MD Anderson Symptom Inventory Research Articles

The Effect of Temperament on the Association Between Pre-treatment Anxiety and Chemotherapy-Related Symptoms in Patients With Breast Cancer.

Pre-treatment anxiety (PA) before chemotherapy increases complaints of chemotherapy-related symptoms (CRS). The results on the association have been inconsistent, and the effect of temperament remains unclear. We aimed to determine whether PA is a risk factor for CRS and the effect of differing temperaments on CRS. This prospective study comprised 176 breast cancer patients awaiting adjuvant chemotherapy post-surgery. We assessed CRS, PA, and temperament using the MD Anderson Symptom Inventory (MDASI), the Hospital Anxiety and Depression Scale, and the short form of the Temperament and Character Inventory-Revised, respectively. The MDASI was re-administered three weeks after the first chemo-cycle. PA showed weak positive correlation with several CRS after the first cycle; no CRS was significantly associated with PA when pre-treatment depressive symptoms and baseline CRS were adjusted in multiple regression analysis. Moderation model analysis indicated that the PA effect on several CRS, including pain, insomnia, anorexia, dry mouth, and vomiting, was moderated by harm avoidance (HA) but not by other temperament dimensions. In particular, PA was positively associated with CRS in patients with low HA. The results in patients with low HA indicate that more attention to PA in patients with confident and optimistic temperaments is necessary.

Quality of life and symptom distress after cytoreductive surgery and hyperthermic intraperitoneal chemotherapy.

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS/ HIPEC) for peritoneal surface malignancy can effectively control the disease, however it is also associated with adverse effects which may affect quality of life (QoL). To investigate early perioperative QoL after CRS/HIPEC, which has not been discussed in Taiwan. This single institution, observational cohort study enrolled patients who received CRS/HIPEC. We assessed QoL using the Taiwanese version of the MD Anderson Symptom Inventory (MDASI-T) and European Organization Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30). Participants completed the questionnaires before CRS/HIPEC (S1), at the first outpatient follow-up (S2), and 3 mo after CRS/HIPEC (S3). Fifty-eight patients were analyzed. There was no significant perioperative difference in global health status. Significant changes in physical and role functioning scores decreased at S2, and fatigue and pain scores increased at S2 but returned to baseline at S3. Multiple regression analysis showed that age and performance status were significantly correlated with QoL. In the MDASI-T questionnaire, distress/feeling upset and lack of appetite had the highest scores at S1, compared to fatigue and distress/feeling upset at S2, and fatigue and lack of appetite at S3. The leading interference items were working at S1 and S2 and activity at S3. MDASI-T scores were significantly negatively correlated with the EORTC QLQ-C30 results. QoL and symptom severity improved or returned to baseline in most categories within 3 mo after CRS/HIPEC. Our findings can help with preoperative consultation and perioperative care.

A Phase 3 Double-Blind, Randomized, Placebo Controlled Study to Evaluate the Efficacy and Safety of AB-205 Plus Standard of Care (SOC) Versus Placebo Plus Standard of Care in Adults with Lymphoma Undergoing High-Dose Therapy and Autologous Hematopoietic Cell Transplantation (E-CELERATE) (NCT05181540) - Trials in Progress

