Are real-world patient-reported outcomes associated with survival in patients with advanced pancreatic cancer?

205 Background: Advanced pancreatic cancer (APC) patients often have a substantial symptom burden. In Ontario, patients visiting cancer clinics routinely complete the Edmonton Symptom Assessment Scale (ESAS), which screens for 9 symptoms (scale: 0-10). Using ESAS, we explored the association between baseline patient-reported outcomes and overall survival (OS). Methods: APC Patients with ESAS records prior to receiving publicly-funded drugs from November 2008 to March 2016 were identified from Cancer Care Ontario’s New Drug Funding Program and Symptom Management databases. We examined 3 baseline composite ESAS scores: Total Symptom Distress Score (TSDS: all 9 symptoms), Physical Symptom Score (PHS: 6/9 symptoms), and Psychological Symptom Score (PSS: 2/9 symptoms); Composite scores greater than a threshold (defined as number of symptoms in composite score multiplied by clinically relevant score (≥4)) were categorized as High Symptom Burden (TSDS ≥ 36, PHS ≥ 24, PSS ≥ 8). The primary endpoint, OS, was assessed using Kaplan-Meier. Multivariable Cox models were used to adjust for age, gender, income, prior therapies (surgery, adjuvant gemcitabine, radiation), and Charlson's comorbidity. Analysis was repeated in a sub-cohort with identifiable ECOG status and stage. Results: We identified 2,199 APC patients (mean age 64 years, 55% male) with ESAS records prior to receiving gemcitabine (54%), FOLFIRINOX (40%) or gemcitabine/nab-paclitaxel (6%). Crude median survival was 4.5 and 7.3 months for patients with high and low TSDS burden, respectively (HR = 1.50, 95% CI: 1.36, 1.66). After adjustment with multivariable Cox model, high TSDS burden was associated with lower OS (HR = 1.47, 95% CI: 1.33, 1.63). Similar trends were observed for PHS and PSS. When adjusting for both PHS and PSS in a Cox model, only the effect of PHS remained significant. In the sub-cohort (n = 393), high TSDS burden (HR = 1.34, 95% CI: 1.04, 1.73) was associated with lower OS, after adjusting for ECOG and stage. Conclusions: Among APC patients, a higher burden of patient-reported symptoms, via ESAS, at baseline was associated with reduced OS. The effect was prominent for physical symptoms, even after adjusting for treatment, stage and ECOG.

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Patient Reported Outcomes in Penile Cancer

10.21203/rs.3.rs-958776/v1 ◽

2021 ◽

Author(s):

Irini Youssef ◽

Aasha Hoogland ◽

Jad Chahoud ◽

Philippe Spiess ◽

Heather Jim ◽

...

Keyword(s):

Symptom Score ◽

Penile Cancer ◽

Patient Reported Outcomes ◽

Recurrent Disease ◽

Symptom Burden ◽

Symptom Assessment ◽

Patient Reports ◽

Patient Reported ◽

Edmonton Symptom Assessment Scale ◽

Partial Penectomy

Abstract Objective: Patient reports of their symptom burden (i.e., patient-reported outcomes or PROs) have been shown to direct clinicians’ ability to personalize care and improve outcomes. A disciplined assessment of PRO in the population of patients with penile cancer (PeCa) has not previously been undertaken. Our center has both a significant cadre of patients with PeCa and a significant experience with a well-established PRO: the Edmonton Symptom Assessment Scale (ESAS).Methods: After IRB approval, we screened ESAS surveys of 14,781 patients completed between 2/2017 and 2/2021. Of these, those with PeCa were divided into three cohorts: (A) Those after any partial penectomy procedure without lymph node dissection (LND); (B) Those after partial penectomy procedure with LND; and (C) Those after total penectomy and LND. Patients with recurrent disease were analyzed separately. ESAS scores were collated and compared both by individual symptom and cumulatively.Results: 22 PeCa patients completed 122 ESAS surveys in this time and are included in this analysis: a median of 4 ESAS surveys (mean=5, range=1-19) were completed by each patient. The symptom with the highest median ESAS score was Tiredness (3.00). Patients with recurrent disease had the highest cumulative symptom score (median score = 30). Patients after total penectomy with LND had a higher cumulative symptom score (14.4) than those with partial penectomy and LND (7.9).Conclusions: PROs provide an insight into the morbidity of therapies for PeCa, and the most symptoms are reported by patients with recurrent disease.

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Are population‐based patient‐reported outcomes associated with overall survival in patients with advanced pancreatic cancer?

Cancer Medicine ◽

10.1002/cam4.2704 ◽

2019 ◽

Vol 9 (1) ◽

pp. 215-224 ◽

Cited By ~ 1

Author(s):

Wei Fang Dai ◽

Jaclyn Beca ◽

Helen Guo ◽

Wanrudee Isaranawatchai ◽

Deborah Schwartz ◽

...

