Development of a Strategic Initiative at MD Anderson Cancer Center to Improve Outcomes in Immune-Related Adverse Events.

Immune checkpoint inhibitors (ICIs) have transformed the treatment paradigm for many cancer types. The clinical use of ICIs is increasing rapidly, including in combinations associated with increased risk of toxicities, termed "immune-related adverse events" (irAEs). Therefore, MD Anderson Cancer Center (MDACC) in Houston, Texas has proactively responded by developing a priority endeavor known as the Immuno-Oncology Toxicity (IOTOX) initiative. This strategic initiative aims to facilitate the seamless integration of key domains: (1) standardized clinical practice and innovative decision toolsets; (2) patient and provider education; and (3) a comprehensive clinical and translational research platform. The ultimate goal of this initiative is to develop and disseminate clinical best practices and biologic insights into irAEs to improve outcomes of patients with irAEs at MDACC and in the wider oncology community.

Patient characteristics associated with sleep disturbance in breast cancer survivors.

BACKGROUND: Disturbed sleep is common among breast cancer survivors. Identifying patients at risk for disturbed sleep and its sequelae will aid in improving screening and intervention strategies to improve sleep and cancer-related quality of life (QOL). METHODS: Women with stages I-III breast cancer undergoing neoadjuvant or adjuvant chemotherapy (N = 415) reported subjectively assessed sleep quality (PSQI) and actigraphy-assessed wake after sleep onset (AAS-WASO), total sleep time (AAS-TST), and sleep efficiency (AAS-SE), sociodemographic, and clinical characteristics and completed questionnaires assessing physical and mental health QOL at study entry and 3, 6, 12, and 15 months later. RESULTS: Being from a racially/ethnically underserved population was associated with poorer sleep in all indices (p's < .04). Lower income was associated with poorer subjective sleep and greater AAS-WASO (p's < .02). BMI was associated with lower AAS-SE (p < .001). Baseline subjective sleep complaints were positively associated with depression, fatigue, and health-related QOL and cancer-related symptoms across follow-up (p's < 0.05). Baseline AAS-WASO was positively associated with anxiety and negatively associated with physical health-related QOL at the 3-month follow-up (p's < .001). Baseline AAS-WASO and AAS-SE were associated with mental health-related QOL at the 6-month follow-up (p's < .05). CONCLUSIONS: In keeping with previous health disparity research, racially/ethnically underserved populations, lower household income, and higher BMI were associated with increased risk for disturbed sleep. Sleep disturbance may have long-term effects on multiple aspects of QOL for women undergoing treatment for breast cancer. Results may inform strategies to identify patients at greatest risk for disturbed sleep and its sequelae.

Randomized trial of Tibetan yoga in patients with breast cancer undergoing chemotherapy.

BACKGROUND: The current randomized trial examined the effects of a Tibetan yoga program (TYP) versus a stretching program (STP) and usual care (UC) on sleep and fatigue in women with breast cancer who were undergoing chemotherapy. METHODS: Women with stage (American Joint Committee on Cancer (AJCC) TNM) I to III breast cancer who were undergoing chemotherapy were randomized to TYP (74 women), STP (68 women), or UC (85 women). Participants in the TYP and STP groups participated in 4 sessions during chemotherapy, followed by 3 booster sessions over the subsequent 6 months, and were encouraged to practice at home. Self-report measures of sleep disturbances (Pittsburgh Sleep Quality Index), fatigue (Brief Fatigue Inventory), and actigraphy were collected at baseline; 1 week after treatment; and at 3, 6, and 12 months. RESULTS: There were no group differences noted in total sleep disturbances or fatigue levels over time. However, patients in the TYP group reported fewer daily disturbances 1 week after treatment compared with those in the STP (difference, -0.43; 95% confidence interval [95% CI], -0.82 to -0.04 [P = .03]) and UC (difference, -0.41; 95% CI, -0.77 to -0.05 [P = .02]) groups. Group differences at the other time points were maintained for TYP versus STP. Actigraphy data revealed greater minutes awake after sleep onset for patients in the STP group 1 week after treatment versus those in the TYP (difference, 15.36; 95% CI, 7.25-23.48 [P = .0003]) and UC (difference, 14.48; 95% CI, 7.09-21.87 [P = .0002]) groups. Patients in the TYP group who practiced at least 2 times a week during follow-up reported better Pittsburgh Sleep Quality Index and actigraphy outcomes at 3 months and 6 months after treatment compared with those who did not and better outcomes compared with those in the UC group. CONCLUSIONS: Participating in TYP during chemotherapy resulted in modest short-term benefits in sleep quality, with long-term benefits emerging over time for those who practiced TYP at least 2 times a week. Cancer 2018;124:36-45. © 2017 American Cancer Society.

