Developing a fit-for-purpose composite symptom score as a symptom burden endpoint for clinical trials in patients with malignant pleural mesothelioma.

We developed a composite symptom score (CSS) representing disease-related symptom burden over time in patients with malignant pleural mesothelioma (MPM). Longitudinal data were collected from an open-label Phase IIB study in which 239 patients completed the validated MD Anderson Symptom Inventory for MPM (MDASI-MPM). A blinded, independent review committee of external patient-reported outcomes experts advised on MDASI-MPM symptoms to include in the CSS. Through iterative analyses of potential symptom-item combinations, 5 MPM symptoms (pain, fatigue, shortness of breath, muscle weakness, coughing) were selected. The CSS correlated strongly with the full MDASI-MPM symptom set (0.92-0.94) and the Lung Cancer Symptom Scale-Mesothelioma (0.79-0.87) at each co-administration of the scales. The CSS also had good sensitivity to worsening disease and global quality-of-life ratings. The MDASI-MPM CSS can be used as an outcome in MPM clinical trials, including in responder analyses and at the individual patient level. It is brief enough to administer frequently, including electronically, to better capture symptom trajectories during and after a trial and in clinical practice. As a single score, the CSS addresses multiplicity issues that can arise when several symptoms increase due to worsening disease. Our process can be adapted to produce a CSS for other advanced-cancer trials.

Patient-reported outcome measures in surgical patients with upper gastrointestinal cancers: A qualitative interview study.

BACKGROUND AND OBJECTIVES: Patients with pancreatic and gastroesophageal (PGE) cancers experience high symptom burden, but patient experience throughout multimodality treatment remains unclear. We aimed to delineate the experience and symptom burden of patients throughout their perioperative course. METHODS: Qualitative interviews were performed with 17 surgical patients with PGE cancer. Interview transcripts were analyzed and symptoms were ranked by frequency. An expert panel assessed the relevance of these symptom inventory items. RESULTS: Of the 17 patients included, 35% (n = 6) underwent gastrectomy, 30% (n = 5) underwent esophagectomy, and 35% (n = 6) underwent pancreatectomy; 76% (n = 13) received neoadjuvant systemic chemotherapy and/or chemoradiation. Overall, 32 symptoms were reported, and 19 were reported by over 20% of patients. An expert panel rated nine symptoms to be relevant or very relevant to PGE surgical patients. These symptoms (difficulty swallowing, heartburn/reflux, diarrhea, constipation, flushing/sweating, stomach feeling full, malaise, dizziness, or feeling cold) were added to the core MD Anderson Symptom Inventory (MDASI) if they were commonly reported or reached a threshold relevancy score. CONCLUSIONS: In this qualitative study, we developed a provisional symptom inventory for patients undergoing surgery for PGE cancer. This symptom inventory module of the MDASI for PGE surgical patients will be psychometrically tested for validity and reliability.

Longitudinal perioperative patient-reported outcomes in open compared with minimally invasive hysterectomy.

BACKGROUND: There are few prospective studies in the gynecologic surgical literature that compared patient-reported outcomes between open and minimally invasive hysterectomies within enhanced recovery after surgery pathways. OBJECTIVE: This study aimed to compare prospectively collected perioperative patient-reported symptom burden and interference measures in open compared with minimally invasive hysterectomy cohorts within enhanced recovery after surgery pathways. STUDY DESIGN: We compared patient-reported symptom burden and functional interference in 646 patients who underwent a hysterectomy (254 underwent open surgery and 392 underwent minimally invasive surgery) for benign and malignant indications under enhanced recovery after surgery protocols. Outcomes were prospectively measured using the validated MD Anderson Symptom Inventory, which was administered perioperatively up to 8 weeks after surgery. Cohorts were compared using Fisher exact and chi-squared tests, adjusted longitudinal generalized linear mixed modeling, and Kaplan Meier curves to model return to no or mild symptoms. RESULTS: The open cohort had significantly worse preoperative physical functional interference (P=.001). At the time of hospital discharge postoperatively, the open cohort reported significantly higher mean symptom severity scores and more moderate or severe scores for overall (P<.001) and abdominal pain (P<.001), fatigue (P=.001), lack of appetite (P<.001), bloating (P=.041), and constipation (P<.001) when compared with the minimally invasive cohort. The open cohort also had significantly higher interference in physical functioning (score 5.0 vs 2.7; P<.001) than the minimally invasive cohort at the time of discharge with no differences in affective interference between the 2 groups. In mixed modeling analysis of the first 7 postoperative days, both cohorts reported improved symptom burden and functional interference over time with generally slower recovery in the open cohort. From 1 to 8 postoperative weeks, the open cohort had worse mean scores for all evaluated symptoms and interference measures except for pain with urination, although scores indicated mild symptomatic burden and interference in both cohorts. The time to return to no or mild symptoms was significantly longer in the open cohort for overall pain (14 vs 4 days; P<.001), fatigue (8 vs 4 days; P<.001), disturbed sleep (2 vs 2 days; P<.001), and appetite (1.5 vs 1 days; P<.001) but was significantly longer in the minimally invasive cohort for abdominal pain (42 vs 28 days; P<.001) and bloating (42 vs 8 days; P<.001). The median time to return to no or mild functional interference was longer in the open than in the minimally invasive hysterectomy cohort for physical functioning (36 vs 32 days; P<.001) with no difference in compositive affective functioning (5 vs 5 days; P=.07) between the groups. CONCLUSION: Open hysterectomy was associated with increased symptom burden in the immediate postoperative period and longer time to return to no or mild symptom burden and interference with physical functioning. However, all patient-reported measures improved within days to weeks of both open and minimally invasive surgery and differences were not always clinically significant.