Myeloablative conditioning or high-dose therapy followed by autologous hematopoietic cell transplantation (HDT-AHCT) is a standard of care (SOC) and potentially curative consolidation therapy for eligible patients diagnosed with aggressive lymphoma. Although effective in chemosensitive patients, HDT-AHCT is associated with severe regimen-related toxicities (SRRTs) that affect quality of life and may increase mortality risk (Olivieri et al., BBMT 2018). SRRTs occur due to the off-target cytotoxicity of HDT that involves damage to the microvasculature and the vascular stem cell niches of multiple organs. SRRTs predominantly affect organs with high cell turnover causing severe complications such as diffuse gastrointestinal (GI) mucositis (oral/GI SRRT) and delayed hematopoietic recovery. Rates and severity of toxicities increase with age, relevant to the demographics of the aging lymphoma population. Importantly, patients identify oral/GI SRRT as one of the most severe adverse effects experienced with HDT-AHCT (Stiff et al., BMT 2001). Notwithstanding, there are limited treatment strategies aimed at preventing SRRTs. AB-205 is an experimental, engineered cell therapy that consists of allogeneic, human umbilical vein endothelial cells transduced with the pro-survival E4ORF1+ gene (E-CEL® cells). The proposed mechanism of action is paracrine in nature consisting of cell expression of reparative angiocrine factors which are thought to accelerate the repair injuries from off-target cytotoxicity of myeloablative conditioning. In a previously presented Phase 1/2 study [NCT03925935] in HCT-eligible patients with lymphoma, AB-205 was well tolerated and resulted in a 9% incidence of early oral/GI SRRT [defined as Grade ≥3 mucositis (M), nausea (N), vomiting (V) or diarrhea (D) in systemic lymphoma subjects conditioned with BEAM and BEAM-alternates (Phase 1/2 data is locked and analysis is in progress). This oral/GI SRRT incidence compared highly favorably to an incidence rate of 41% resulting from a contemporary, retrospective observational study conducted at two phase 1/2 sites (done concurrently during the conduct of the phase 1/2 study). Accordingly, a phase 3, randomized, double-blind, placebo-controlled multi-center study (E-CELERATE) has been initiated to further investigate the efficacy and safety of AB-205 in reducing (preventing) severe toxicities and complications related to off-target cytotoxicity of myeloablative HDT. Approximately 140 patients will be enrolled across 25 sites in the United States. Key inclusion criteria: Age ≥ 40; diagnosis of Hodgkin or non-Hodgkin lymphoma who are candidates for HDT-AHCT with one of the following myeloablative conditioning regimens: carmustine, etoposide, cytarabine, melphalan (BEAM); bendamustine, etoposide, cytarabine, melphalan (BeEAM); achieved complete response (CR) or partial response (PR) prior to planned HDT; ECOG ≤ 2; serum bilirubin ≤ 2 mg/dL; AST, ALT, and alkaline phosphatase < 3 × ULN. Key exclusion criteria: Prior HCT; primary CNS lymphoma; systemic lymphoma with secondary CNS involvement at time of relapse prior to planned HDT-AHCT; active malignancy other than the one for which the subject is undergoing HDT-AHCT; subjects with a known history of HIV. Endpoints: The primary endpoint is complete response defined as the absence of oral/GI SRRT (NCI CTCAE Grade ≥ 3 M, N, V, or D from the time of HDT through Day +21 post-HCT). Secondary endpoints include the duration of oral/GI SRRT; patient-reported symptom burden per MD Anderson Symptom Inventory; duration of febrile neutropenia; time to neutrophil engraftment; incidence of Grade ≥ 3 non-hematologic treatment emergent AEs; absence of SRRT; and survival endpoints: non-relapse mortality, progression free survival and overall survival. Eligible patients will be randomized 1:1 to receive SOC supportive care prophylaxis + AB-205 or placebo intravenously (IV) given on Day 0 within 4 hours of AHCT. 20×106 cells/kg AB-205 IV or an analogous volume of placebo IV will be administered. Randomization will be stratified by lymphoma type (HL/NHL), hematopoietic cell transplantation-comorbidity index, disease status prior to HDT (CR/PR). Daily assessments of oral/GI SRRT will occur from start of HDT to Day +21 post AHCT (Figure 1). Current status: Active recruitment and enrollment ongoing [NCT05181540]. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Is Disease Response a Patient-Centered Clinical Trial Endpoint in Acute Myeloid Leukemia: Differences in Symptom Burden and Physical Function By Response Status in the Beat-AML Master Trial

Objective: To inform regulatory decision making about trial design and drug approval, we examined whether disease response status is a patient-centered endpoint in therapeutic trials for acute myeloid leukemia (AML). Specifically, we estimated the association of response status with patient-reported symptoms and physical function in the Beat-AML Master Trial. Methods: The Beat-AML Master Trial (NCT03013998) is composed of a genomic screening protocol and multiple sub-studies of biomarker-based treatments for sub-types of acute myeloid leukemia. The patient-reported outcome (PRO) assessment occurred at baseline and at specified study visits about once per cycle depending on treatment phase. The PRO assessment included the MD Anderson Symptom Inventory (MDASI) AML/MDS symptom scale (17 items), additional symptom items from the MDASI library relevant to Beat-AML therapies (10 items), and the PROMIS® Physical Function short form (6 items). The two symptom scale scores range from 0-10 where higher scores indicate greater symptom burden; the physical function scale score ranges from 0-100 where higher scores indicate better physical function. Disease response was assessed according to 2017 ELN AML Recommendations, including: complete remission (CR), complete remission without minimal residual disease (CRMRD-), complete remission with hematologic improvement (CRh), complete remission with incomplete blood count recovery (CRi), morphological leukemia free state (MLFS), partial remission (PR), stable disease, progressive disease, recurrence/relapse, and treatment failure. For this analysis, response status was identified for each PRO assessment timepoint. Linear mixed effects models estimated the differences in PRO scores between each response status and CR. The analytic sample was composed of individuals who completed the baseline PRO assessment and at least one PRO assessment post baseline. The minimally important difference (MID) for the PROMIS Physical Function scale is 4 points (Yost, J Clin Epi 2012). The symptom scales do not have established MID, so coefficients were compared to a small effect size (0.20) per Cohen's d. Results: The analytic sample included 240 patients from 11 Beat-AML sub-studies; the median age was 73 years (range: 42-90) and 42.5% were female. Median follow-up time with PRO assessments was 18.4 months. The survey response rate was 80.7%. The mean (standard deviation) PRO scale scores at baseline were: 2.11 (1.67) AML/MDS symptom scale, 1.54(1.54) additional symptoms, and 36.65(9.62) Physical Function. The proportion of patients achieving each response at any point during protocol treatment was 32.1% CR, 7.5% CRMRD-, 6.7% CRh, 23.3% CRi, 19.6% MLFS, 5.8% PR, 73.3% stable disease, 11.7% progressive disease, 20.0% recurrence/relapse, and 7.5% treatment failure, for an average of 2.4 responses per patient. After controlling for age, gender, treatment (sub-study), time since baseline, and adjusting for drop-out missingness, we found that, compared to CR, symptom burden was greater for MLFS and stable disease (coefficient range 0.33 to 0.66) (see Table 1). Symptom burden per the AML/MDS scale only was also greater for recurrence/relapse (coef. 0.49). Physical function was worse (per MID) for MLFS, stable disease, and progressive disease (coefficient range: -4.42 to -4.76). Discussion: PRO data from 11 sub-studies of the Beat AML Master Trial indicate key differences and similarities between disease response statuses in terms of symptom burden and physical function. MLFS was the only type of response that differed from CR with respect to symptom burden and physical function. Stable disease and recurrence/relapse were associated with greater symptom burden than CR, but progressive disease was not, however it was associated with worse physical function. Findings regarding treatment failure may be limited by small sample and wide range of health within that status. Sensitivity analyses will include removing rare symptoms from the symptom scales, which may increase model coefficients. Subsequent analysis will examine the association of the patient's best response status with long term physical function. Conclusion: Further research is warranted to establish the response statuses of CRMRD-, CRh, CRi, and partial remission as clinical trial endpoints that are valuable to patients with respect to health-related quality of life. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