Keyword(s):

Pancreatic Cancer ◽

Overall Survival ◽

Patient Reported Outcomes ◽

Advanced Pancreatic Cancer ◽

Population Based ◽

Patient Reported

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Utilizing patient reported outcomes for patients recieving oral chemotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.8_suppl.190 ◽

2017 ◽

Vol 35 (8_suppl) ◽

pp. 190-190 ◽

Cited By ~ 1

Author(s):

Emily R. Mackler ◽

Kathleen W. Beekman ◽

Laura Bushey ◽

Anne Gentz ◽

Kathleen Davis ◽

...

Keyword(s):

Side Effects ◽

Side Effect ◽

Patient Reported Outcomes ◽

Symptom Burden ◽

Symptom Assessment ◽

Oral Chemotherapy ◽

Severe Side Effect ◽

Management Support ◽

Patient Reported ◽

Edmonton Symptom Assessment Scale

190 Background: Management of oral chemotherapy presents many challenges to oncology practitioners. The purpose of this study is to describe how incorporation of patient reported outcomes (PRO) for patients receiving oral chemotherapy can identify those patients who are experiencing moderate to severe symptom burden and nonadherence. Methods: As part of a statewide quality collaborative, we wished to improve our monitoring of patients receiving oral chemotherapy. The quality collaborative created a PRO assessment that includes a revised Edmonton Symptom Assessment Scale (ESAS), a single-item adherence question, reasons for nonadherence, the patient’s most bothersome symptom and questions related to patient confidence. Our medical assistants provide the assessment to the patient before each appointment. Results: Patients completing the PRO during the first 3 months (7/7/16 – 9/27/16) were evaluated. We had 32 assessments completed by 23 patients. The oral chemotherapy prescribed were capecitabine (48%), erlotinib (13%), temozolomide (13%), and not recorded (26%). Of the 29 completed ESAS assessments, 72% included at least 1 moderate side effect, and 48% included at least 1 severe side effect. 29% of patients reported low-moderate confidence to self-manage their symptoms. Less than excellent adherence (<80% adherence) was reported in 30% of patients with the most commonly reported reason being related to side effects or concerns about side effects. Conclusions: Use of PROs in our oral chemotherapy population identified a large proportion of patients experiencing moderate to severe side effects. Further assessment of how this compares to what patients report to their oncologist during their visits will be reviewed. In addition, we found that approximately 30% of our patients are nonadherent to their oral chemotherapy. This is consistent with recent publications. We plan to continue assessing patient outcomes and utilizing the data we collect to improve patient self-management support.

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Implementing a Method for Evaluating Patient-Reported Outcomes Associated With Oral Oncolytic Therapy

Journal of Oncology Practice ◽

10.1200/jop.2016.018390 ◽

2017 ◽

Vol 13 (4) ◽

pp. e395-e400 ◽

Cited By ~ 4

Author(s):

Emily Mackler ◽

Laura Petersen ◽

Jane Severson ◽

Douglas W. Blayney ◽

Lydia L. Benitez ◽

...

Keyword(s):

Quality Of Care ◽

Patient Reported Outcomes ◽

Assessment Tool ◽

Symptom Burden ◽

Oncolytic Therapy ◽

Patients With Cancer ◽

Patient Reported ◽

Edmonton Symptom Assessment Scale ◽

Oral Oncolytics

Introduction: The paradigm shift in health care toward value-based reimbursement has brought emphasis to providing better quality of care to patients with chronic diseases, including patients with cancer. In accordance with providing better quality of care to patients, there has been a growing interest in evaluating quality of life through patient-reported outcomes (PROs). The revised Edmonton Symptom Assessment Scale (ESAS-r) is a tool that can be used to assess PROs and has been validated for use in patients with cancer. This initiative sought to use this standard assessment tool to acquire PROs concerning symptom burden from patients prescribed oral oncolytics. Patients and Methods: Eight oncology practices in the state of Michigan used a modified ESAS-r to evaluate symptom burden of patients prescribed oral oncolytics before each outpatient visit. Thirteen symptoms were categorized as mild (0 to 3), moderate (4 to 6), or severe (7 to 10). Results: A total of 1,235 modified ESAS-r surveys were collected and analyzed; 82.5% of symptoms were categorized as mild, 11.9% of symptoms were categorized as moderate, and 5.6% of symptoms were categorized as severe. Conclusion: PROs can be evaluated through the use of a standardized tool, such as the ESAS-r, in oncology patients receiving oral oncolytic therapy. Implementing such a tool in both community and academic practices is feasible and may facilitate improvements in the quality of care.

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Patient-reported symptoms from patients with advanced pancreatic cancer undergoing gemcitabine-based chemotherapy.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.4_suppl.370 ◽

2012 ◽

Vol 30 (4_suppl) ◽

pp. 370-370 ◽

Cited By ~ 1

Author(s):

Xin Shelley Wang ◽

David R. Fogelman ◽

Qiuling Shi ◽

Cathy Eng ◽

Raza H Bokhari ◽

...