Inflammatory Breast Cancer: Understanding the Patient Experience.

BACKGROUND: Inflammatory breast cancer (IBC) is an aggressive, locally advanced cancer with a 5-year survival rate of approximately 40%. Although patients with IBC likely experience significant and variable symptom burden from diagnosis through survivorship, the description of the symptom burden in this population is limited. OBJECTIVES: The purpose of this study was to describe the experience of patients with IBC and define the content domain for a patient-reported outcome measure of IBC symptom burden. METHODS: Twenty patients with IBC described their experience in single qualitative interviews. Content analysis was used to define the symptom burden content domain. Relevance ratings by a panel of experts reduced the number of items for a preliminary patient-reported outcome symptom burden measure. RESULTS: The mean (SD) participant age was 52.8 (12.0) years; 50.0% had distant metastatic disease, and 85.0% were currently receiving treatment. Content analysis revealed 45 symptoms, with 20 symptoms reported by greater than or equal to 20% of participants. All participants described localized disease-related symptoms. Treatment-related symptoms varied among participants based on the modalities received. CONCLUSION: Patients with IBC experience symptom burden that is distinct from the symptom burden experienced by patients with non-IBC. IMPLICATIONS FOR PRACTICE: Differentiating the disease-related symptoms of IBC may assist clinicians in making timely and accurate diagnoses for IBC. A disease- and treatment-specific measure of the symptom burden of IBC should be incorporated in clinical practice to allow for regular assessment and evaluation of symptom burden and implementation of evidence-based interventions for symptom management.

Trans-pacific multicenter collaborative study of minimally invasive proximal versus total gastrectomy for proximal gastric and gastroesophageal junction cancers.

BACKGROUND: The current standard operation for proximal gastric and gastroesophageal junction (P/GEJ) cancers with limited esophageal extension is total gastrectomy (TG). TG is associated with impaired appetite and weight loss due to the loss of gastric functions such as production of ghrelin and with anemia due to intrinsic factor loss and vitamin B12 malabsorption. Theoretically, proximal gastrectomy (PG) can mitigate these problems by preserving gastric function. However, PG with direct esophagogastric reconstruction is associated with severe postoperative reflux, delayed gastric emptying, and poor quality of life (QoL). Minimally invasive PG (MIPG) with antireflux techniques has been increasingly performed by experts but is technically demanding owing to its complexity. Moreover, the actual advantages of MIPG over minimally invasive TG (MITG) with regards to postoperative QoL are unknown. Our overall objective of this study is to determine the short-term QoL benefits of MIPG. Our central hypotheses are that MIPG is safe and that patients have improved appetite after MIPG with effective antireflux techniques, which leads to an overall QoL improvement when compared with MITG. METHODS: Enrollment of a total of 60 patients in this prospective survey-collection study is expected. Procedures (MITG versus MIPG, antireflux techniques for MIPG [double-tract reconstruction versus the double-flap technique]) will be chosen based on surgeon and/or patient preference. Randomization is not considered feasible because patients often have strong preferences regarding MITG and MIPG. The primary outcome is appetite level (reported on a 0-10 scale) at 3 months after surgery. With an expected 30 patients per cohort (MITG versus MIPG), this study will have 80% power to detect a one-point difference in appetite level. Patient-reported outcomes will be longitudinally collected (including questions about appetite and reflux), and specific QoL items, body weight, body mass index and ghrelin, albumin, and hemoglobin levels will be compared. DISCUSSION: Surgeons from the US, Japan, and South Korea formed this collaboration with the agreement that the surgical approach to P/GEJ cancers is an internationally important but controversial topic that requires immediate action. At the completion of the proposed research, our expected outcome is the establishment of the benefit and safety of MIPG. TRIAL REGISTRATION: This trial was registered with Clinical Trials Reporting Program Registration under the registration number NCI-2022-00267 on January 11, 2022, as well as with ClinicalTrials.gov under the registration number NCT05205343 on January 11, 2022.