Patient-Reported Financial Toxicity in a Population-Based Cohort of Oropharynx Cancer Survivors

Patients with oropharyngeal squamous cell carcinoma (OPSCC) are at high risk for financial toxicity (FT), but the nature, extent, and predictors of FT experienced after primary radiation therapy (RT) or surgery are poorly understood. We used a population-based sample of patients from the Texas Cancer Registry with stage I to III OPSCC diagnosed from 2006 to 2016 and treated with primary RT or surgery. Of 1,668 eligible patients, 1,600 were sampled, 400 responded, and 396 confirmed OPSCC. Measures included the MD Anderson Symptom Inventory Head and Neck, Neck Dissection Impairment Index, and a financial toxicity instrument adapted from the Individualized Cancer Care (iCanCare) study. Multivariable logistic regression evaluated associations of exposures with outcomes. Of 396 analyzable respondents, 269 (68%) received primary RT and 127 (32%) surgery. The median time from diagnosis to survey was 7 years. Due to OPSCC, 54% of patients experienced material sacrifice (including 28% who reduced food spending and 6% who lost their housing), 45% worried about financial problems, and 29% experienced long-term FT. Independent factors associated with more long-term FT included female sex (odds ratio [OR], 1.72; 95% confidence interval [CI], 1.23-2.40), Black non-Hispanic race (OR, 2.98; 95% CI, 1.26-7.09), unmarried status (OR, 1.50; 95% CI, 1.11-2.03), feeding tube use (OR, 3.98; 95% CI, 2.29-6.90), and worst versus best quartile on the MD Anderson Symptom Inventory Head and Neck (OR, 1.89; 95% CI, 1.23-2.90) and Neck Dissection Impairment Index (OR, 5.62; 95% CI, 3.79-8.34). Factors associated with less long-term FT included age >57 years (OR, 0.54; 95% CI, 0.41-0.71; P < .001) and household income ≥$80,000 (OR, 0.60; 95% CI, 0.44-0.82; P=.001). Primary RT versus surgery was not associated with long-term FT (OR, 0.92; 95% CI, 0.68-1.24). Oropharynx cancer survivors experience high rates of material sacrifice and long-term FT, and we identified important risk factors. Chronic symptom burden was associated with significantly worse long-term financial status, supporting the hypothesis that toxicity mitigation strategies may reduce long-term FT.

Evaluating Heterogeneity of Hippocampal Avoidant Whole Brain Radiotherapy (HA-WBRT) Treatment Effect on Neurocognitive Function (NCF): Secondary Analysis of NRG-CC001

<h3>Purpose/Objective(s)</h3> NRG-CC001, a trial evaluating the neuroprotective effect of HA-WBRT versus standard WBRT in patients with brain metastases (BM), demonstrated a significantly lower risk of NCF decline. Given the heterogeneous BM patient population, we sought to systematically identify subgroups of patients through secondary analysis of trial data that could derive differential benefit from HA. <h3>Materials/Methods</h3> We performed a post hoc analysis of NRG-CC001, a phase III clinical trial in which 518 patients with BM were randomly assigned to WBRT plus memantine or HA-WBRT plus memantine. In this secondary analysis, cumulative incidence function (CIF) estimated NCF failure between arms and subgroups was tested using Gray's test. Covariate and subgroup association with differential treatment response was calculated using Cox proportional hazards modeling; these factors were then tested for interaction with treatment arm. <h3>Results</h3> Age (>61), education (<high school) irrespective of treatment arm were predictive of higher risk of NCF failure (p=0.005 and p=0.007, respectively). Patients living <4 months derived no benefit from HA-WBRT (Gray's test p=0.793), but for those living >=4 months, there was a significant benefit favoring HA-WBRT (p=0.03). We found evidence of heterogeneity of treatment effect based on primary tumor histology (interaction test p=0.01): primary lung histology patients (HR 0.58, 95% CI: 0.43-0.77, p=0.0007) compared to those with non-lung histology primary tumors (HR 1.15, 95% CI: 0.78-1.71, p=0.48). Baseline MD Anderson Symptom Inventory for brain tumor (MDASI-BT) cognitive factor scores were also found to be highly associated with treatment response with significance on test for interaction (p=0.03); those with MDASI-BT baseline scores in quartiles 1-3 had significantly greater differential treatment response (HR=0.64, 95% CI: 0.48-0.85, p=0.002) compared to those with the highest MDASI-BT baseline scores (HR=1.24, 95% CI: 0.76-2.04, p=0.39). There was no significant heterogeneity of treatment effect based on age, education level, and baseline KPS. <h3>Conclusion</h3> This post-hoc subgroup analysis of NRG-CC001 evaluating heterogeneity of treatment effect confirmed that the neurocognitive protective benefit of HA-WBRT was most substantial for patients living > 4 months; for those surviving <4 months, statistically significant benefit was not identified, possibly because cognitive decline post-WBRT requires a window of time to manifest. We also found that treatment response was significantly associated with several patient and tumor characteristics. Patients with lung histology as well as those with lower baseline MDASI-BT cognitive factor scores, denoting less severe cognitive impairment at enrollment, had significantly greater benefit from HA-WBRT. These data may better help clinicians decide which subgroups of patients benefit most from HA-WBRT.

