Use of patient-reported outcomes (PROs) to predict treatment outcomes in patients with advanced cancer.

2020 ◽  
Vol 38 (29_suppl) ◽  
pp. 186-186
Author(s):  
Aparna Raj Parikh ◽  
Emily E. Van Seventer ◽  
Madeleine Fish ◽  
Kathryn Fosbenner ◽  
Katie Kanter ◽  
...  

186 Background: PROs assessing quality of life (QOL) and physical symptoms often correlate with clinical outcomes in patients (pts) with cancer. Yet, data are lacking about the use of PROs to predict treatment response. We evaluated associations of baseline PROs with treatment response, healthcare use, and survival among pts with advanced gastrointestinal cancer. Methods: We prospectively enrolled pts with metastatic gastrointestinal cancer prior to initiating chemotherapy at Massachusetts General Hospital. At baseline (start of treatment), pts reported their QOL (Functional Assessment of Cancer Therapy General [FACT-G], subscales assess QOL across 4 domains: functional, physical, emotional, social well-being) and symptom burden (Edmonton Symptom Assessment System [ESAS]). Higher scores on FACT-G indicate better QOL, while higher scores on ESAS represent a greater symptom burden. We used regression models to examine associations of baseline PRO scores with treatment response (clinical benefit [CB] or progressive disease [PD] at the time of first scan based on clinical documentation), healthcare use (unplanned hospital admissions), and survival. Results: From 5/2019-3/2020, we enrolled 112 of 131 (85.5% enrollment) consecutive pts (median age = 62.8, 61.6% male, 45.5% pancreatobiliary cancer). For treatment response, 64.3% had CB and 35.7% had PD. Higher ESAS-physical (B = 1.04, p = .027) and lower FACT-G functional (B = 0.92, p = .038) scores at baseline were significant predictors of PD. On the specific ESAS items, pts who experienced PD were more likely to report moderate/severe poor well-being (57.9% vs 29.7%; p = .001), pain (44.7% vs 25.0%; p < .050), drowsiness (42.1% vs 20.3%; p = .024), and diarrhea (23.7% vs 4.7%; p = .008) at baseline. Lower FACT-G total (HR = 0.96, p = .003), FACT-G physical (HR = 0.89, p < .001), FACT-G functional (HR = 0.87, p < .001), and higher ESAS-physical (HR = 1.03, p = .028) scores at baseline were significantly associated with greater risk of hospital admission. Lower FACT-G total (HR = 0.96, p = .009), FACT-G emotional (HR = 0.87, p = .014), as well as higher ESAS-total (HR = 1.03, p = .018) and ESAS-physical (HR = 1.03, p = .040) scores at baseline were significantly associated with greater risk of death. Conclusions: We found that baseline PROs predict treatment response in pts with advanced cancer, namely physical symptoms and functional QOL, in addition to healthcare use and survival outcomes. These findings further support the use of PROs to predict important clinical outcomes, including the novel finding of treatment response.

Author(s):  
Oscar Corli ◽  
Giacomo Pellegrini ◽  
Cristina Bosetti ◽  
Luca Riva ◽  
Matteo Crippa ◽  
...  

Background: Cancer patients experience multiple symptoms throughout the course of the disease. We aimed to provide a comprehensive analysis of the symptom burden in patients with advanced cancer at admission to specialist palliative care (PC) services and seven days later to estimate the immediate impact of PC intervention. Patient and methods: The analysis was based on an observational, prospective, multicenter study (named DEMETRA) conducted in Italy on new patients accessing network specialist PC centers during the period May 2017–November 2017. The prevalence and intensity of symptoms were assessed at baseline and after seven days using three tools including the Edmonton Symptom Assessment System (ESAS). Results: Five PC centers recruited 865 cancer patients. Thirty-three different symptoms were observed at the baseline, the most frequent being asthenia (84.9%) and poor well-being (71%). The intensity of the most frequent symptoms according to ESAS ranged from 5.5 for asthenia to 3.9 for nausea. The presence and intensity of physical symptoms increased with increasing levels of anxiety and depression. After seven days, prevalence of nausea and breathlessness as well as intensity of almost all symptoms significantly decreased. Conclusions: The study confirmed the considerable symptom burden of patients with advanced cancer. PC intervention has significantly reduced the severity of symptoms, despite the patients’ advanced disease and short survival.


