity symptoms on the MDASI-COVID were fatigue (M 3.45, SD 2.17), drowsiness (M 2.50, SD 2.89), sleep disturbance (M 2.44, SD 2.99), malaise (M 2.37, SD 3.05), and distress (M 2.27, SD 2.90). Most severe (≥ 7) symptoms) reported were fatigue (21.3% of pts), change in taste (14.8%), change in smell (14.4%), malaise (14.3%), sleep disturbance (14.3%), and drowsiness (14%). Internal consistency (Cronbach α) of the 27 symptom items was 0.957, of the 6 interference items was 0.937. Mean severity of the 27 symptom items was significantly correlated with overall EQ-5D-5L health rating (correlation = -0.45, P < 0.0005), demonstrating concurrent validity. Mean symptom severity and interference showed known-group validity between patients who required C19 hospitalization (symptom M 2.32, SD 2.09; interference M 3.29, SD 3.02) and those who did not (symptom M 1.69, SD 1.85; interference M 2.20, SD 2.64) (symptom P 0.007; interference P 0.004). Conclusions: We have validated a novel PRO, the MDASI-COVID, to quantify the combined symptom burden in patients with cancer and COVID-19. This measure allows longitudinal evaluation of COVID-19 on cancer symptom burden and provide clinicians with an accurate tool for ongoing symptom assessment and management. Longitudinal analysis on long-term symptoms related to COVID-19 and cancer are ongoing.

The Symptom Burden of Chronic Myelogenous Leukemia (CML)

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 2408-2408
Author(s):  
Loretta A Williams ◽  
Patricia Ault ◽  
Xin Shelley Wang ◽  
Charles S. Cleeland ◽  
Tito R. Mendoza ◽  
...  
Keyword(s):  
Tyrosine Kinase ◽  
Symptom Severity ◽  
Performance Status ◽  
Symptom Burden ◽  
Patient Reported Outcome ◽  
Dry Mouth ◽  
Patient Treatment ◽  
Ecog Performance Status ◽  
Treatment Characteristics ◽  
Patient Reported

Abstract Symptom burden is the combined impact of all disease-related and therapy-related symptoms on one’s ability to function as one did before onset of disease or therapy. Lack of understanding of symptoms may result in failure to address symptoms and return patients to optimum functioning. This is critical for patients with chronic diseases who are receiving continuing therapy, such as patients with chronic myeloid leukemia (CML). Additionally patient-reported outcome measures are becoming primary endpoints in clinical trials to test results such as reduction in symptom burden that establish treatment benefits from the patient’s perspective. No patient-reported outcome measure for CML currently exists, and there is little understanding or knowledge of the symptom burden of CML and its treatment. The purpose of this study was to initially explore the symptom burden of CML. Methods: Retrospective analysis of 29 patients with CML who participated in two larger cross-sectional studies exploring cancer-related symptoms. Patients used the M. D. Anderson Symptom Inventory (MDASI) to rate the severity of their symptoms (13 items) and the degree to which their symptoms interfered with daily living (6 items) on a 0–10 scale. Results: Patient/treatment characteristics are summarized in Table 1. Table 1: Patient/Treatment Characteristics N=29 Mean SD Age 53.9 14.6 Highest Grade Completed 14.45 2.08 n % Sex–Male 17 58.6% Race–White, non-Hispanic 27 93.1% Employment Status–Employed or Homemaker 13 44.8% ECOG Performance Status–&lt; 2 21 72.4% Treatment Type Interferon-Based Therapy 9 31.0% Tyrosine Kinase Inhibitor 10 34.5% Mean global symptom severity was 1.86 (SD 1.76) and mean global interference was 1.79 (SD 2.05). Cronbach alpha for the symptom scores was 0.916 and for the interference scores was 0.922, indicating that the MDASI is reliable in this sample. The 6 most severe symptoms (mean severity score &gt; 2.5) were fatigue, drowsiness, lack of appetite, disturbed sleep, difficulty remembering things, and dry mouth. Symptoms interfered most with work and general activities. Mean symptom severity scores and standard deviations for the top most severe symptoms and most bothersome interference items are reported in Table 2. Table 2: Symptom and Interference Means and SD There was no significant difference in mean symptom severity or interference between patients receiving interferon-based therapies and patients receiving tyrosine kinase inhibitors. There were significant differences in mean symptom severity (p = .001) and interference (p &lt; .001) scores between patients with good (0 or 1) and poor (≥ 2) ECOG performance status. Preliminary analysis has encouraged us to investigate further relationships among the 13 symptom items, the 6 interference items, and demographic, disease, and treatment related factors. This further, more-detailed analysis will be presented. n Minimum Maximum Mean SD Symptom Item Fatigue 29 0 9 4.62 2.691 Drowsiness 29 0 10 3.00 3.151 Lack of Appetite 29 0 8 2.83 2.916 Sleep disturbance 29 0 10 2.66 2.595 Difficulty Remembering 29 0 7 2.62 2.162 Dry mouth 29 0 10 2.52 2.681 Interference Item Work 28 0 9 3.14 3.003 Activity 28 0 10 3.11 2.897 Conclusion: Methods for patients with CML to report symptom burden to clinicians and researchers are needed. Based on preliminary results, the MDASI is a reliable instrument that captures many symptoms of CML and differentiates between levels of severity of illness. Further work is ongoing to identify and add symptom items to the MDASI that will capture CML-specific and treatment-specific symptoms.