Patient-Reported Financial Toxicity in a Population-Based Cohort of Oropharynx Cancer Survivors after Primary Radiotherapy or Surgery

<h3>Purpose/Objective(s)</h3> Patients with oropharynx cancer are at risk for financial toxicity due to the intensive treatment and impact on critical normal functions such as eating and speaking. The nature, extent, and predictors of financial toxicity experienced after primary radiotherapy (RT) or surgery are not well-described in this population. Since the treatment strategy for oropharynx cancer is likely sensitive to patient preferences, the effects on financial toxicity may inform decision-making and facilitate interventions. <h3>Materials/Methods</h3> We identified a population-based sample of oropharynx cancer patients from the Texas Cancer Registry aged ≥18, diagnosed 2006-2016, stage I-III, and treated with primary RT or primary surgery +/- post-operative RT (PORT). Out of 1,668 eligible patients, 1,600 were mailed an invitation, survey, and $10 gift card in 2020-21. The survey included demographic and treatment questions, the MD Anderson Symptom Inventory Head and Neck (MDASI-HN), Neck Dissection Impairment Index (NDII), Effectiveness of Auditory Rehabilitation (EAR) scale, and an 8-question financial toxicity instrument adapted from the iCanCare study. Multivariable (MVA) logistic regression identified predictors of self-reported long-term financial decline attributable to cancer and treatment with p<0.05 considered significant. <h3>Results</h3> In total, 400 patients responded (25% response rate), of whom 271 (68%) received primary RT and 129 (32%) primary surgery. Of primary surgery patients, 105 (83%) received PORT while 22 (17%) did not. Median time from diagnosis to survey was 7 years. Overall, due to oropharynx cancer, 45% used personal savings, 19% could not make bill payments, 28% cut down on food spending, 2% had utilities turned off, 6% could no longer afford their housing, and 54% experienced some form of financial toxicity. Patients who received primary surgery without PORT used less personal savings (p=0.04) with less short-term financial toxicity overall (p=0.04). At the time of survey, 45% of patients worried about financial problems because of their cancer and treatment. On MVA, factors associated with worse long-term financial status included younger age (≤57 years), primary RT (only in >57 years), female sex, Black non-Hispanic race, unmarried status, lower income, tonsil subsite, more recent diagnosis, and worse scores on the MDASI-HN, NDII, and EAR. <h3>Conclusion</h3> In this population-based cohort, oropharynx cancer survivors reported high rates of short- and long-term financial toxicity, with nearly half worrying about financial problems due to their cancer at a median 7 years after diagnosis. Higher chronic symptom burden was associated with worse long-term financial status while the effect of primary RT vs surgery was significantly modified by age. The subset of primary surgery without PORT reported less short-term financial toxicity. Identifying patients with risk factors for financial toxicity presented here may allow for appropriate intervention and counseling.

Symptom burden, psychological distress, and symptom management status in hospitalized patients with advanced cancer: a multicenter study in China

The management of physical symptoms and psychological distress of cancer patients is an important component of cancer care. The purpose of this study was to evaluate the symptom burden, psychological distress, and management status of hospitalized patients with advanced cancer in China and explore the potential influencing factors of undertreatment and non-treatment of symptoms. A total of 2930 hospitalized patients with advanced cancer (top six types of cancer in China) were recruited from 10 centers all over China. Patient-reported MD Anderson Symptom Inventory, Hospital Anxiety and Depression Scale (HADS), and Patient Health Questionnaire-9 (PHQ-9) scales and symptom management-related information were collected and linked with the patient's clinical data. The proportion of patients reporting moderate-to-severe (MS) symptoms and whether they were currently well managed were examined. Multivariable logisticregression models were applied to explore the factors correlated to undertreatment and non-treatment of symptoms. About 27% of patients reported over three MS symptoms, 16% reported over five, and 9% reported over seven. Regarding psychological distress, the prevalence of HADS-anxiety was 29% and that of PHQ-9 depression was 11%. Sixty-one percent of patients have at least one MS symptom without any treatment. Sex [odds ratio (OR)= 2.238, 95% confidence interval (95% CI) 1.502-3.336], Eastern Cooperative Oncology Group (ECOG; OR= 0.404, 95% CI 0.241-0.676), and whether currently undergoing anticancer treatment (OR= 0.667, 95% CI 0.503-0.886) are the main factors correlated with the undertreatment of symptoms. Age (OR= 1.972, 95% CI 1.263-3.336), sex (OR= 0.626, 95% CI 0.414-0.948), ECOG (OR= 0.266, 95% CI 0.175-0.403), whether currently undergoing anticancer treatment (OR= 0.356, 95% CI 0.249-0.509), and comorbidity (OR= 0.713, 95% CI 0.526-0.966) are the main factors correlated with the non-treatment of symptoms. This study shows that hospitalized patients with advanced cancer had a variety of physical and psychological symptoms but lacked adequate management and suggests that a complete symptom screening and management system is needed to deal with this complex problem.