2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 100-100 ◽  
Author(s):  
Samantha M.C. Moran ◽  
Areej El-Jawahri ◽  
William F. Pirl ◽  
Lara Traeger ◽  
Pallavi Kumar ◽  
...  

100 Background: Patients with advanced cancer experience high rates of both physical and psychological morbidity, but data describing patients’ symptoms during hospital admissions are lacking. We sought to describe symptom burden in hospitalized patients with incurable solid and hematologic malignancies. Methods: We prospectively enrolled patients with incurable cancers admitted to the Massachusetts General Hospital from 9/1/2014 through 5/1/2015. Within the first week of their admission, we assessed physical and psychological symptoms using the Edmonton Symptom Assessment System-revised (ESAS-r). Beginning 11/15/2015, we also administered the Patient Health Questionnaire 4 (PHQ-4), scored categorically. Results: We enrolled 457 of 547 (84%) eligible patients. Participants (mean age=63.8 years; n=231, 51% female) had the following malignancies: gastrointestinal (n=149, 33%), lung (n=77, 17%), genitourinary (n=52, 11%), breast (n=33, 7%), hematologic (n=24, 5%), and other solid tumors (n=122, 27%). Using the ESAS-r, tiredness, drowsiness, anorexia, and pain were the most common severe symptoms. Using the PHQ-4, approximately one-third of participants screened positive for depression (91/271, 34%) and anxiety (86/273, 32%). Conclusions: Hospitalized patients with incurable solid and hematologic malignancies experience substantial physical and psychological symptoms. Most patients reported at least moderate tiredness, drowsiness, anorexia and pain. Additionally, a concerning proportion reported depression and anxiety. Our data demonstrate the need for efforts to alleviate the physical symptoms experienced by this population, while also seeking to understand and address their psychological needs. [Table: see text]


2020 ◽  
Vol 18 (6) ◽  
pp. 747-754 ◽  
Author(s):  
Daniel E. Lage ◽  
Areej El-Jawahri ◽  
Charn-Xin Fuh ◽  
Richard A. Newcomb ◽  
Vicki A. Jackson ◽  
...  

Background: National guidelines recommend regular measurement of functional status among patients with cancer, particularly those who are elderly or high-risk, but little is known about how functional status relates to clinical outcomes among hospitalized patients with advanced cancer. The goal of this study was to investigate how functional impairment is associated with symptom burden and healthcare utilization and clinical outcomes. Patients and Methods: We conducted a prospective observational study of patients with advanced cancer with unplanned hospitalizations at Massachusetts General Hospital from September 2014 through March 2016. Upon admission, nurses assessed patients’ activities of daily living (ADLs; mobility, feeding, bathing, dressing, and grooming). Patients with any ADL impairment on admission were classified as having functional impairment. We used the revised Edmonton Symptom Assessment System (ESAS-r) and Patient Health Questionnaire-4 to assess physical and psychological symptoms, respectively. Multivariable regression models were used to assess the relationships between functional impairment, hospital length of stay, and survival. Results: Among 971 patients, 390 (40.2%) had functional impairment. Those with functional impairment were older (mean age, 67.18 vs 60.81 years; P<.001) and had a higher physical symptom burden (mean ESAS physical score, 35.29 vs 30.85; P<.001) compared with those with no functional impairment. They were also more likely to report moderate-to-severe pain (74.9% vs 63.1%; P<.001) and symptoms of depression (38.3% vs 23.6%; P<.001) and anxiety (35.9% vs 22.4%; P<.001). Functional impairment was associated with longer hospital length of stay (β = 1.29; P<.001) and worse survival (hazard ratio, 1.73; P<.001). Conclusions: Hospitalized patients with advanced cancer who had functional impairment experienced a significantly higher symptom burden and worse clinical outcomes compared with those without functional impairment. These findings provide evidence supporting the routine assessment of functional status on hospital admission and using this to inform discharge planning, discussions about prognosis, and the development of interventions addressing patients’ symptoms and physical function.