Measuring symptom burden in patients with cancer during a pandemic: the MD Anderson symptom inventory for COVID-19 (MDASI-COVID).

BACKGROUND: Symptom expression in SARS-CoV-2 infection (COVID-19) may affect patients already symptomatic with cancer. Patient-reported outcomes (PROs) can describe symptom burden during the acute and postacute stages of COVID-19 and support risk stratification for levels of care. At the start of the COVID-19 pandemic, our purpose was to rapidly develop, launch through an electronic patient portal, and provide initial validation for a PRO measure of COVID-19 symptom burden in patients with cancer. METHODS: We conducted a CDC/WHO web-based scan for COVID-19 symptoms and a relevance review of symptoms by an expert panel of clinicians treating cancer patients with COVID-19 to create a provisional MD Anderson Symptom Inventory for COVID-19 (MDASI-COVID). English-speaking adults with cancer who tested positive for COVID-19 participated in the psychometric testing phase. Patients completed longitudinal assessments of the MDASI-COVID and the EuroQOL 5 Dimensions 5 Levels (EQ-5D-5L) utility index and visual analog scale, which were presented through an electronic health record patient portal. To test the validity of the MDASI-COVID to distinguish between known groups of patients, we hypothesized that patients hospitalized, including having a hospitalization extended, for COVID-19 versus those not hospitalized would experience higher symptom burden. Correlation of mean symptom severity and interference scores with relevant EQ-5D-5L scores tested concurrent validity. The reliability of the MDASI-COVID was evaluated by calculating Cronbach alpha coefficients and test-retest reliability was evaluated by calculating Pearson correlation coefficients between the initial assessment and a second assessment no more than 14 days later. RESULTS: The web-based scan found 31 COVID-19-related symptoms; rankings of a 14-clinician expert panel reduced this list to 11 COVID-specific items to be added to the core MDASI. Time from literature scan start in March 2020 to instrument launch in May 2020 was 2 months. Psychometric analysis established the MDASI-COVID's reliability, known-group validity, and concurrent validity. CONCLUSIONS: We were able to rapidly develop and electronically launch a PRO measure of COVID-19 symptom burden in patients with cancer. Additional research is needed to confirm the content domain and predictive validity of the MDASI-COVID and define the symptom burden trajectory of COVID-19.

Symptom Burden in Patients with Malignant Bowel Obstruction Treated With or Without Surgery.

BACKGROUND: Gastrointestinal obstruction is the most common indication for palliative surgical consultation. We sought to assess patient-reported outcomes and survival after surgical and nonsurgical treatment of malignant bowel obstruction. STUDY DESIGN: This was a prospective observational study enrolling patients with advanced malignancy who underwent surgical consultation at a tertiary cancer center. Patient-reported outcomes were evaluated using a previously validated inventory, the MD Anderson Symptom Inventory-Gastrointestinal Obstruction (MDASI-GIO), administered at enrollment and 7 other time points for up to 90 days. RESULTS: We enrolled 125 patients, of whom 37 underwent surgery and 88 did not. Patients treated nonsurgically were more likely to have carcinomatosis on imaging (71% vs 49%, p = 0.02). Pain medicine, palliative care, and chaplaincy consultations occurred in 17%, 30%, and 15% of patients within the first month of enrollment. Higher mean symptom scores were noted by surgical patients, although the only single scores with effect sizes 0.5 or greater were symptom interference with general activity and work. The composite score for interference in work, activity, and walking had the largest effect size at -0.37, indicating greater interference in patients undergoing surgery. Patients selected for surgery had extended overall survival (median 15 vs 3 months, p < 0.01). Carcinomatosis, palliative care evaluation, and venting gastrostomy tube were associated with increased risk of death, and ability to receive subsequent chemotherapy and surgical management were positive prognostic indicators. CONCLUSIONS: In this first study evaluating patient-reported outcomes after treatment for malignant bowel obstruction, we found that selection for surgical treatment was associated with improved survival, but also more symptom interference in general activities and work. These results may be useful in palliative surgical decision-making and informing patients during consultation for malignant bowel obstruction.

Opioid-sparing anesthesia and patient-reported outcomes after open gynecologic surgery: a historical cohort study.