Optimized decision support for selection of transoral robotic surgery or (chemo)radiation therapy based on posttreatment swallowing toxicity.

A primary goal in transoral robotic surgery (TORS) for oropharyngeal squamous cell cancer (OPSCC) survivors is to optimize swallowing function. However, the uncertainty in the outcomes of TORS including postoperative residual positive margin (PM) and extranodal extension (ENE), may necessitate adjuvant therapy, which may cause significant swallowing toxicity to survivors. A secondary analysis was performed on a prospective registry data with low- to intermediate-risk human papillomavirus-related OPSCC possibly resectable by TORS. Decision trees were developed to model the uncertainties in TORS compared with definitive radiation therapy (RT) and chemoradiation therapy (CRT). Swallowing toxicities were measured by Dynamic Imaging Grade of Swallowing Toxicity (DIGEST), MD Anderson Dysphagia Inventory (MDADI), and the MD Anderson Symptom Inventory-Head and Neck (MDASI-HN) instruments. The likelihoods of PM/ENE were varied to determine the thresholds within which each therapy remains optimal. Compared with RT, TORS resulted in inferior swallowing function for moderate likelihoods of PM/ENE (>60% in short term for all instruments, >75% in long term for DIGEST and MDASI) leaving RT as the optimal treatment. Compared with CRT, TORS remained the optimal therapy based on MDADI and MDASI but showed inferior swallowing outcomes based on DIGEST for moderate-to-high likelihoods of PM/ENE (>75% for short-term and >40% for long-term outcomes). In the absence of reliable estimation of postoperative PM/ENE concurrent with significant postoperative PM, the overall toxicity level in OPSCC patients undergoing TORS with adjuvant therapy may become more severe compared with patients receiving nonsurgical treatments thus advocating definitive (C)RT protocols.

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

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. 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. 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). 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.

Integration of patient-reported outcomes into survivorship care.

271 Background: Patient reported outcomes (PRO) can be valuable clinical tools to embed the voice of patients into the clinical experience. The use of PROs in the context of cancer survivorship is relatively under-explored. Methods: Disease-specific modules of the MD Anderson Symptom Inventory (MDASI) PRO were integrated into the electronic health record (EHR), and distributed 3-7 days prior to survivorship clinic visits through the patients’ EHR portal. Patients with virtual visits were called 24 hours prior, instructed how to video link, and how to complete the MDASI PRO. For patients who completed the PRO electronically, results were reviewed during clinic visit. High symptom alerts (&gt; = 7) for four key symptoms were established and triggered an automatic message to care teams for review. Results: From Sept 1, 2020 – August 31, 2021, 2,196 PRO surveys were sent to patients with 1,268 submitting results (57.74%) (see Table). Within specific clinics, the submission rates varied greatly between in-person and virtual appointments (33% vs. 83%). Submission rates varied by clinics, with responses ranging from 28.57% - 73.59%. Clinics with higher overall rates had a higher proportion of virtual visits. Conclusions: Electronic distribution of PROs can be successfully integrated into long term survivorship clinic visits. Virtual visits had overall much higher PRO response rates, due to pre-visit workflows which encouraged the completion of PROs. We conclude that patient education and real time support is needed to facilitate patients’ completion of PRO surveys through the electronic portal.[Table: see text]

S726 Fecal Transplantation Improved Patients’ Reported Outcome After Immune Checkpoint Inhibitor Colitis