2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 154-154
Author(s):  
Joy X. Jarnagin ◽  
Islam Baiev ◽  
Emily E. Van Seventer ◽  
Yojan Shah ◽  
Amirkasra Mojtahed ◽  
...  

154 Background: PROs assessing quality of life (QOL) and symptoms at a single timepoint frequently correlate with clinical outcomes in patients with cancer, yet efforts to understand how longitudinal changes in PROs can predict for treatment outcomes are lacking. In practice, oncologists often use changes in serum TMs (CEA and CA19-9) to monitor patients with GI cancer, and thus we sought to examine associations of 1-month changes in PROs and TMs with treatment response and survival outcomes among patients with advanced GI cancer. Methods: We prospectively enrolled patients with metastatic GI cancer prior to initiating chemotherapy at Massachusetts General Hospital from 5/2019-12/2020. At baseline (start of treatment) and 1-month later, we collected PROs (QOL [Functional Assessment of Cancer Therapy General {FACT-G}], physical symptoms [Edmonton Symptom Assessment System {ESAS}], and psychological symptoms [Patient Health Questionnaire-4 {PHQ-4}]) and TMs. We used regression models to examine associations of 1-month changes in PROs and TMs with treatment response (clinical benefit [defined as decreased or stable tumor burden] or progressive disease at the time of first scan) and survival outcomes (progression-free survival [PFS] and overall survival [OS]), adjusted for baseline values of each respective variable. Results: We enrolled 159 of 191 patients approached (83.2% enrollment); 134 had 1-month follow-up data (median age = 64 years [range: 28 to 84 years], 64.2% male, 46.3% pancreaticobiliary cancer). For treatment response, 63.4% had clinical benefit and 36.6% had progressive disease at the time of first scan (mean time to first scan = 2.01 months). Changes in PROs (ESAS-Total: OR = 0.97, p = 0.022; ESAS-Physical: OR = 0.96, p = 0.027; PHQ-4 depression: OR = 0.67, p = 0.014; FACT-G: OR = 1.07, p = 0.001), but not TMs (CEA: OR = 1.00, p = 0.836 and CA19-9: OR = 1.00, p = 0.796), were associated with clinical benefit at the time of first scan. Changes in ESAS-Total (HR = 1.03, p = 0.004), ESAS-Physical (HR = 1.03, p = 0.021), PHQ-4 depression (HR = 1.22, p = 0.042), FACT-G (HR = 0.97, p = 0.003), and CEA (HR = 1.00, p = 0.001) were predictors of PFS. Changes in ESAS-Total (HR = 1.03, p = 0.006) and ESAS-Physical (HR = 1.04, p = 0.015) were predictors of OS, but 1-month changes in TMs (CEA: HR = 1.00, p = 0.377 and CA19-9: HR = 1.00, p = 0.367) did not significantly predict for OS. Conclusions: We found that 1-month changes in PROs can predict for treatment response and survival outcomes in patients with advanced GI cancers. Notably, 1-month changes in CEA only correlated with PFS, while changes in CA19-9 did not significantly predict treatment response or survival outcomes. These findings highlight the potential for early changes in PROs to predict treatment outcomes while underscoring the need to monitor and address PROs in patients with advanced cancer. Clinical trial information: NCT04776837.


2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 227-227
Author(s):  
Kimberson Tanco ◽  
Marieberta Vidal ◽  
Joseph Anthony Arthur ◽  
David Hui ◽  
Gary B. Chisholm ◽  
...  