Qigong/tai chi for sleep and fatigue in prostate cancer patients undergoing radiotherapy: a randomized controlled trial.

OBJECTIVES: Sleep disturbances and fatigue are common in prostate cancer patients undergoing radiotherapy. Prior research suggests mind-body techniques may improve these outcomes. We conducted a randomized controlled trial of qigong/tai chi (QGTC) in men with prostate cancer undergoing radiotherapy. METHODS: Men with prostate cancer starting definitive radiation were randomized to 1 of 3 groups: (1) QGTC; (2) light exercise (LE); or (3) waiting list control. Sleep disturbances (Pittsburgh Sleep Quality Index) and fatigue (Brief Fatigue Inventory) were assessed at baseline, midway through radiotherapy (T2), during the last week of radiotherapy (T3), and at 1 (T4) and 3 months (T5) after the end of radiotherapy. Patients in the QGTC and LE groups attended three 40-minute classes per week throughout radiotherapy. RESULTS: Ninety patients were randomized to the 3 groups (QGTC = 26; LE = 26; waiting list control = 24). The QGTC group reported longer sleep duration midway through radiotherapy (QGTC = 7.01 h; LE = 6.42; WL = 6.50; P = .05), but this difference did not persist over time. There were no group differences in other domains of sleep or fatigue. Exploratory analyses conducted to examine the effect of health-related quality of life (Expanded Prostate Cancer Index Composite and American Urological Association Symptom score) on sleep and fatigue showed significant correlations across multiple domains. CONCLUSIONS: Qigong/tai chi during radiation for prostate cancer resulted in superior sleep duration midway through radiation, but this effect was not durable, and there were no differences in other domains of sleep or fatigue. Exploratory analysis demonstrated that both sleep and fatigue were highly correlated with prostate cancer-related physical symptoms. Future mind-body intervention studies should incorporate multimodal therapy focused on improving physical symptoms in this population.

Examination of moderators of expressive writing in patients with renal cell carcinoma: the role of depression and social support.

OBJECTIVE: To identify groups most likely to benefit from an Expressive Writing (EW) intervention, we examined psychosocial variables as intervention moderators. We hypothesized that EW would be particularly effective for participants with high levels of depressive symptoms and social support at study entry. METHODS: Patients (n = 277; 60.6% male) with kidney cancer were randomly assigned to either an expressive (EW) or neutral writing (NW) condition. Intervention outcomes included measures of depressive symptoms (CESD), cancer-related symptoms (MDASI), fatigue (BFI), and sleep disturbances (PSQI) assessed at baseline, 1, 4, and 10 months later. Moderators were measured at baseline. RESULTS: As hypothesized, depressive symptoms and social support moderated intervention efficacy. When examining both moderators simultaneously, EW appeared to be most effective in terms of cancer-related symptoms (p < 0.05) and depressive symptoms (p < 0.01) for participants with elevated depressive symptoms who received high levels of social support at baseline relative to their counterparts in the NW condition. Moreover, participants in EW with high levels of social support at baseline reported lower levels sleep disturbances (p = 0.005) than their counterparts in NW. CONCLUSIONS: Recognition of baseline depressive symptoms and social support as intervention moderators may lead to improved patient selection for EW interventions, as EW may be particularly beneficial regarding QOL outcomes for patients that have social support available including participants with depressive symptoms. EW may not be beneficial, or potentially even contraindicated, for participants lacking social support. Copyright © 2016 John Wiley & Sons, Ltd.

The effects of oncology massage on symptom self-report for cancer patients and their caregivers.