Introduction: Immune checkpoint inhibitors (ICIs) have become standard treatment for cancers poorly responsive to traditional chemotherapy. The most common GI toxicity of this class of drugs is ICIs colitis (IMC) associated with difficulty to treat chronic diarrhea and risk of fatality. We have previously demonstrated that fecal microbiota transplantation (FMT) was effective in the treatment of a small number of refractory cases suggesting the gut microbiome is involved in the pathogenesis of ICIs colitis. Further large studies are needed to determine its efficacy. Methods: The present study summarizes our experience with FMT treatment of 37 patients with refractory ICIs colitis. We measured the efficacy of FMT and patients’ reported outcome (PRO) via established MD Anderson Symptom Inventory (MDASI). Among them, 9 patients had concurrent CDI as well at the time of diagnosis. (Table) Results: Thirty-seven patients included in our study, with a median age of 59 years and mostly had genitourinary cancers (35.1%) followed by melanoma (27.0%). Most patients had a peak CTCAE diarrhea grade ≥ 3 (91.9%) and colitis grade ≥ 2 (89.1%). Ulcerous (18, 48.6%) and non-ulcerous (12, 32.4%) inflammation was predominant endoscopic findings. 36 (97.3%) patients received corticosteroids, and 33 (89.1%) received add-on infliximab or vedolizumab. IMC symptom response was 83.7% after FMT with median time to response of 5 days. The rate of complications is 16.2% at 7 days and 5.4% at 30 days, and mostly were transient and mild. Response rate among 28 patients without concurrent CDI was 85.7%. Thirty-five (94.6%) patients demonstrated colitis remission at the last follow up. On the PRO analysis, we observed a favorable trend of significant patient-reported symptom reduction on diarrhea during 12 weeks after FMT, along with improved daily physical functioning on working. (Figure) Conclusion: Evidence is accumulating to suggest that efficacy and prevention of ICI related toxicities is dependent upon a healthy diverse microbiome. In the present study, we have shown that FMT achieved 83.7% success rate in patients with IMC with a favorable safety profile. FMT could become a preferred treatment option for the IMC in the future practice.Figure 1.: Patients Reported Outcome Summary Table 1. - Characteristic before FMT No. (%) (n=37) Concurrent CDI# 9 (24.3%) Highest grade of diarrhea of initial IMC onset – no. (%) 1 or 2 3 (8.1%) 3 or 4 34 (91.9%) Highest grade of colitis of initial IMC onset – no. (%) 1 4 (10.8%) 2- 4 33 (89.2%) Initial endoscopic findings – no (%), n=36 Ulcers 18 (48.6%) Non-ulcer inflammation 12 (32.4%) Normal 6 (16.2%) Hospitalizations – no. (%) 29 (78.3%) Median duration of hospitalization – days (IQR) 8 (5-13) Treatment of GI adverse events – no. (%) Steroid 36 (97.3%) Infliximab/vedolizumab added 33 (89.1%) FMT characteristic and outcome Symptom improvement after FMT, all patients – no (%) 31 (83.7%) Symptom improvement after FMT (no concurrent CDI, n=28) – no (%) 24 (85.7%) Median time from FMT to symptom improvement– days (IQR), n=37 5 (2-10) FMT-related complications within 7 days –no (%) 6 (16.2%) FMT-related complications within 30 days –no (%) 2 (5.4%) Colitis status at the end of the study period Clinical remission – no (%) 35 (94.6%) Persistent symptoms – no (%) 2 (5.4%)

Screening and Assessment of Cancer-Related Fatigue: An Executive Summary and Road Map for Clinical Implementation

Background: Cancer-related fatigue (CRF) prevalence is reported as high as 90%. Cancer-related fatigue is multidimensional and associated with lower health-related quality of life. Effective screening and assessment are dependent upon use of valid, reliable, and clinically feasible measures. This Executive Summary of the Screening and Assessment of Cancer-related Fatigue Clinical Practice Guideline provides recommendations for best measures to screen and assess for CRF based on the quality and level of evidence, psychometric strength of the tools, and clinical utility. Methods: After a systematic review of the literature, studies evaluating CRF measurement tools were assessed for quality; data extraction included psychometrics and clinical utility. Measurement tools were categorized as either screens or assessments. Results: Four screens are recommended: European Organization of Research and Treatment of Cancer Quality of Life Questionnaire, the MD Anderson Symptom Inventory, the Distress Thermometer, and the One-Item Fatigue Scale. Eight assessments are recommended: Functional Assessment of Chronic Illness Therapy—Fatigue, Piper Fatigue Scale—Revised, Brief Fatigue Inventory, Cancer Fatigue Scale, Fatigue Symptom Inventory, Patient-Reported Outcome Measurement Information System (PROMIS) Fatigue Short Form and CAT, and Multidimensional Fatigue Inventory-20. Discussion: This Executive Summary is a synopsis of and road map for implementation of the Clinical Practice Guideline for Screening and Assessment of CRF. Review of the full Clinical Practice Guideline is recommended [10.1093/ptj/pzac120]. Additional research focused on responsiveness of instruments is needed in order to consider them for use as outcome measures. Screening and assessing CRF will result in opportunities to improve the quality of life of individuals with cancer.

Patient-reported gastrointestinal symptoms following surgery for gastric cancer and the relative risk factors.

PurposeThe study aims to assess the incidence of short-term patient-reported postoperative gastrointestinal symptoms (PGISs) after gastric cancer surgery and explore the relative risk factors for the symptoms.MethodsPatients with radical gastrectomy were included for this retrospective and observational study. Symptoms extracted from the MD Anderson Symptom Inventory Gastrointestinal Cancer Module (MDASI-GI) were collected in postdischarge week (PDW) 1 and postoperative month (POM) 1. The distributing states of symptoms were analyzed in PDW1 and POM1. Logistic regression models were used to identify risk factors for PGISs.ResultsAmong 356 patients with complete interviews, 156 (43.8%) patients reported abdominal distention in PDW1, which was significantly higher than patients in POM1 [103 (28.9%), p < 0.001]. Pain (15.2% vs. 9.8%), dysphagia (5.6% vs. 7.0%), diarrhea (3.7% vs. 3.4%), and vomiting (2.5% vs. 2.8%) had no significant differences between PDW1 and POM1. Logistic models found that risk factors for PGISs were total gastrectomy [odds ratio (OR): 1.948; 95% CI: 1.097–3.459; p = 0.023] and disturbed sleep (OR: 3.116; 95% CI: 1.831–5.303; p < 0.001) in PDW1 and female gender (OR: 1.726; 95% CI: 1.071–2.782; p = 0.025), total gastrectomy (OR: 1.729; 95% CI: 1.055–2.834; p = 0.030), and disturbed sleep (OR: 3.533; 95% CI: 1.757–7.106; p < 0.001) in POM1.ConclusionsThe main symptom after gastric cancer surgery was abdominal distention. The relative risk factors for gastrointestinal symptoms after gastric cancer surgery were total gastrectomy and disturbed sleep. Timely symptom intervention may improve the quality of life of postgastrectomy patients.