PURPOSE: Dexmedetomidine and ketamine may be administered intraoperatively as continuous infusions to provide opioid-sparing anesthesia. Recent evidence has yielded controversial results regarding the impact of opioid-free anesthesia on postoperative complications, and there is a gap in knowledge regarding patient-reported outcomes (PROs). This study aimed to determine the impact of opioid-sparing anesthesia and opioid-based anesthesia on PROs among gynecologic patients within an enhanced recovery after surgery (ERAS) program. METHODS: We formed a single-center historical cohort from patients enrolled in another study who underwent open gynecologic surgery on an ERAS program from November 2014 to December 2020 (n = 2,095). We identified two cohorts based on the type of balanced anesthesia administered: 1) opioid-sparing anesthesia defined as the continuous infusion of dexmedetomidine and ketamine (adjuvants) during surgery or 2) opioid-based anesthesia (no adjuvants). We measured the quality of postoperative recovery using the MD Anderson Symptom Inventory (MDASI), a 29-item validated tool that was administered preoperatively, daily while admitted, and weekly after discharge until week 6. The primary outcome was interference with walking. We matched both cohorts and used a multilevel linear mixed-effect model to evaluate the effect of opioid-sparing anesthesia on the primary outcome. RESULTS: In total, 498 patients were eligible (159 in the opioid-sparing anesthesia cohort and 339 in the opioid-based anesthesia cohort), of whom 149 matched pairs were included in the final analysis. Longitudinal assessment showed no significant or clinically important difference in interference with walking (P = 0.99), general activity (P = 0.99), or other PROs between cohorts. Median [interquartile range (IQR)] intraoperative opioid administration (expressed as morphine milligram equivalents [MME]) among matched patients in the opioid-sparing anesthesia cohort was 30 [25-55] mg vs 58 [8-70] mg in the opioid-based anesthesia cohort (P < 0.01). Patients in the opioid-sparing anesthesia cohort had a lower opioid consumption in the postanesthesia care unit than those in the opioid-based anesthesia cohort (MME, 3 [0-10] mg vs 5 [0-15] mg; P < 0.01), but there was no significant difference between cohorts in total postoperative opioid consumption (MME, 23 [0-94] mg vs 35 [13-95] mg P = 0.053). CONCLUSIONS: In this single-center historical cohort study, opioid-sparing anesthesia had no significant or clinically important effects on interference with walking or other PROs in patients undergoing gynecologic surgery compared with opioid-based anesthesia. Opioid-sparing anesthesia was associated with less short-term opioid consumption than opioid-based anesthesia.

RéSUMé: OBJECTIF: La dexmédétomidine et la kétamine peuvent être administrées en peropératoire sous forme de perfusions continues pour fournir une anesthésie avec épargne opioïde. Des données probantes récentes ont présenté des résultats controversés concernant l'impact d'une anesthésie sans opioïdes sur les complications postopératoires, et il existe une lacune dans les connaissances concernant les issues rapportées par les patients (IRP). Cette étude visait à déterminer l'impact d'une anesthésie avec épargne opioïde et d'une anesthésie à base d'opioïdes sur les IRP chez les patientes de chirurgie gynécologique dans le cadre d'un programme de Récupération rapide après la chirurgie (ERAS ­ Enhanced Recovery After Surgery). MéTHODE: Nous avons formé une cohorte historique monocentrique composée de patientes inscrites à une autre étude qui ont bénéficié d'une chirurgie gynécologique avec laparotomie dans le cadre d'un programme d'ERAS entre novembre 2014 et décembre 2020 (n = 2095). Nous avons identifié deux cohortes en fonction du type d'anesthésie équilibrée administrée : 1) anesthésie avec épargne opioïde, définie comme une perfusion continue de dexmédétomidine et de kétamine (adjuvants) pendant la chirurgie, ou 2) anesthésie à base d'opioïdes (sans adjuvants). Nous avons mesuré la qualité de la récupération postopératoire à l'aide de l'inventaire des symptômes MDASI, un outil validé comportant 29 éléments qui a été administré avant l'opération, quotidiennement pendant l'admission et chaque semaine après le congé jusqu'à la semaine 6. Le critère d'évaluation principal était l'interférence avec la marche. Nous avons apparié les deux cohortes et utilisé un modèle linéaire à effets mixtes à plusieurs niveaux pour évaluer l'effet de l'anesthésie avec épargne opioïde sur le critère d'évaluation principal. RéSULTATS: Au total, 498 patientes étaient éligibles (159 dans la cohorte d'anesthésie avec épargne opioïde et 339 dans la cohorte d'anesthésie à base d'opioïdes), dont 149 paires appariées ont été incluses dans l'analyse finale. L'évaluation longitudinale n'a révélé aucune différence significative ou cliniquement importante dans l'interférence avec la marche (P = 0,99), l'activité générale (P = 0,99), ou d'autres IRP entre les deux cohortes. L'administration médiane d'opioïdes peropératoires [écart interquartile (ÉIQ)] (exprimée en équivalents de morphine en milligrammes [EMM]) chez les patientes appariées de la cohorte d'anesthésie avec épargne opioïde était de 30 [25-55] mg vs 58 [8­70] mg dans la cohorte d'anesthésie à base d'opioïdes (P < 0,01). Les patientes de la cohorte d'anesthésie avec épargne opioïde avaient une consommation d'opioïdes plus faible en salle de réveil que celles de la cohorte d'anesthésie à base d'opioïdes (EMM, 3 [0-10] mg vs 5 [0­15] mg; P < 0,01), mais il n'y avait pas de différence significative entre les cohortes dans la consommation totale d'opioïdes postopératoires (EMM, 23 [0-94] mg vs 35 [13­95] mg; P = 0,053). CONCLUSION: Dans cette étude de cohorte historique monocentrique, l'anesthésie avec épargne opioïde n'a eu aucun effet significatif ou cliniquement important sur l'interférence avec la marche ou d'autres IRP chez les patientes bénéficiant d'une chirurgie gynécologique par rapport à l'anesthésie à base d'opioïdes. L'anesthésie avec épargne opioïde était associée à une consommation d'opioïdes moindre à court terme que l'anesthésie à base d'opioïdes.