BACKGROUND: Massage has shown benefit for symptomatic relief in cancer patients and their caregivers. We explored the effects of a single massage session on self-reported symptoms in an outpatient clinic at a comprehensive cancer center. METHODS: Patients and caregivers receiving oncology massage treatments (30 or 60-min duration) at our Integrative Medicine Center outpatient clinic from September 2012 to January 2015 completed the Edmonton Symptom Assessment Scale (ESAS; 0-10 scale, 10 most severe) pre and post massage. ESAS individual items and subscales of physical distress (PHS), psychological distress (PSS), and global distress (GDS) were analyzed. We used paired t tests with a p value correction (i.e., p < .001) to examine symptoms pre/post massage. RESULTS: Initial massage visits for 343 patients and 87 caregivers were analyzed. The highest symptom burdens (means) at baseline for patients were sleep 4.22, fatigue 3.57, and pain 2.94; for caregivers, sleep 3.77, well-being 3.01, and pain 2.59. Although patients reported significantly greater global distress and physical symptoms (p < .0001) compared to caregivers at baseline, groups did not differ in regard to psychological symptom burden (p = .66) and individual symptom scores (e.g., pain, sleep, spiritual pain). Massage therapy was associated with statistically (p < .0001) and clinically significant improvements in symptoms of pain, fatigue, anxiety, well-being, and sleep and ESAS subscales for both patients and caregivers. Greater massage duration (30 vs 60 min) did not lead to greater symptom reduction. CONCLUSIONS: Patients and caregivers reported a moderately high symptom burden. A single massage treatment resulted in acute relief of self-reported symptoms in both groups. Further study is warranted regarding optimal massage dose and frequency.

Randomized, placebo-controlled trial of K1 acupoint acustimulation to prevent cisplatin-induced or oxaliplatin-induced nausea.

BACKGROUND: Greater than 70% of patients with cancer experience chemotherapy-induced nausea and vomiting. In the current study, the authors examined the effects of electrostimulation of the K1 acupoint located on the sole of the foot because it is believed to have the potential to control chemotherapy-induced nausea and vomiting. METHODS: In this trial, 103 patients diagnosed with primary or metastatic liver cancer were recruited before transcatheter arterial infusion (TAI) of cisplatin or oxaliplatin and randomized to either group A (51 patients who were treated with the antiemetic tropisetron and acustimulation at the K1 acupoint for 20 minutes approximately 1 to 2 hours before TAI on the first day and then daily for the subsequent 5 days) or group B (52 patients who were treated with tropisetron and electrostimulation at a placebo point on the heel). The rate, intensity, and duration of nausea and vomiting were collected at baseline and then daily for 5 days after TAI. Quality of life was assessed daily using the MD Anderson Symptom Inventory and the EuroQoL scale. RESULTS: No differences were found between groups A and B with regard to the incidence and degree of nausea or vomiting on day 1 or the following 5 days. Patients in group A had better EuroQoL scores compared with patients in group B (72.83 in group A vs 65.94 in group B; P =.04) on day 4 but not on the other days. No group differences were noted at any time point for MD Anderson Symptom Inventory scores. CONCLUSIONS: Electrostimulation of K1 combined with antiemetics did not result in initial prevention of cisplatin-induced or oxaliplatin-induced nausea or vomiting.

Posttraumatic stress and depressive symptoms in renal cell carcinoma: association with quality of life and utility of single-item distress screening.