Profiling symptom burden and its influencing factors at discharge for patients undergoing lung cancer surgery: a cross-sectional analysis

BackgroundFollowing lung cancer surgery, patients often experience severe symptoms which are not properly assessed at discharge. The aim of this study was to identify the clinical presentation at discharge and the influencing factors of postoperative symptoms in patients who have undergone lung cancer surgery.MethodsThis cross-sectional study analysed data from patients who participated in a prospective cohort study that enrolled patients who underwent lung cancer surgery at six tertiary hospitals in the People’s Republic of China, from November 2017 to January 2020. Patient symptoms at discharge were measured using the MD Anderson Symptom Inventory Lung Cancer module. The five core symptoms were defined according to ratings of moderate to severe symptoms (≥ 4 on a 0–10 scale). A multivariate linear regression model was used to identify the influencing factors of each symptom at discharge.ResultsAmong the 366 participants, 51.9% were male and the mean (SD) age was 55.81 (10.43) years. At discharge, the core symptoms were cough (36.4%), pain (28.2%), disturbed sleep (26.3%), shortness of breath (25.8%), and fatigue (24.3%), and more than half of the participants (54.6%) had one to five of the core symptoms, with moderate to severe severity. A low annual income and the use of two chest tubes were significantly associated (P = 0.030 and 0.014, respectively) with higher mean scores of the core symptoms.ConclusionThough clinically eligible for discharge, more than half of the participants had severe symptoms at discharge after lung cancer surgery. Special attention should be given to patients who have two chest tubes after surgery and those who have a low annual income.

124. LONGITUDINAL STUDY OF POSTOPERATIVE SYMPTOMS AND QUALITY OF LIFE IN PATIENTS WITH ESOPHAGEAL SQUAMOUS CELL CARCINOMA

Abstract Patients with esophageal squamous cell carcinoma have a variety of symptoms after surgery, which will affect the normal performance of various functions of patients for a long time, affect the quality of life of patients, and even affect the survival time of patients. In the past, we paid more attention to patients’ symptoms and quality of life at a single time point after surgery, which lacked continuity and long-term nature. In this study, 244 patients with esophageal squamous cell carcinoma who received thoracoscopic radical resection of esophageal carcinoma in Sichuan Tumor Hospital from April to December 2019 were selected by convenience sampling method. Adopt Chinese VERSION MD Anderson Symptom Inventory, European Organization for Research and teatment of cancer quality of life Questionnaire, EORTC QLQ-C30 and QLQ-OES18 were used to investigate the patients at 10 time points one year after surgery, and Pearson correlation analysis was used to analyze the correlation between postoperative symptoms and quality of life. Postoperative role and emotional function of the patients recovered to the baseline level 1 month after surgery, cognitive and social function recovered to the baseline level 3 months after surgery, and physical function and overall health status did not recover to the baseline level 1 year after surgery. Sleep restlessness, distress, drowsiness, and dry mouth recovered to baseline 3 months after surgery, while pain and fatigue did not recover to baseline 1 year after surgery. One year after surgery, the main symptoms were negatively correlated with body, role, emotion, cognition, social function and overall health status (P &amp;lt; 0.05). laparoscopic thoracic esophageal cancer radical surgery in patients with esophageal squamous cell carcinomas there were different degree of symptoms within one year after surgery, and multiple symptoms one year after surgery still exists, the serious influence the patient’s quality of life, health care workers should pay attention to the symptoms of patients with postoperative longitudinal change characteristic, value assessment and management of patients with symptoms, improve patient quality of life after surgery.

Patient-reported symptom burden in patients with rare cancers receiving pembrolizumab in a phase II Clinical Trial

