Patient-Reported Outcomes of Pain and Related Symptoms in Integrative Oncology Practice and Clinical Research: Evidence and Recommendations

Pain is a primary concern among patients with cancer and cancer survivors. Integrative interventions such as acupuncture, massage, and music therapy are effective nonpharmacologic approaches for cancer pain with low cost and minimal adverse events. Patient-reported outcomes (PROs) that have been validated in many clinical and research settings can be used to evaluate pain intensity, associated symptom burden, and quality of life. Clearly defined, reliable PROs can improve patient satisfaction and symptom control. As integrative oncology continues to evolve and expand, cancer-related pain PROs must be standardized to accurately guide clinicians and researchers. Well-validated pain PROs, such as the Brief Pain Inventory, are among the most commonly used for pain intensity assessment. Multiple symptom assessment tools such as the MD Anderson Symptom Inventory, the Memorial Symptom Assessment Scale, the Edmonton Symptom Assessment System, and the Patient-Reported Outcomes–Common Terminology Criteria for Adverse Events measurement system can also capture pain-associated symptom burden. Electronic PROs provide flexibility in collecting and analyzing PRO data. Clinical trials using carefully selected PROs and rigorous statistical analysis plans are fundamental to conducting high-quality integrative oncology research and promoting utilization of effective integrative interventions to improve patient outcomes. In this review, we aim to summarize current, validated PROs specific to cancer-related pain to aid integrative oncology clinicians and researchers in patient care and in study design and implementation.

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Long-term patient reported outcomes following radiation therapy for oropharyngeal cancer: A symptom assessment study in patients >65 years old.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.15_suppl.e21611 ◽

2017 ◽

Vol 35 (15_suppl) ◽

pp. e21611-e21611 ◽

Cited By ~ 1

Author(s):

Salman Ali Eraj ◽

Mona K Jomaa ◽

Crosby Douglas Rock ◽

Abdallah Mohamed ◽

Adam S. Garden ◽

...

Keyword(s):

Radiation Therapy ◽

Head And Neck ◽

Oropharyngeal Cancer ◽

Symptom Burden ◽

Symptom Assessment ◽

Distinct Pattern ◽

Assessment Tools ◽

Dry Mouth ◽

Patient Reported

e21611 Background: Given the potential for older patients (pts) to experience exaggerated toxicity and symptoms, this study was performed to characterize pt reported outcomes (PROs) in older pts following definitive radiation therapy (RT) for oropharyngeal cancer (OPC). Methods: Disease-free head and neck cancer survivors ( > 6 mos. since tx) were eligible for participation in a questionnaire-based study. Participants completed the MD Anderson Symptom Inventory-Head and Neck module (MDASI-HN). Those who had been treated for OPC with definitive RT (w/ or w/o systemic therapy) and were > 65 y/o at time of RT were included. Individual and overall symptom severity and clinical variables were analyzed. Results: Of the 79 participants analyzed, 82% were male, 95% white, 41% T3/4 disease, 39% RT alone, 27% induction chemotherapy, 52% concurrent, and 18% both, and 96% IMRT. Median age at the time of RT was 71 yrs. (range: 65-85); median time from end of RT to MDASI-HN completion was 46 mos. (2/3 > 24 mos.). The top 5 MDASI-HN items rated most severe in terms of mean (±SD) ratings (0-10 scale) were dry mouth (3.48±2.95), taste (2.81±3.29), swallowing (2.59±2.96), mucus in mouth/throat (2.04±2.68), and choking (1.30±2.38) reported at moderate to severe levels (≥5) by 35, 29, 29, 18, and 13%, respectively. Thirty-nine % reported none (0) or no more than mild (1-4) symptoms across all 22 MDASI-HN symptoms items, and 38% had at least one item rated as severe (≥7). Hierarchal cluster analysis resulted in 3 patient groups: 1) ~75% with generally no to moderate symptom burden, 2) ~25% with moderate to severe ratings for a subset of classically RT-related symptoms (e.g. dry mouth, mucus, swallow, taste), and 3) only 2 pts with severe ratings of nearly all items. Subgroup comparisons will be presented. Conclusions: The overall long-term symptom burden seen in this older OPC cohort was largely favorable, yet a higher symptom group (~25%) with a distinct pattern of mostly local symptoms was identified. We have implemented the routine use of symptom assessment tools as part of OPC survivorship programs and plan to explore age-dose-modeling of symptoms identified and associated normal structures.