OBJECTIVE: The purpose of this study was to examine the prevalence of posttraumatic stress symptoms (PTSS) in patients with renal cell carcinoma (RCC), the associations and co-occurrence between PTSS, depressive, and other cancer-related symptoms and the ability of a single-item distress question to identify patients with PTSS. METHODS: Patients with stage I-IV RCC completed assessments of depressive symptoms (Center for Epidemiologic Studies Depression Scale), PTSS (Impact of Event Scale), cancer-related symptoms (MD Anderson Symptom Inventory), fatigue (Brief Fatigue Inventory), and sleep disturbance (Pittsburgh Sleep Quality Index). We used the distress item on the MD Anderson Symptom Inventory as a distress screener and general linear model analyses to test study hypotheses. RESULTS: Of the 287 patients (29% stage IV; 42% female; mean age = 58 years), 46% (n = 131) reported psychiatric symptoms with 15% (n = 44) reporting comorbid clinical levels of depressive symptoms and PTSS, 24% (n = 70) PTSS alone, and 6% (n = 17) depressive symptoms alone. Controlling for age, gender, and stage, patients with comorbid depressive symptoms and PTSS reported more cancer-related symptoms (p < 0.0001), fatigue (p < 0.0001), and sleep disturbance (p = 0.0003) than those with PTSS alone and more cancer-related symptoms (p = 0.002) and fatigue (p = 0.09) than those with depressive symptoms alone. Sensitivity analyses revealed that 26.9% of negative cases on the distress item fell within the clinical range of the Impact of Event Scale and 9.3% of negative cases met caseness on the Center for Epidemiologic Studies Depression Scale. CONCLUSIONS: Posttraumatic stress symptoms occurred both independently and comorbid with depressive symptoms in patients with RCC. PTSS were correlated with overall cancer symptom burden. Single-item distress screening was less sensitive in detecting PTSS than depressive symptoms. Therefore, additional screening strategies are required in the clinical setting.

Efficacy and clinicogenomic correlates of response to immune checkpoint inhibitors alone or with chemotherapy in non-small cell lung cancer.

The role of combination chemotherapy with immune checkpoint inhibitors (ICI) (ICI-chemo) over ICI monotherapy (ICI-mono) in non-small cell lung cancer (NSCLC) remains underexplored. In this retrospective study of 1133 NSCLC patients, treatment with ICI-mono vs ICI-chemo associate with higher rates of early progression, but similar long-term progression-free and overall survival. Sequential vs concurrent ICI and chemotherapy have similar long-term survival, suggesting no synergism from combination therapy. Integrative modeling identified PD-L1, disease burden (Stage IVb; liver metastases), and STK11 and JAK2 alterations as features associate with a higher likelihood of early progression on ICI-mono. CDKN2A alterations associate with worse long-term outcomes in ICI-chemo patients. These results are validated in independent external (n = 89) and internal (n = 393) cohorts. This real-world study suggests that ICI-chemo may protect against early progression but does not influence overall survival, and nominates features that identify those patients at risk for early progression who may maximally benefit from ICI-chemo.

Predicting benefit from immune checkpoint inhibitors in patients with non-small-cell lung cancer by CT-based ensemble deep learning: a retrospective study.

BACKGROUND: Only around 20-30% of patients with non-small-cell lung cancer (NCSLC) have durable benefit from immune-checkpoint inhibitors. Although tissue-based biomarkers (eg, PD-L1) are limited by suboptimal performance, tissue availability, and tumour heterogeneity, radiographic images might holistically capture the underlying cancer biology. We aimed to investigate the application of deep learning on chest CT scans to derive an imaging signature of response to immune checkpoint inhibitors and evaluate its added value in the clinical context. METHODS: In this retrospective modelling study, 976 patients with metastatic, EGFR/ALK negative NSCLC treated with immune checkpoint inhibitors at MD Anderson and Stanford were enrolled from Jan 1, 2014, to Feb 29, 2020. We built and tested an ensemble deep learning model on pretreatment CTs (Deep-CT) to predict overall survival and progression-free survival after treatment with immune checkpoint inhibitors. We also evaluated the added predictive value of the Deep-CT model in the context of existing clinicopathological and radiological metrics. FINDINGS: Our Deep-CT model demonstrated robust stratification of patient survival of the MD Anderson testing set, which was validated in the external Stanford set. The performance of the Deep-CT model remained significant on subgroup analyses stratified by PD-L1, histology, age, sex, and race. In univariate analysis, Deep-CT outperformed the conventional risk factors, including histology, smoking status, and PD-L1 expression, and remained an independent predictor after multivariate adjustment. Integrating the Deep-CT model with conventional risk factors demonstrated significantly improved prediction performance, with overall survival C-index increases from 0·70 (clinical model) to 0·75 (composite model) during testing. On the other hand, the deep learning risk scores correlated with some radiomics features, but radiomics alone could not reach the performance level of deep learning, indicating that the deep learning model effectively captured additional imaging patterns beyond known radiomics features. INTERPRETATION: This proof-of-concept study shows that automated profiling of radiographic scans through deep learning can provide orthogonal information independent of existing clinicopathological biomarkers, bringing the goal of precision immunotherapy for patients with NSCLC closer. FUNDING: National Institutes of Health, Mark Foundation Damon Runyon Foundation Physician Scientist Award, MD Anderson Strategic Initiative Development Program, MD Anderson Lung Moon Shot Program, Andrea Mugnaini, and Edward L C Smith.