Validation and Application of MD Anderson Symptom Inventory Module for Patients with Bladder Cancer in the Perioperative Setting.

Objectives: We developed and validated a disease-specific tool for perioperative patient-reported outcomes assessment for bladder cancer (BLC) patients undergoing radical cystectomy, The MD Anderson Symptom Inventory (the MDASI-PeriOp-BLC). Methods: Patients who underwent radical cystectomy were recruited. We used qualitative interviews and experts' input to generate disease/treatment-specific items of the MDASI-PeriOp-BLC module; conducted item reduction; examined the psychometric properties of the resultant items for reliability, validity, and clinical interpretability; and conducted cognitive debriefing interviews to assess the tool's performance. Results: A total of 150 BLC patients contributed to psychometric validation. We identified and defined eight BLC-specific module items (blood in urine, leaking urine, frequent urination, urinary urgency, burning with urination, constipation, changes in sexual function, and stomal problems). We included those 8 items in addition to 13 MDASI core symptoms and 6 interference items to form the MDASI-PeriOp-BLC module. Cronbach alphas were 0.89 and 0.90 for the 21 severity items and the 6 interference items, respectively. Test−retest reliability (intra-class correlation) was 0.92 for the 21 severity items. The MDASI-PeriOp-BLC module significantly differentiated the patients by performance status (p < 0.0001). Conclusions: The MDASI-PeriOp-BLC is a valid, reliable, and concise tool for monitoring symptom burden during perioperative care in BLC patients undergoing radical cystectomy.

Identification of Breast Cancer Survivors With High Symptom Burden.

BACKGROUND: While women diagnosed with breast cancer have increased survival when compared with other cancers, survivorship may include residual symptom burden from treatment and continuing endocrine therapies. OBJECTIVE: The objective of this study was to identify subgroups of breast cancer survivors experiencing similar symptom severity. METHODS: Participants were 498 women with breast cancer, not on active treatment. Symptom severity was self-reported using the MD Anderson Symptom Inventory. Target symptoms were included in a latent profile analysis. Factors related to subgroup membership and differences in quality of life (QOL) and functioning were explored using logistic regression. RESULTS: Mean age was 60.11 (SD, 11.32) years, 86.1% were white, and 79.1% were receiving endocrine therapy. Target symptoms included fatigue (reported at ≥5 by 22.8% of women), sleep disturbance (24.8%), and trouble remembering (17.2%). Two subgroups were identified: low symptom severity (77.0% of women) and high (23.0%). Older women (odds ratio [OR], 0.971; 95% confidence interval [CI], 0.952-0.989) and employed women (OR, 0.621; 95% CI, 0404-0.956) were less likely to be in the high subgroup; women with poorer performance status (OR, 1.653; 95% CI, 1.188-2.299) were more likely to be in the high subgroup. Women in the high subgroup reported lower QOL (P = .000) and greater interference with functioning (P = .000). CONCLUSIONS: Two subgroups of women with distinct symptom severity were identified. IMPLICATIONS FOR PRACTICE: Identification of women at risk for high symptoms during survivorship may allow clinicians to intensify their approach to symptom management, thereby mitigating poor outcomes and impairments in QOL.

Development and Validation of a Patient-reported Outcome Measure for Gastrointestinal Obstruction in the Setting of Advanced Malignancy.

OBJECTIVE: We sought to construct a valid and reliable patient-reported outcome measure for patients with advanced malignancy and GIO. BACKGROUND: Bowel obstruction is the most common indication for palliative surgical consultation in patients with advanced cancer; however, no validated patient-reported outcome measures exist for this population. METHODS: A total of 125 patients with GIO and 64 patients without GIO who underwent palliative surgical consultation completed the MDASI-GIO questionnaire and a single global quality-of-life question. Summary statistics were used to assess the symptom burden of GIO patients. Outcome measures were validity (construct and criterion) and reliability (internal and test-retest) for the MDASI-GIO. RESULTS: The majority of patients rated the severity of each of the 5 following GIO-specific symptoms as moderate to severe (rating of ≥5 on a 0 to 10 scale): "being unable to eat'' (72%), "being unable to have a bowel movement'' (65%), "abdominal discomfort'' (62%), "stomach feeling full'' (55%), and "abdominal cramping'' (54%). The MDASI-GIO subscale Cronbach coefficient alpha values were 0.80-0.91, and intraclass correlations were 0.72-0.84. Correlations between MDASI-GIO subscales and global quality of life were -0.39 to-0.49 ( P < 0.001 for all comparisons). GIO patients had significantly worse symptoms and higher interference than did non-GIO patients (all P < 0.05) with effect-size differences of ≥0.36, supporting known-group validity. CONCLUSIONS: The MDASI-GIO shows initial validity and reliability for assessing the severity of symptoms of patients with GIO and the interference of these symptoms in patients' daily functioning.