227 Background: Regular assessment of caregiver symptom burden during patient visits would allow prompt referral for their care. The ESAS is a multidimensional tool used in patients but not caregivers. The objectives of this study were to determine the feasibility of the ESAS in assessing caregiver symptoms defined as completing 9/12 items, assess caregiver-reported usefulness of its completion, determine the association of symptom scores between patients, caregivers and various clinical and psychosocial factors, and determine concurrent validity with the Zarit Burden Interview-12 (ZBI-12). Methods: A prospective study of 90 patient-primary caregiver dyads in an outpatient Supportive Care Center in a cancer center was conducted. The 12 item ESAS-FS was completed by the dyads with other measures of clinical and psychosocial factors [demographics, cancer diagnosis, co-morbidities, caregiving activities, prognostic index and patient’s performance status]. Results: The ESAS is a feasible tool to assess caregiver symptom burden with 90/90 caregivers [100%] completing at least 9/12 items; 66/90 caregivers [73%] found ESAS useful to report their symptom burden. A significant association was found between ESAS scores of caregivers and patients in depression [p < 0.01], psychosocial items [depression, anxiety, well-being, financial distress, spiritual pain; p < 0.01], and total symptom distress scores [p < 0.01]. Caregiver employment status [p = 0.03] and total caregiver activities [p = 0.04] were significantly associated with total caregiver ESAS scores. There was no significant association between patient and caregiver co-morbidities [p = 0.08], prognostic index [0.07] and performance status [p = 0.26] to total caregiver ESAS scores. Caregivers recommended certain physical symptoms such as pain and nausea may be eliminated. Concurrent validity with ZBI-12 was not achieved [r = 0.53, p = 0.74] suggesting that ESAS measured different caregiver dimensions. Conclusions: The ESAS is a feasible tool to measure caregiver symptoms and was found useful by caregivers. Further research is needed to modify the ESAS based on caregiver’s recommendations and further psychometric studies need to be conducted.


2021 ◽  
Vol 39 (15_suppl) ◽  
pp. 6560-6560
Author(s):  
Joy X. Jarnagin ◽  
Aparna Raj Parikh ◽  
Emily E. Van Seventer ◽  
Yojan Shah ◽  
Islam Baiev ◽  
...  

6560 Background: PROs assessing quality of life (QOL) and symptoms at a single timepoint frequently correlate with clinical outcomes in patients with cancer, yet efforts to understand how longitudinal changes in PROs can predict for treatment outcomes are lacking. In practice, oncologists often use changes in serum TMs (CEA and CA19-9) to monitor patients with GI cancer, and thus we sought to examine associations of 1-month changes in PROs and TMs with treatment response and survival outcomes among patients with advanced GI cancer. Methods: We prospectively enrolled patients with metastatic GI cancer prior to initiating chemotherapy at Massachusetts General Hospital from 5/2019-12/2020. At baseline (start of treatment) and 1-month later, we collected PROs (QOL [Functional Assessment of Cancer Therapy General {FACT-G}], physical symptoms [Edmonton Symptom Assessment System {ESAS}], and psychological symptoms [Patient Health Questionnaire-4 {PHQ-4}]) and TMs. We used regression models to examine associations of 1-month changes in PROs and TMs with treatment response (clinical benefit [defined as decreased or stable tumor burden] or progressive disease at the time of first scan) and survival outcomes (progression-free survival [PFS] and overall survival [OS]), adjusted for baseline values of each respective variable. Results: We enrolled 159 of 191 patients approached (83.2% enrollment); 134 had 1-month follow-up data (median age = 64 years [range: 28 to 84 years], 64.2% male, 46.3% pancreaticobiliary cancer). For treatment response, 63.4% had clinical benefit and 36.6% had progressive disease at the time of first scan (mean time to first scan = 2.01 months). Changes in PROs (ESAS-Total: OR = 0.97, p = 0.022; ESAS-Physical: OR = 0.96, p = 0.027; PHQ-4 depression: OR = 0.67, p = 0.014; FACT-G: OR = 1.07, p = 0.001), but not TMs (CEA: OR = 1.00, p = 0.836 and CA19-9: OR = 1.00, p = 0.796), were associated with clinical benefit at the time of first scan. Changes in ESAS-Total (HR = 1.03, p = 0.004), ESAS-Physical (HR = 1.03, p = 0.021), PHQ-4 depression (HR = 1.22, p = 0.042), FACT-G (HR = 0.97, p = 0.003), and CEA (HR = 1.00, p = 0.001) were predictors of PFS. Changes in ESAS-Total (HR = 1.03, p = 0.006) and ESAS-Physical (HR = 1.04, p = 0.015) were predictors of OS, but 1-month changes in TMs (CEA: HR = 1.00, p = 0.377 and CA19-9: HR = 1.00, p = 0.367) did not significantly predict for OS. Conclusions: We found that 1-month changes in PROs can predict for treatment response and survival outcomes in patients with advanced GI cancers. Notably, 1-month changes in CEA only correlated with PFS, while changes in CA19-9 did not significantly predict treatment response or survival outcomes. These findings highlight the potential for early changes in PROs to predict treatment outcomes while underscoring the need to monitor and address PROs in patients with advanced cancer.