Patients with rare solid tumors treated on early phase trials experience toxicities from their tumors and treatments. However, limited data exist to describe the detailed symptom burden suffered by these patients, particularly those with rare solid tumors treated with immunotherapy. We performed a prospective longitudinal study to capture patient-reported symptom burden. Patients completed the validated MD Anderson Symptom Inventory (MDASI)—Immunotherapy with 20 symptoms including 7 immunotherapy-specific items and 6 interference items at baseline and weekly thereafter for up to 9 weeks. Symptoms and interference were rated on 0–10 scales (0 = none or no interference, 10 = worst imaginable or complete interference). Group-based trajectory modelling determined higher and lower symptom groups. A total of 336 MDASI questionnaires were completed by 53 patients (mean age 55.4y, 53% male) with advanced rare cancers receiving pembrolizumab in a Phase II clinical trial. Symptoms reported as most severe over the course of the treatment over 9 weeks were fatigue [mean (M) = 3.8, SD = 2.3], pain (M = 3.7, SD = 2.9), disturbed sleep (M = 2.7, SD = 2.3), drowsiness (M = 2.6, SD = 2.0) and lack of appetite (M = 2.5, SD = 2.1). Pain in the abdomen (M = 2.2, SD = 2.4), rash (M = 1.1, SD = 1.8) and diarrhea (M = 0.9, SD = 1.5) were less severe. Interference with walking was rated the highest (M = 3.4, SD = 2.8) and relations with others was rated the lowest (M = 2.1, SD = 2.6). Using a composite score based on the five most severe symptoms (fatigue, pain, lack of appetite, feeling drowsy and sleep disturbance), 43% were classified into the high symptom burden group. Using a score based on immunotherapy-specific symptoms (e.g., rash, diarrhea) 33% of patients were included in the high symptom group. Symptom burden stayed relatively stable in the high- and low-symptom burden patient groups from baseline through 9 weeks. Some patients with rare malignancies experienced high symptom burden even at baseline. In patients with rare cancers, symptom trajectories stayed relatively stable over nine weeks of treatment with pembrolizumab.Trial registration: ClinicalTrials.gov identifier: NCT02721732.

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

Simple SummaryPatients’ perspectives should be incorporated into the perioperative care plan in patients with bladder cancer undergoing cystectomy. Our approach incorporated both patients’ perspectives and clinicians’ points of view to develop and validate the MDASI-PeriOp-BLC module. The MDASI-PeriOp-BLC module was found to be a valid, reliable, and concise tool to assess symptom burden and functional recovery in this specific cohort of patients.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.

Feasibility and Acceptability of Implementing Site-Specific Patient-Reported Outcome Measure in Head and Neck Cancer Clinics: A Prospective Institutional Study

PurposeTo assess the feasibility and acceptability of implementing the MD Anderson Symptom Inventory–Head and Neck (MDASI-HN) module in cancer clinics and its effect on patient-reported experience. MethodsWe conducted a prospective, longitudinal study at a tertiary cancer institution between September 2020 and August 2021. Patients with newly diagnosed head and neck (HN) cancer who were evaluated to receive radiation therapy with or without chemotherapy and could communicate in English were approached to participate. The primary outcome was feasibility and acceptability of the MDASI-HN implementation in the radiation oncology department assessed by patient and provider exit surveys. Secondary outcomes were patient-reported experience as recorded by a shortened Your Voice Matters survey (YVM) in 2 cohorts pre- and post-MDASI-HN implementation and symptom scores. Descriptive statistics were used for exit surveys and symptom scores. Mann-Whitney tests were used to assess differences in positive responses between pre- and postimplementation for each YVM question. Cochrane-Armitage tests were used to examine changes in patient-reported experience over time. ResultsFifty-one patients were enrolled in the postimplementation cohort and 29 (60%) responded to the exit survey. Eighty-nine percent of patients reported that MDASI-HN made it easier to remember symptoms, and 86% recommend its use in routine care. Four of the 5 radiation oncology HN providers (80%) responded to exit surveys; 75% felt the MDASI-HN provided clinically relevant information, improved communication with patients, and did not increase clinic time. The overall patient-reported experience was not affected by the implementation (P = .82). The probability of positive responses over time was significant (P = .025) in the clinic coordination domain for the postimplementation cohort. ConclusionsImplementation of MDASI-HN was feasible and acceptable by patients and providers. Although the overall patient-reported experience was not affected by implementation, some aspects improved as treatment progressed.

Responder Analysis of Pain Relief After Surgery for the Treatment of Spinal Metastatic Tumors.

Central tendency analysis studies demonstrate that surgery provides pain relief in spinal metastatic tumors. However, they preclude patient-specific probability of treatment outcome. To use responder analysis to study the variability of pain improvement. In this single-center, retrospective analysis, 174 patients were studied. Logistic regression modeling was used to associate preoperative characteristics with rating the Brief Pain Inventory (BPI) worst pain item 0 to 4. Linear regression modeling was used to associate preoperative characteristics with minimal clinically important improvement (MCI) in physical functioning defined by a 1-point decrease in the BPI Interference Construct score from preoperative baseline to 6 months postoperatively. Patient-level analysis revealed that 60% of patients experienced an improvement in pain. At least half experienced a decrease in pain resulting in MCI in physical functioning. Cutpoint analysis revealed that 48% were responders. Increasing scores on the preoperative pain intensity BPI items, the MD Anderson Symptom Inventory (MDASI) Core Symptom Severity Construct, the MDASI Spine Tumor-Specific Construct, the presence of preoperative neurologic deficits, and postoperative complications were associated with lower probability of treatment success while increasing severity in all BPI pain items, and MDASI constructs were associated with increased probability of MCI in physical function. Significant mortality and loss to follow-up intrinsic to this patient population limit the strength of these data. Although patients with milder preoperative symptoms are likely to achieve better pain relief after surgery, patients with worse preoperative symptom also benefit from surgery with adequate pain relief with an improvement in physical function.