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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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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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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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Integrative Oncology Consultations Delivered via Telehealth in 2020 and In-Person in 2019: Paradigm Shift During the COVID-19 World Pandemic

Integrative Cancer Therapies ◽

10.1177/1534735421999101 ◽

2021 ◽

Vol 20 ◽

pp. 153473542199910 ◽

Cited By ~ 1

Author(s):

Santhosshi Narayanan ◽

Gabriel Lopez ◽

Catherine Powers-James ◽

Bryan M Fellman ◽

Aditi Chunduru ◽

...

Keyword(s):

Symptom Management ◽

Healthy Lifestyle ◽

Symptom Burden ◽

Symptom Assessment ◽

Mobile Technologies ◽

Cancer Type ◽

Integrative Oncology ◽

Cancer Symptoms ◽

Patient Reported ◽

Edmonton Symptom Assessment Scale

Background: The COVID-19 pandemic has catalyzed the use of mobile technologies to deliver health care. This new medical model has benefited integrative oncology (IO) consultations, where cancer patients are counseled about healthy lifestyle, non-pharmacological approaches for symptom management, and addressing questions around natural products and other integrative modalities. Here we report the feasibility of conducting IO physician consultations via telehealth in 2020 and compare patient characteristics to prior in-person consultations conducted in 2019. Methods: An integrated EHR-telemedicine platform was used for IO physician consultations. As in the prior in-person visits, patients completed pre-visit patient-reported outcome (PRO) assessments about common cancer symptoms [modified Edmonton Symptom Assessment Scale, (ESAS)], Measure Yourself Concerns and Wellbeing (MYCaW), and the PROMIS-10 to assess quality of life (QOL). Patient demographics, clinical characteristics, and PROs for new telehealth consultation in 2020 were compared to new in-person consultations in 2019 using t-tests, chi-squared tests, and -Wilcoxon rank-sum test. Results: We provided telehealth IO consultations to 509 new patients from April 21, 2020, to October 21, 2020, versus 842 new patients in-person during the same period in 2019. Most were female (77 % vs 73%); median age (56 vs 58), and the most frequent cancer type was breast (48% vs 39%). More patients were seeking counseling on herbs and supplements (12.9 vs 6.8%) and lifestyle (diet 22.7 vs 16.9% and exercise 5.2 vs 1.8%) in the 2020 cohort than 2019, respectively. The 2020 telehealth cohort had lower symptom management concerns compared to the 2019 in-person cohort (19.5 vs 33.1%). Conclusions: Delivering IO consultations using telehealth is feasible and meets patients’ needs. Compared to patients seen in-person during 2019, patients having telehealth IO consultations in 2020 reported lower symptom burden and more concerns about lifestyle and herbs and supplements. Additional research is warranted to explore the satisfaction and challenges among patients receiving telehealth IO care.