The Unique Symptom Burden of Patients Receiving CAR T-Cell Therapy.

OBJECTIVES: There is little research on the patient experience of symptom burden from CAR T-cell therapy, and no validated measure specific to the symptoms of CAR T-cell therapy currently exists. The purpose of this study was to identify symptoms experienced and to determine the content domain for a patient-reported outcome (PRO) measuring symptom burden for patients who had received standard of care CAR T-cell therapy for advanced B-cell lymphoid malignancies. DATA SOURCES: Semi-structured qualitative interviews were conducted with a sample of 21 patients who had received CAR T-cell therapy. Content analysis was used to define the symptom burden content domain. CONCLUSION: Sixty-two percent of patients were interviewed within 3 months of therapy; 81.0% experienced cytokine release syndrome and 28.6% experienced neurotoxicity. Content analysis found 31 symptoms related to disease and treatment. The most common disease-related symptom identified by patients was pain (43%). The most common symptoms identified by patients as related to CAR T-cell therapy included fatigue (tiredness) (62%), lack of appetite (29%), headache (29%), chills or feeling cold (24%), and feeling confused (24%). The qualitative analysis also confirmed that symptoms interfere with daily activities, work, walking, relationships with others, mood, and enjoyment of life. IMPLICATIONS FOR NURSING PRACTICE: Patients who receive standard CAR T-cell therapy experience numerous symptoms related to disease and CAR T-cell therapy, including symptoms related to the T-cell infusion. Symptoms may result in interference with daily activities, relationships, treatment adherence, and mood. Oncology nurses should be aware of and assess symptom related to CAR T-cell therapy.

Development of a patient-reported outcome tool for assessing symptom burden during perioperative care in liver surgery: The MDASI-PeriOp-Hep.

PURPOSE: Based on the MD Anderson Symptom Inventory (MDASI), we developed a Patient-reported outcomes tool for hepatectomy perioperative care (MDASI-PeriOp-Hep). METHODS: To establish the content validity, we generated PeriOp-Hep-specific candidate items from qualitative interviews of patients (n = 30), and removed items that lacked clinical relevance on the basis of input from panels of patients, caregivers, and clinicians. The psychometric properties of the MDASI-PeriOp-Hep were validated (n = 150). The cognitive debriefing and clinical interpretability were assessed to confirm the ease of comprehension, relevance, and acceptability of the tool. RESULTS: Five symptoms specific to hepatectomy (abdominal bloating, tightness, or fullness; abdominal cramping; muscle weakness, instability, or vertigo; constipation; and incisional tightness) were identified as module items to form the MDASI-PeriOp-Hep. The Cronbach αs for symptoms and for interference were 0.898 and 0.861, respectively. The test-retest reliability was 0.887 for all 18 symptom severity items. Compared to other commonly used tools, correlation of MDASI-PeriOp-Hep scores to performance status (all, P < 0.001) and to the phase of perioperative care confirmed known-group validity. Convergent validity was excellent against other standard Patient-reported outcomes tools. Cognitive debriefing demonstrated that the MDASI-PeriOp-Hep was an easy to use and understandable tool. CONCLUSIONS: For integrating patient-reported outcomes in perioperative patient care, a procedure-specific tool is desirable. The MDASI-PeriOp-Hep is a valid, reliable, concise tool for measuring symptom severity and functional interference in patients undergoing liver surgery.

Psychometric validity and reliability of the Danish version of the MD Anderson Symptom Inventory Brain Tumor Module.