Clinician Report of Oral Oncolytic Symptoms and Adherence Obtained via a Patient-Reported Outcome Measure (PROM)

2019 ◽  
pp. 1-6
Author(s):  
Victoria R. Nachar ◽  
Karen Farris ◽  
Katie Beekman ◽  
Jennifer Griggs ◽  
Shannon Hough ◽  
...  
Keyword(s):  
Medication Adherence ◽  
Medical Record ◽  
Symptom Severity ◽  
Positive Impact ◽  
Symptom Burden ◽  
Patient Reported Outcome ◽  
Self Report ◽  
Oncolytic Therapy ◽  
Patient Reported ◽  
Oral Oncolytics

PURPOSE Patient-reported outcome measures (PROMs) for symptom monitoring during cancer therapy have been shown to have a positive impact on outcomes. These findings have primarily been shown for patients receiving intravenous chemotherapy. In addition, there is known discordance between physician reporting of symptoms and patient self-report. This initiative sought to describe patient-reported symptom burden and medication adherence and to indicate the degree of PROM results being discussed with the provider as indicated by documentation in the medical record for patients taking oral oncolytic therapy. METHODS The Michigan Oncology Quality Consortium (MOQC) PROM, which included symptom ratings, medication adherence, and patient confidence in self-management, was completed during outpatient visits and compared with corresponding data documented in the electronic medical record (EMR). RESULTS There were 82 completed PROMs. Approximately half included at least one symptom rated as severe (46%). Sixty-five percent of reported severe symptoms were documented in the EMR. Patient-reported moderate-to-severe pain was most likely to be documented in the EMR (100%), whereas patient-reported moderate-to-severe depression and anxiety were least likely to be documented (21%). Of the total symptoms documented, grading of symptom severity matched that of the patients’ own report for 11% of severe symptoms. Adherence to oral oncolytics was excellent for 63% of patients, and patient adherence was documented in 7% of provider notes. CONCLUSION Patients frequently reported moderate-to-severe symptoms, and approximately 40% of patients reported nonadherence. Clinician report (documented in the EMR) of the patient symptom burden, symptom severity, and adherence to oral oncolytic therapy was not consistent with the patients’ self-report. Use of a PROM for patients taking oral oncolytics has the opportunity to improve symptom management and medication adherence.

scholarly journals Longitudinal study of symptom burden in outpatients with advanced cancers based on electronic Patient-Reported Outcome (ePRO) platform: a single institution, prospective study protocol

BMJ Open ◽  
2020 ◽  
Vol 10 (11) ◽  
pp. e038223
Author(s):  
Lili Tang ◽  
Ying Pang ◽  
Yi He ◽  
Qiuling Shi ◽  
Xinkun Han ◽  
...  
Keyword(s):  
Study Protocol ◽  
Symptom Management ◽  
Depression Scale ◽  
Symptom Burden ◽  
Patient Reported Outcome ◽  
Critical Parameters ◽  
Advanced Lung Cancer ◽  
Optimal Time ◽  
Patient Reported