Randomized controlled trial of acupuncture for prevention of radiation-induced xerostomia among patients with nasopharyngeal carcinoma.

BACKGROUND: Xerostomia (dry mouth) after head/neck radiation is a common problem among cancer patients, and available treatments are of little benefit. The objective of this trial was to determine whether acupuncture can prevent xerostomia among head/neck patients undergoing radiotherapy. METHODS: A randomized, controlled trial among patients with nasopharyngeal carcinoma was conducted comparing acupuncture to standard care. Participants were treated at Fudan University Shanghai Cancer Center, Shanghai, China. Forty patients were randomized to acupuncture treatment and 46 to standard care. Patients were treated 3×/wk on the same days they received radiotherapy. Subjective measures included the Xerostomia Questionnaire and MD Anderson Symptom Inventory-Head and Neck (MDASI-HN). Objective measures were unstimulated and stimulated whole salivary flow rates. Patients were followed for 6 months after the end of radiotherapy. RESULTS: Xerostomia Questionnaire scores for acupuncture were statistically significantly lower than for controls starting in week 3 through the 6 months (P = .003 at week 3, all other P < .0001), with clinically significant differences as follows: week 11, relative risk (RR) 0.63 (95% confidence interval [CI], 0.45-0.87); 6 months, RR 0.38 (95% CI, 0.19-0.76). Similar findings were seen for MDASI-HN scores. Group differences emerged as early as 3 weeks into treatment for saliva (unstimulated whole salivary flow rate, P = .0004), with greater saliva flow in the acupuncture group at week 7 (unstimulated whole salivary flow rate, P < .0001; stimulated whole salivary flow rate, P = .002) and 11 (unstimulated whole salivary flow rate, P < .02; stimulated whole salivary flow rate, P < .03) and at 6 months (stimulated whole salivary flow rate, P < .003). CONCLUSIONS: Acupuncture given concurrently with radiotherapy significantly reduced xerostomia and improved quality of life.

Limited Benefit from the Addition of Immunotherapy to Chemotherapy in TKI-Refractory EGFR-Mutant Lung Adenocarcinoma.

BACKGROUND: The benefit of chemotherapy combined with immunotherapy in EGFR-mutant lung adenocarcinoma (LUAD) patients whose tumor developed resistance to EGFR tyrosine kinase inhibitors (TKIs) is not thoroughly investigated. The goal of this retrospective cohort study is to assess the clinical efficiency of immunotherapy alone or in combination with chemotherapy in a real-world setting. METHODS: This retrospective cohort study enrolled LUAD patients with EGFR sensitive mutations whose tumor had acquired resistance to EGFR TKIs and received systemic treatment with chemotherapy (chemo; n = 84), chemotherapy combined with immunotherapy (chemoIO; n = 30), chemotherapy plus bevacizumab with or without IO (withBev; n = 42), and IO monotherapy (IO-mono; n = 22). Clinical progression-free survival (PFS) and overall survival (OS) were evaluated. Associations of clinical characteristics with outcomes were assessed using univariable and multi-covariate Cox Proportional Hazards regression models. RESULTS: A total of 178 patients (median age = 63.3; 57.9% females) with a median follow-up time of 42.0 (Interquartile range: 22.9-67.8) months were enrolled. There was no significant difference in PFS between chemoIO vs. chemo groups (5.3 vs. 4.8 months, p = 0.8). Compared to the chemo group, patients who received withBev therapy trended towards better PFS (6.1 months vs. 4.8; p = 0.3; HR 0.79; 95% CI: 0.52-1.20), while patients treated with IO-mono had inferior PFS (2.2 months; p = 0.001; HR 2.22; 95% CI: 1.37-3.59). Furthermore, PD-L1 level was not associated with PFS benefit in the chemoIO group. Patients with EGFR-mutant LUAD with high PD-L1 (≥50%) had shorter PFS (5.8 months) than non-EGFR/ALK LUAD patients who received chemoIO (12.8 months, p = 0.002; HR 0.22; 95% CI: 0.08-0.56) as first-line treatment. Chemotherapy-based therapy rendered similar benefit to patients with either EGFR exon19 deletion vs. L858R in the LUAD. CONCLUSIONS: This retrospective analysis revealed that immunotherapy provided limited additional benefit to chemotherapy in TKI-refractory EGFR-mutant LUAD. Chemotherapy alone or combined with bevacizumab remain good choices for patients with actionable EGFR mutations.