BACKGROUND: The complexity of disease- and treatment-related symptoms causes profound distress and deterioration of health-related quality of life among patients with brain tumors. Currently, there is no Danish validated disease-specific instrument that focuses solely on measures of both neurologic and cancer-related symptoms of patients with brain tumors. The MD Anderson Symptom Inventory Brain Tumor Module (MDASI-BT) is a validated patient self-report questionnaire that measures symptom prevalence, intensity, and interference with daily life. The aim of the present study was to determine the psychometric validity of the Danish translation of the MDASI-BT, and to test its utility in 3 cohorts of Danish patients across the spectrum of the brain cancer disease and treatment trajectory. METHODS: A linguistic validation process was conducted. Danish patients with malignant primary brain tumors were included to establish the psychometric validity and reliability of the Danish MDASI-BT. Cognitive debriefing interviews were conducted to support the psychometric properties. RESULTS: A total of 120 patients participated in this study. Coefficient αs for the symptom and interference subscales indicate a high level of reliability across all items. Corresponding symptom and interference or functional items and subscales in the MDASI-BT and European Organisation for Research and Treatment of Cancer Brain Tumor Module BN20 were significantly correlated. Cognitive debriefing provided evidence for content validity and questionnaire utility as participants were comfortable answering the questions and had no problem with the understandability or number of questions asked. CONCLUSION: The MDASI-BT is a simple, concise symptom assessment tool useful for assessing the symptom severity and interference of Danish-speaking patients with brain cancer.

Preferences of Individuals With Cancer for Patient-Reported Outcome Measures.

PURPOSE: Symptom monitoring and management using patient-reported outcome (PRO) measures improves outcomes for individuals with cancer. The purpose of the current study was to provide a qualitative assessment of preferences of individuals with cancer for PRO measures. PARTICIPANTS & SETTING: 15 patients receiving systemic therapy at the University of Texas MD Anderson Cancer Center. METHODOLOGIC APPROACH: Participants completed three PRO measures. Qualitative interviews were conducted, and content analysis was used to identify relevant themes. FINDINGS: Identified themes were the importance of communicating various aspects of the disease and treatment experience to the oncology team, the importance of systematic PRO assessments, congruence among PRO questionnaires and questions clinicians ask at clinic visits, concerns about the length of PRO questionnaires, the importance of the response options available in PRO questionnaires, and willingness to complete PRO measures frequently. IMPLICATIONS FOR NURSING: Oncology nurses are critical facilitators of the systematic use of PRO measures across the cancer care continuum.

Using the MDASI-Adolescent for Early Symptom Identification and Mitigation of Symptom Impact on Daily Living in Adolescent and Young Adult Stem Cell Transplant Patients.

Hematopoietic stem cell transplantation (HSCT) requires an intensive pre- and post-procedure course that leads to symptoms including fatigue, nausea/vomiting, and pain, all of which interfere significantly with activities of daily living. These symptoms place a substantial burden on patients during the time period surrounding transplant as well as during long-term recovery. The MD Anderson Symptom Inventory (MDASI) is a symptom-reporting survey that has been successfully used in adult patients with cancer and may have utility in the adolescent and young adult (AYA) population. At the Children's Cancer Hospital at MD Anderson Cancer Center, we adopted a modified version of the MDASI, the MDASI-adolescent (MDASI-Adol), as a standard of care for clinical practice in assessing the symptom burden of patients in the peri-transplant period. We then conducted a retrospective chart review to describe the clinical utility of implementing this symptom-screening tool in AYA patients admitted to our pediatric stem cell transplant service. Here, we report our findings on the symptom burden experienced by pediatric and AYA patients undergoing stem cell transplantation as reported on the MDASI-Adol. Our study confirmed that the MDASI-Adol was able to identify a high symptom burden related to HSCT in the AYA population and that it can be used to guide symptom-specific interventions prior to transplant and during recovery. Implementing a standard symptom-screening survey proved informative to our clinical practice and could mitigate treatment complications and alleviate symptom burden.

Symptom burden and its functional impact in patients with "symptomatic" relapsed or refractory multiple myeloma.

PURPOSE: Relapsed or refractory multiple myeloma (RRMM) is labeled "symptomatic" based on laboratory values, but not relevant to quantitative measure of patient's perspectives. This study aimed to describe symptom burden, health status, and quality of life in RRMM patients. METHODS: The cross-sectional study included 184 MM patients (141 RRMM cases and 43 MM patients on follow-up without diagnosis/treatment of RRMM disease as controls), while 64 RRMM patients also provided longitudinal patient-reported outcomes (PROs) data. Symptomatic status was based on clinical measures of disease activity. PROs included the MD Anderson Symptom Inventory multiple myeloma module (MDASI-MM), single-item quality of life (SIQOL), and EuroQol-5D (EQ-5D). Wilcoxon rank test and effect size were used for comparisons. Regression models were used to describe symptom trajectory and to identify predictors of high symptom burden during 3 months of RRMM therapy. RESULTS: Most patients were clinically identified as symptomatic (93%). RRMM patients tended to report more severe symptoms, with significantly lower QOL scores and more severe fatigue, poor appetite, and lower enjoyment of life compared with controls (all p < 0.05). In RRMM patients, lower hemoglobin and higher B-2 microglobulin levels significantly correlated with higher burdens of fatigue, pain, and muscle weakness and also with lower QOL and EQ-5D scores (all p < 0.05). During RRMM therapy, being female, with any comorbidity, ≥ 65 years old, and ≥ 5 years MM history, contributed to high symptoms burden and poor QOL status (each p < 0.05). CONCLUSIONS: MDASI-MM modules were sensitive to detect the RRMM-related symptoms burden, which correlated with objective clinical measures. RRMM patients reported a more compromised QOL.