2020 ◽  
Author(s):  
Oscar Corli ◽  
Giacomo Pellegrini ◽  
Cristina Bosetti ◽  
Luca Riva ◽  
Matteo Crippa ◽  
...  

Abstract Background: Cancer patients experience a number of symptoms throughout the course of the disease. We aimed to provide a comprehensive analysis of the symptom burden in patients with advanced cancer at admission to specialist palliative care (PC) services and seven days later, to estimate the immediate impact of PC intervention.Patient and methods: The analysis was based on an observational, prospective, multicenter study (named DEMETRA) conducted in Italy to outline the profile of patients, families and PC services in different care settings (hospital, hospice and home care). The prevalence and intensity of symptoms were assessed using three tools, including the Edmonton Symptom Assessment System (ESAS).Results: Five PC centers recruited 865 cancer patients. Thirty-three different symptoms were observed at baseline, the most frequent being asthenia (85%) and lack of appetite (71%). Two-thirds of patients experienced six to twelve simultaneous symptoms. The intensity of the most frequent symptoms according to ESAS varied from 5.5 for asthenia to 3.9 for nausea. The presence and intensity of physical symptoms increased with increasing levels of anxiety and depression. After seven days, prevalence decreased significantly only for nausea and breathlessness, while intensity diminished significantly for almost all symptoms. At admission we noted a correlation between patients' symptoms and the care setting. After one week, the symptom intensity was uniformly reduced in all settings.Conclusions: The study confirmed the considerable symptom burden of patients with advanced cancer. PC intervention significantly lessened the severity of symptoms, despite the patients’ advanced disease and short survival.


2004 ◽  
Vol 2 (3) ◽  
pp. 243-253 ◽  
Author(s):  
CHERYL L. NEKOLAICHUK ◽  
EDUARDO BRUERA

Objective:The purpose of this study was to gather validity evidence for an innovative experience of hope scale, theHope Differential-Short (HDS), and evaluate its clinical utility for assessing hope in advanced cancer patients.Methods:A consecutive sampling approach was used to recruit 96 patients from an inpatient tertiary palliative care unit and three hospice settings. Each participant completed an in-person survey interview, consisting of the following measures: HDS (nine items), Herth Hope Index (HHI), hope visual analog scale (Hope-VAS) and Edmonton Symptom Assessment System (ESAS).Results:Using factor analytic procedures, a two-factor structure for the HDS was identified, consisting ofauthentic spirit(Factor I) andcomfort(Factor II). The HDS factors had good overall internal consistency (α = 0.83), with Factor I (α = 0.83) being higher than Factor II (α = 0.69). The two factors positively correlated with the HHI, Hope-VAS, and one of the ESAS visual analog scales, well-being (range: 0.38 to 0.64) and negatively correlated with depression and anxiety, as measured by the ESAS (range: −0.25 to −0.42).Significance of results:This is the first validation study of the HDS in advanced cancer patients. Its promising psychometric properties and brief patient-oriented nature provide a solid initial foundation for its future use as a clinical assessment measure in oncology and palliative care. Additional studies are warranted to gather further validity evidence for the HDS before its routine use in clinical practice.