Concurrent use of aspirin with osimertinib is associated with improved survival in advanced EGFR-mutant non-small cell lung cancer.

BACKGROUND: Osimertinib is the treatment of choice for advanced EGFR-mutant non-small cell lung cancer (NSCLC). However, novel strategies to improve the duration of disease control are still urgently needed. Aspirin has been shown to decrease cancer incidence and improve outcomes in various malignancies. Therefore, we evaluated a cohort of patients who received osimertinib with or without concurrent use of aspirin to assess whether the addition of aspirin may lead to improved clinical outcomes. METHODS: MD Anderson Cancer Center GEMINI database was retrospectively queried for EGFR-mutant NSCLC patients who received osimertinib with or without concurrent use of aspirin for progression-free survival (PFS) and overall survival (OS). RESULTS: A total of 365 patients were identified including 77 which had concurrent use of aspirin. Patients in the aspirin-osimertinib group had significantly improved PFS (21.3 vs 11.6 months; HR, 0.52; 95 % CI, 0.38-0.70) and OS (Not reached vs 32.3 months; HR, 0.56; 95 % CI, 0.35-0.91) compared to osimertinib group. In subgroup analyses, the aspirin-associated PFS benefit was observed in patients with and without central nervous system (CNS) metastases, as well as in osimertinib first-line setting and in subsequent line setting. The median PFS in EGFR 19Del patients was longer than EGFR L858R patients with osimertinib, and when aspirin was added, the median PFS significantly improved in both groups regardless of lines of therapy. The benefit from aspirin was independent of age, gender, TP53 mutational status, or PD-L1 positivity. CONCLUSION: Concurrent aspirin use with osimertinib in EGFR-mutant NSCLC patients was associated with improved survival, regardless of lines of therapy, CNS metastatic status, EGFR mutation type, age, gender, TP53, and PD-L1 status.

A Randomized Controlled Trial of Brief Mindfulness Meditation for Women Undergoing Stereotactic Breast Biopsy.

PURPOSE: Stereotactic breast biopsy (SBB) is a common, anxiety-producing procedure. Nonpharmacologic methods to manage acute anxiety are needed. METHODS: In this single-blind trial, women were recruited before SBB and randomized in a 2:2:1 ratio to a single session of guided mindfulness-based meditation (GM; n = 30), focused breathing (FB; n = 30), or standard care (SC; n = 16). Anxiety and pain were assessed at baseline after a 10-min prebiopsy group-specific activity (GM, FB, or SC), every 4 min during SBB, and after biopsy. Electroencephalographic activity in the medial prefrontal cortex, insula, anterior cingulate cortex, and precuneus was collected throughout the study. RESULTS: Women in the GM group reported a steeper reduction in anxiety than women in the FB and SC groups (P < .001 for all, Cohen's d > 0.4 for all). There were no group differences in pain ratings during the biopsy. Women in the GM group experienced increased beta activity during biopsy in the insula (P = .006, Cohen's d = 1.4) and anterior cingulate cortex (P = .019, Cohen's d = 1.0) compared with women in the SC group, and there was a trend toward the same effect compared with women in the FB group (P < .10 for both). Women in the GM and FB groups experienced a nonsignificant decrease in delta activity in the precuneus during biopsy compared with those in the SC group (P < .40 for both, Cohen's d > 0.6 for both), which was associated with a steeper reduction in anxiety during the biopsy (r = 0.51, P < .01). CONCLUSIONS: Brief, guided meditation may provide effective anxiety relief during an acute medical procedure and affect neuronal activity in regions associated with attention, self-awareness, and emotion regulation.