ONS Guidelines™ for Cancer Treatment-Related Skin Toxicity.

BACKGROUND: Management of cancer treatment-related skin toxicities can minimize treatment disruptions and improve patient well-being. OBJECTIVES: This guideline aims to support patients and clinicians in decisions regarding management of cancer treatment-related skin toxicities. METHODS: A panel developed a guideline for management of cancer treatment-related skin toxicities using GRADE (Grading of Recommendations, Assessment, Development, and Evaluation) for certainty of evidence and the National Academies of Sciences, Engineering, and Medicine criteria for trustworthy guidelines. The Cochrane risk-of-bias tool assessed risk of bias. A quantitative or narrative synthesis of the evidence was completed. RESULTS: The panel issued seven conditional recommendations for epidermal growth factor receptor inhibitor rash, hand-foot skin reaction, hand-foot syndrome, and chemotherapy-induced alopecia. The panel suggested strategies for prevention and treatment for all toxicities except hand-foot syndrome, which only has a prevention recommendation. IMPLICATIONS FOR NURSING: Cancer treatment-related skin toxicities can significantly affect quality of life. Incorporation of these interventions into clinical care can improve patient outcomes. SUPPLEMENTARY MATERIAL CAN BE FOUND AT&NBSP;HTTPS: //onf.ons.org/supplementary-material-ons-guidelines-cancer-treatment-related-skin-toxicity.

What Do Patients With Non-Small-Cell Lung Cancer Experience? Content Domain for the MD Anderson Symptom Inventory for Lung Cancer.

PURPOSE: Symptom monitoring has demonstrated improved outcomes in patients with cancer, including quality of life, resource utilization, ability to continue treatment, and survival. The use of disease-specific patient-reported outcome (PRO) measures facilitates symptom monitoring. While the MD Anderson Symptom Inventory-Lung Cancer (MDASI-LC), a PRO measure of symptom burden in lung cancer, is psychometrically validated for use in patients with NSCLC, its content validity has not been verified through direct patient input. Our purpose is to describe the symptom experience of patients with NSCLC and to confirm that the MDASI-LC contains the key symptoms specific to NSCLC from the patient perspective. METHODS: Patients with NSCLC described their symptom experience in single qualitative interviews. Content analysis was used to define the content domain for a PRO measure of NSCLC symptom burden. RESULTS: Participants (N = 40) had a mean age of 66.1 years (standard deviation, 10.9 years); 60.0% were male, 77.5% were White, and 56.4% had stage IV disease. Thirty-two symptoms were described, with 6 reported by ≥ 20% of participants. Symptom variations were noted by treatment modality but not by stage of disease. Patients with NSCLC commonly reported shortness of breath, cough, distress, fatigue, pain, and constipation. In patients receiving chemotherapy, treatment-related symptoms, including neuropathy and sore mouth, were commonly noted. The presence of these symptoms resulted in interference with daily activities, relationships, life plans, treatment adherence, and mood. CONCLUSION: The symptoms included in the MDASI-LC are important components of the content domain of an NSCLC symptom burden measure. The presence of these symptoms affect daily life and, therefore, is of clinical consequence.

In Search of the Optimal Outcome Measure for Patients with Advanced Cancer and Gastrointestinal Obstruction: A Qualitative Research Study.

BACKGROUND: Gastrointestinal obstruction (GIO) is the most common indication for palliative surgical consultation in patients with advanced cancer. The purpose of this study is to delineate the symptom burden and experience of these patients. PATIENTS AND METHODS: Twenty patients with advanced cancer and GIO described symptoms at time of surgical consultation. We analyzed the content of interview transcripts and ranked symptoms by frequency and according to an assessment of relevance conducted by an expert panel (surgeons, palliative care physicians, nurses, and patients/caregivers). RESULTS: Among the 20 study patients, malignancy types included colorectal (n = 9), gastric (n = 4), urothelial/renal (n = 3), and other (n = 4), whereas sites of obstruction were the small bowel (n = 11), gastric outlet (n = 3), and large bowel (n = 6). Thirteen patients (65%) had received chemotherapy within 6 weeks. Imaging evidence of a primary/recurrent tumor was documented in 13 patients (65%), carcinomatosis in 11 (55%), and ascites in 16 (80%). Thirty patient symptoms were identified on qualitative interviewing. Seven GIO-specific items were identified as relevant by the expert panel and will be added to the core symptom assessment inventory for further testing. CONCLUSIONS: We identified symptoms of importance that can be used to assess outcome after treatment of patients with advanced cancer and GIO. Testing for validity and reliability will be required before formal survey development.