Keyword(s):

Pancreatic Cancer ◽

Performance Status ◽

Advanced Pancreatic Cancer ◽

Symptom Burden ◽

Poor Performance Status ◽

Opioid Use ◽

Mixed Effect ◽

Symptom Profile ◽

Patient Reported ◽

Over Time

370 Background: The symptoms reported by patients being treated for advanced pancreatic cancer (PC) could be driven by disease and treatment. Few clinical studies have addressed the interaction between disease, treatment, and symptom burden. We conducted a longitudinal study tracking multiple symptoms to provide an evidence-based symptom profile for patients with advanced PC receiving gemcitabine-based chemotherapy. Methods: From start of the first chemotherapy cycle (baseline), patients rated symptoms weekly during chemotherapy via the M. D. Anderson Symptom Inventory (MDASI), then continued symptom assessment every two weeks for up to 40 weeks. Longitudinal symptom responses were analyzed by mixed-effect modeling. Results: Among 100 PC patients enrolled, 87% were treatment-naïve. The median age was 65 yrs old (range 35-85). Half of the sample was female; 32% received opioids for severe pain. The three most severe MDASI symptoms at baseline were fatigue, lack of appetite, and pain. Poor performance status and opioid use were significantly related to severity of these baseline symptoms (all P<.05%). The marginal means of severity for these three symptoms were significantly higher over time in patients who discontinued therapy < 9 weeks, compared with those who remained on study for 26-40 weeks (fatigue, P=.028; lack of appetite, P=.012; pain, P<.0001). Over time, lack of appetite improved significantly (P=.039), while pain and fatigue tended to worsen (P=NS). Compared with patients who remained on study, patients discontinued treatment earlier had significantly worse baseline pain (P=.005) and a non-significant trend towards greater fatigue and lack of appetite. Conclusions: Our results suggest that standard gemcitabine-based chemotherapy plus active palliative care for advanced PC was associated with significant improvement in appetite. However, worsening fatigue suggests a need to provide active intervention to minimize this symptom for PC patients. Patients suffering from greater symptom burden at baseline and overtime, seems consistent with greater disease burden, may be expected to discontinue treatment earlier.

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Patient-Reported Outcomes as a Component of the Primary Endpoint in a Double-Blind, Placebo-Controlled Trial in Advanced Pancreatic Cancer

Journal of Pain and Symptom Management ◽

10.1016/j.jpainsymman.2008.02.007 ◽

2009 ◽

Vol 37 (2) ◽

pp. 135-143 ◽

Cited By ~ 14

Author(s):

S. Gail Eckhardt ◽

Peter De Porre ◽

David Smith ◽

Joan Maurel ◽

William P. Steward ◽

...

Keyword(s):

Pancreatic Cancer ◽

Primary Endpoint ◽

Patient Reported Outcomes ◽

Controlled Trial ◽

Advanced Pancreatic Cancer ◽

Double Blind ◽

Double Blind Placebo ◽

Patient Reported

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Measuring patient-reported outcomes to improve cancer care in Canada: an analysis of provincial survey data

Current Oncology ◽

10.3747/co.25.3995 ◽

2018 ◽

Vol 25 (2) ◽

pp. 176 ◽

Cited By ~ 10

Author(s):

K. Tran ◽

S. Zomer ◽

J. Chadder ◽

C. Earle ◽

S. Fung ◽

...

Keyword(s):

Cancer Treatment ◽

Cancer Care ◽

Patient Reported Outcomes ◽

Symptom Burden ◽

Symptom Assessment ◽

Physical Symptoms ◽

Assessment System ◽

System Level ◽

Care Providers ◽

Patient Reported

Patient-reported outcomes measures (proms) are an important component of the shift from disease-centred to person-centred care. In oncology, proms describe the effects of cancer and its treatment from the patient perspective and ideally enable patients to communicate to their providers the physical symptoms and psychosocial concerns that are most relevant to them. The Edmonton Symptom Assessment System–revised (esas-r) is a commonly used and validated tool in Canada to assess symptoms related to cancer. Here, we describe the extent to which patient reported outcome programs have been implemented in Canada and the severity of symptoms causing distress for patients with cancer.As of April 2017, 8 of 10 provinces had implemented the esas-r to assess patient-reported outcomes. Data capture methods, the proportion of cancer treatment sites that have implemented the esas-r, and the time and frequency of screening vary from province to province. From October 2016 to March 2017 in the 8 reporting provinces, 88.0% of cancer patients were screened for symptoms. Of patients who reported having symptoms, 44.3% reported depression, with 15.5% reporting moderate-to-high levels; 50.0% reported pain, with 18.6% reporting moderate-to-high levels; 56.2% reported anxiety, with 20.4% reporting moderate-to-high levels; and 75.1% reported fatigue, with 34.4% reporting moderate-to-high levels.There are some notable areas in which the implementation of proms could be improved in Canada. Findings point to a need to increase the number of cancer treatment sites that screen all patients for symptoms; to standardize when and how frequently patients are screened across the country; to screen patients for symptoms during all phases of their cancer journey, not just during treatment; and to assess whether giving cancer care providers real-time patient-reported outcomes data has led to appropriate interventions that reduce the symptom burden and improve patient outcomes. Continued measurement and reporting at the system level will allow for a better understanding of progress in proms activity over time and of the areas in which targeted quality improvement efforts could ensure that patient symptoms and concerns are being addressed.

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