Inpatient Acupuncture at a Major Cancer Center.

BACKGROUND: Use of complementary and integrative therapies is increasing among cancer patients, but data regarding the impact treatments such as acupuncture have in an inpatient oncology setting are limited. METHODS: Patients who received acupuncture in an inpatient hospital environment between December 2014 and December 2015 were asked to complete a modified Edmonton Symptom Assessment Scale (ESAS; 0-10 scale) before and after each visit. Pre- and post-treatment scores were examined for each symptom using paired t tests. RESULTS: A total of 172 inpatients were treated with acupuncture in their hospital beds (257 visits). Thirty percent (n = 51) received at least one additional follow-up treatment (mean visits/patient = 1.5). Completion rate of the modified ESAS after acupuncture was 42%. The most common reasons for not completing the post-treatment ESAS were "patient too drowsy" or "patient fell asleep" (72%). For patients who reported a baseline symptom score ≥1, the greatest improvements (mean change ± SD) after acupuncture on the initial visit were found for pain (-1.8 ± 2.2; n = 69; P < .0001), nausea (-1.2 ± 1.9; n = 30; P < .001), anxiety (-0.8 ± 1.8; n = 36; P = .01), drowsiness (-0.6 ± 1.8; n = 57; P = .02), and fatigue (-0.4 ± 1.1; n = 67; P = .008). For patients who received at least one follow-up visit, significant improvement from baseline was found for sleep disturbance (-2.5 ± 4.4; n = 17; P = .03), anxiety (-2.4 ± 1.7; n = 9; P = .002), pain (-2.3 ± 2.7; n = 20; P = .001), and drowsiness (-2.0 ± 2.6; n = 16; P = .008). CONCLUSIONS: Patients who received inpatient acupuncture at a major cancer center experienced significant improvement after treatment for pain, sleep disturbance, anxiety, drowsiness, nausea, and fatigue.

A Pragmatic Evaluation of Symptom Distress After Group Meditation for Cancer Patients and Caregivers: A Preliminary Report.

CONTEXT: Complementary health approaches such as meditation may help improve cancer patient and caregiver symptoms, yet little research has examined the clinical application of these programs. OBJECTIVES: We explored the effects of a meditation group class, offered as part of an integrative medicine clinic at a comprehensive cancer center, on patient and caregiver self-reported symptoms. METHODS: Participants (patients and caregivers) of any three meditation group classes offered-Power of Breath (PB), Sacred Sounds (SS), and Movement & Breath (MB)-were asked to complete the Edmonton Symptom Assessment Scale (ESAS; scale 0-10, 10 most severe) before and after participation. ESAS individual items and subscales were analyzed; distress subscales included global (global distress score 0-90), physical (physical distress score 0-60), and psychological (psychological distress score, 0-20). Data were analyzed examining premeditation/postmeditation scores using paired t-tests and between types of meditation using analyses of variance. RESULTS: One hundred forty-two unique participants (76 patients and 66 caregivers) attended one or more meditation groups (mean 1.84) from May to December 2015 (265 total attendance: PB n = 92; SS n = 87; MB n = 86). For all participants, we observed clinically significant reduction/improvement in global distress scores (-5.17, SD 8; P < 0.0001) and in individual symptoms (ESAS decrease ≥ 1; means) of well-being (-1.36 SD 1.7; P < 0.0001), fatigue (-1.34 SD 1.9; P < 0.0001), anxiety (-1.26 SD 1.6; P < 0.001), and shortness of breath (-1.2 SD 2; P = 0.001). Comparing class length (60 vs. 90 minutes), class content (PB vs. SS vs. MB), and participants (caregivers vs. patients), there were no statistically significant differences in symptom score reduction. CONCLUSION: A single meditation group class offered as part of clinical care resulted in relief of multiple self-reported symptoms in both patients and caregivers.

Yoga Program for High-Grade Glioma Patients Undergoing Radiotherapy and Their Family Caregivers.