IntroductionAn electronic Patient-Reported Outcome (ePRO) platform is needed for implementing evidence-based symptom management in outpatients with advanced cancer. We describe the overall protocol and the methodology for measuring symptom burden, to provide critical parameters needed to implement symptom management on the ePRO platform.Methods and analysisThe study focusses on patients with advanced lung cancer, stomach cancer, oesophagus cancer, liver cancer, colorectal cancer or breast cancer. The primary outcome is the change of symptom burden. MD Anderson Symptom Inventory, and other PRO instruments (Insomnia Severity Index, Hospital Anxiety and Depression Scale, 9-item Patient Health Questionnaire and EuroQol-5 dimensions-5 levels version) were used. The secondary outcomes include feasibility of using ePRO, symptom-related quality of life, reasons for no improvement of symptoms, defining frequency of PRO assessments and cut-points, items for screening and management of comorbidity and satisfaction with ePRO platform in patients and health providers. After initial outpatient visit for baseline assessment, ePRO system will automatically send follow-up notification seven times over 4 weeks to patients. The characteristics and changing trajectory of symptoms of patients will be described. Parameters for using PROs, such as optimal time points for follow-up and cut-off point for alert will be determined. The feasibility of ePRO platform to track the changes of target symptoms in outpatients will be evaluated.Ethics and disseminationThe study protocol and related documents were approved by the Institutional Research Board (IRB) of Peking University Cancer Hospital on 13 February 2019 (2019YJZ07). The results of this study will be disseminated through academic workshops, peer-reviewed publications and conferences.Trial registration numberChiCTR1900023560.

scholarly journals Capturing PROMs in Oncology Through Consistent Nutrition Risk Identification: An Opportunity to Optimize Care by Embedding Patient Participation Facilitated by eHealth Tools

2021 ◽  
pp. 1-2
Author(s):  
Susana  Couto Irving 
Keyword(s):  
Outcome Measures ◽  
Patient Participation ◽  
Cancer Care ◽  
Clinical Care ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Risk Identification ◽  
Nutrition Status ◽  
Pancreatic Tumors ◽  
Patient Reported

Patient-reported outcome measures obtained via E-Health tools ease the assessment burden and encourage patient participation in cancer care (PaCC Study). <b>Background:</b> E-health based patient-reported outcome measures (PROMs) have the potential to automate early identification of both nutrition status and distress status in cancer patients while facilitating treatment and encouraging patient participation. This cross-sectional study assessed the acceptability, accuracy, and clinical utility of PROMs collected via E-Health tools among patients undergoing treatment for stomach, colorectal, and pancreatic tumors. <b>Results:</b> Eight-nine percent mostly, or completely, agreed that PROMs via tablets should be integrated in routine clinical care. Men were significantly more likely to require help completing the questionnaires than women (inv.OR = 0.51, 95% CI = (0.27, 0.95), p = 0.035). The level of help needed increased by 3% with each 1-year increase in age (inv. OR = 1.03, 95% CI = (1.01, 1.06), p = 0.013). On average, a patient tended to declare weight which was 0.84 kg inferior to their true weight (Bland and Altman 95 % CI = (–3.9, 5.6); SD: 2.41) and a height which was 0.95 cm superior to their true height (Bland and Altman 95 % CI = (−5, 3.1); SD 2.08). Patient-reported nutrition status was significantly associated with the professionally generated assessment (95% CI = (2.27, 4.15), p &#x3c; 0.001). As nutrition status declined, the distress score increased (95%CI = (0.88, 1.68), p &#x3c; 0.001). Of the patients, 48.8% who were both distressed and malnourished requested supportive care to address their problems. <b>Conclusion:</b> Patient-reported assessments utilizing E-health tools are an accurate and efficient method to encourage patient participation in cancer care while simultaneously ensuring that regular assessment of psycho-social and nutritional aspects of care are efficiently integrated in the daily clinical routine.

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