2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Jarrin Penny ◽  
Fabio R Salerno ◽  
Lisa Hur ◽  
Christopher McIntyre

Abstract Background and Aims High flux dialysis membranes sufficiently remove smaller sized uremic toxins however, the accumulation and retention of larger middle molecular weight toxins, which are associated with chronic inflammation, cardiovascular disease and suboptimal outcomes are poorly cleared. The recent advent of medium-cut-off dialysis membranes, labelled “expanded dialysis” (HDx) are permeable to molecules of larger size responsible for poor clinical outcomes. However, it remains unclear if HDx can directly impact the symptoms associated with hemodialysis (HD). Symptom burden plays a significant role in quality of life (QOL) and mortality rates in the HD population. The London Evaluation of Illness (LEVIL), an application-based platform has been developed to measure patient reported outcomes (PROM). In comparison to cross-sectional PROM’s, LEVIL more accurately represents the fluctuations in daily symptoms and the impact of intervention. LEVIL evaluates general well-being, energy, sleep, appetite, pain and breathing, all of which are outcomes of interest on symptom burden in chronic kidney disease. Our aim was to determine if HDx therapy had any effect on symtoms/QOL domains using LEVIL. Method 28 patients from two dialysis centers in London Ontario were consented to participate. Patients were required to be over 18 years of age and on conventional thrice weekly maintenance HD for at least three months. 23 participants completed study and analyzed (five lost for various reasons). Baseline (BL) symptom characteristics were obtained while using high flux membrane for two weeks. Symptoms continued to be measured throughout the 12 weeks of HDx therapy two-three times weekly using LEVIL. Laboratory biomarkers including beta-2 microglobulin and free-light chains were collected at baseline and after 12 weeks of HDx therapy. Results Patients were stratified into tertiles (high/middle/low) using mean values of BL symptoms scores in each domain (wellbeing, energy, sleep, appetite, pain, breathing). Those in the high BL group were labeled as “control”. Low and middle BL measures were further stratified into responders vs. non-responders (responders were considered to have a 50% increase in any symptom domain by ≥50%). Of those domains which responded to HDx, 76% also had low BL scores with 27% having middle BL scores. General wellbeing, energy and sleep were domains with the greatest response reaching statistical significance after eight weeks of therapy. HDx had limited effect on appetite, pain and breathing. Although stratification was per domain, overall, 74% of the population studied did respond in at least one domain, with some responding in as many as five. Conclusion HDx using Theranova (Baxter) shows the most benefit in domains with low BL measures. Additionally, not everyone who had low BL scores responded after 12 weeks of therapy, leaving us to question whether HDx may have a latent effect in some individuals/populations. Those who had no response to therapy in certain domains also had greater baseline quality of life respectively. This information may assist in decision making/rationale for the utilization and implementation of such therapy. Although more work is required to further stratify symptoms in relation to demographic/biochemical finding and clinical outcomes. It is evident that HDx improves patient reported symptoms and QOL.


2013 ◽  
Vol 23 (5) ◽  
pp. 971-978 ◽  
Author(s):  
Lori Spoozak ◽  
Hsien Seow ◽  
Ying Liu ◽  
Jason Wright ◽  
Lisa Barbera

ObjectiveThe Palliative Performance Scale (PPS), which measures performance status (100 = best performance to 0 = dead), and the Edmonton Symptom Assessment System (ESAS), which measures severity of 9 symptoms, are routinely collected at ambulatory cancer visits in Ontario. This study describes the trajectory of scores in patients with gynecologic cancer in the last 6 months of life.MethodsAn observational study was conducted between 2007 and 2010. Patients had ovarian/fallopian tube, uterine, and cervical cancer and required 1 or more PPS or ESAS assessment in the 6 months before death. Outcomes were the average PPS and ESAS scores per week before death. Using logistic regression, we analyzed the odds ratio of reporting a moderate to severe score for each symptom.ResultsSeven hundred ninety-five (PPS) and 1299 (ESAS) patients were included. The average PPS score started at 70 and ended at 30, rapidly declining in the last 2 months. For ESAS symptoms, drowsiness, decreased well-being, lack of appetite, and tiredness increased in severity closer to death and were prevalent in more than 70% of patients in the last week of life. Patients with cervical cancer had increased odds of moderate to severe pain (1.74; 95% confidence interval, 1.30–2.32) compared with ovarian cancer.ConclusionsTrajectories of mean performance status had not reached the “end-of-life” phase until 1 week before death. A large proportion of the gynecologic cancer patients reported moderate to severe symptom scores as death approached. Pain was uniquely elevated in the cervical cancer cohort as death approached. Adequately managing the symptom burden appears to be a significant issue in end-of-life gynecologic care.


Sign in / Sign up

Export Citation Format

Share Document