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Electronic patient-reported outcomes and machine learning in predicting immune-related adverse events of immune checkpoint inhibitor therapies

BMC Medical Informatics and Decision Making ◽

10.1186/s12911-021-01564-0 ◽

2021 ◽

Vol 21 (1) ◽

Author(s):

Sanna Iivanainen ◽

Jussi Ekstrom ◽

Henri Virtanen ◽

Vesa V. Kataja ◽

Jussi P. Koivunen

Keyword(s):

Machine Learning ◽

Early Detection ◽

Adverse Events ◽

Cancer Patients ◽

Immune Checkpoint ◽

Patient Reported Outcomes ◽

Prediction Models ◽

Accuracy Score ◽

Patient Reported ◽

Auc Value

Abstract Background Immune-checkpoint inhibitors (ICIs) have introduced novel immune-related adverse events (irAEs), arising from various organ systems without strong timely dependency on therapy dosing. Early detection of irAEs could result in improved toxicity profile and quality of life. Symptom data collected by electronic (e) patient-reported outcomes (PRO) could be used as an input for machine learning (ML) based prediction models for the early detection of irAEs. Methods The utilized dataset consisted of two data sources. The first dataset consisted of 820 completed symptom questionnaires from 34 ICI treated advanced cancer patients, including 18 monitored symptoms collected using the Kaiku Health digital platform. The second dataset included prospectively collected irAE data, Common Terminology Criteria for Adverse Events (CTCAE) class, and the severity of 26 irAEs. The ML models were built using extreme gradient boosting algorithms. The first model was trained to detect the presence and the second the onset of irAEs. Results The model trained to predict the presence of irAEs had an excellent performance based on four metrics: accuracy score 0.97, Area Under the Curve (AUC) value 0.99, F1-score 0.94 and Matthew’s correlation coefficient (MCC) 0.92. The prediction of the irAE onset was more difficult with accuracy score 0.96, AUC value 0.93, F1-score 0.66 and MCC 0.64 but the model performance was still at a good level. Conclusion The current study suggests that ML based prediction models, using ePRO data as an input, can predict the presence and onset of irAEs with a high accuracy, indicating that ePRO follow-up with ML algorithms could facilitate the detection of irAEs in ICI-treated cancer patients. The results should be validated with a larger dataset. Trial registration Clinical Trials Register (NCT3928938), registration date the 26th of April, 2019

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Linguistic validation of the simplified Chinese version of the US National Cancer Institute’s patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE™)

BMC Cancer ◽

10.1186/s12885-020-07631-5 ◽

2020 ◽

Vol 20 (1) ◽

Author(s):

Cheng KKF ◽

S. A. Mitchell ◽

N. Chan ◽

E. Ang ◽

W. Tam ◽

...

Keyword(s):

Adverse Events ◽

Cancer Patients ◽

Patient Reported Outcomes ◽

A Priori ◽

Cognitive Interviews ◽

Simplified Chinese ◽

Patient Reported ◽

The Us ◽

The Common ◽

Response Choices

Abstract Background The aim of this study was to translate and linguistically validate the U.S. National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) into Simplified Chinese for use in Singapore. Methods All 124 items of the English source PRO-CTCAE item library were translated into Simplified Chinese using internationally established translation procedures. Two rounds of cognitive interviews were conducted with 96 cancer patients undergoing adjuvant treatment to determine if the translations adequately captured the PRO-CTCAE source concepts, and to evaluate comprehension, clarity and ease of judgement. Interview probes addressed the 78 PRO-CTCAE symptom terms (e.g. fatigue), as well as the attributes (e.g. severity), response choices, and phrasing of ‘at its worst’. Items that met the a priori threshold of ≥20% of participants with comprehension difficulties were considered for rephrasing and retesting. Items where < 20% of the sample experienced comprehension difficulties were also considered for rephrasing if better phrasing options were available. Results A majority of PRO-CTCAE-Simplified Chinese items were well comprehended by participants in Round 1. One item posed difficulties in ≥20% and was revised. Two items presented difficulties in < 20% but were revised as there were preferred alternative phrasings. Twenty-four items presented difficulties in < 10% of respondents. Of these, eleven items were revised to an alternative preferred phrasing, four items were revised to include synonyms. Revised items were tested in Round 2 and demonstrated satisfactory comprehension. Conclusions PRO-CTCAE-Simplified Chinese has been successfully developed and linguistically validated in a sample of cancer patients residing in Singapore.

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