BACKGROUND: Despite their high symptom burden and poor prognosis, evidence-based supportive care interventions for adults with high-grade glioma (HGG) and their caregivers are lacking. Thus, we aimed to establish feasibility of a patient-caregiver dyadic yoga program (DYP) for newly diagnosed HGG patients and their family caregivers targeting quality-of-life (QOL) outcomes. METHOD: In this single-arm pilot trial, dyads participated in a 12-session DYP program across the course of patients' radiotherapy. The intervention focused on breathing exercises, gentle movements, and guided meditations. We tracked feasibility data and assessed levels of cancer-related symptoms (MD Anderson Symptom Inventory [MDASI]), depressive symptoms (Centers for Epidemiological Studies-Depression scale), fatigue (Brief Fatigue Inventory), sleep disturbances (Pittsburgh Sleep Quality Index [PSQI]), and overall mental and physical QOL (36-item Short-Form Survey [SF-36]) at baseline and post-DYP, which was at the end of radiotherapy. RESULTS: We approached 6 dyads of which 5 dyads (86%) consented and completed all 12 sessions and pre/post assessments. All patients (mean age: 52 years, 80% female, 80% grade IV) and caregivers (mean age: 58 years, 80% female, 60% spouses) perceived benefit from the program. Paired t tests revealed a marginally significant, yet clinically meaningful, decrease in patient's cancer symptoms ( t = 2.32, P = .08; MDASI mean; pre = 1.75, post = 1.04). There were clinically significant reductions in patient sleep disturbances (PSQI mean: pre = 10.75, post = 8.00) and improvements in patient and caregiver mental QOL (MCS of SF-36 mean: pre = 42.35, post = 52.34, and pre = 45.14, post = 51.43, respectively). CONCLUSIONS: This novel supportive care program appears to be safe, feasible, acceptable, and subjectively useful for HGG patients and their caregivers. There was also preliminary evidence regarding QOL treatment gains for both patients and caregivers.

Integrative Oncology Outpatient Consultations: Long-Term Effects on Patient-Reported Symptoms and Quality of Life.

Background: Integrative oncology (IO) seeks to bring non-conventional approaches into conventional oncology care in an evidence-based, coordinated manner. Little is known about the effects of such consultations on patient-reported symptoms. Methods: We reviewed data from patients referred for an IO outpatient consultation between 2009 and 2013, comparing the cohort of patients with at least one follow-up to the cohort with an initial consultation only. Assessments completed at initial and follow-up encounters included: complementary and alternative medicine (CAM) use questionnaire, Measure Yourself Concerns and Wellbeing (MYCaW), Edmonton Symptom Assessment Scale (ESAS; 10 symptoms, scale 0-10, 10 worst), and post-consultation satisfaction. ESAS individual items and global (GDS; score 0-90), physical (PHS, 0-60) and psychological (PSS, 0-20) distress scales were analyzed. Results: 642 patients out of 2,474 (26%) new patient IO consultations had at least one follow-up encounter (mean 3.2; SD 1.8). Age, place of residence, and higher satisfaction were predictors of follow-up. Statistically significant improvement in symptoms between initial consult and follow-up were observed for depression, anxiety, well-being, and subscales of GDS and PSS (all p's > 0.01). For those with moderate to severe symptoms at their initial consult (ESAS scores ≥ 4), we observed clinical response rates (improvement) of 49-75% for all ESAS symptoms at follow-up. Conclusions: Patients presenting for IO follow-up had overall mild to moderate symptoms at baseline and stable symptom burden over time. Greatest improvements were observed for psychosocial symptoms, most pronounced for the subset of patients with moderate to severe symptoms at their initial consultation.

Integrative Oncology Physician Consultations at a Comprehensive Cancer Center: Analysis of Demographic, Clinical and Patient Reported Outcomes.

Background: Integrative oncology (IO) is a relatively new field that seeks to bring evidence-based, non-conventional approaches into conventional oncology care in a coordinated and safe manner. Though complementary and alternative medicine (CAM) are highly utilized by cancer patients, little is known about the characteristics of patients seeking IO consultation. Methods: Patients presenting for an outpatient IO consultation completed a CAM use questionnaire, Measure Yourself Concerns and Wellbeing (MYCaW), Edmonton Symptom Assessment Scale (ESAS), Quality of Life Short Form 12 (SF-12), and post-consultation satisfaction item. Results: 2,474 new patient IO consultations were conducted from 9/2009 to 12/2013 and 2367 (96%) completed at least one measure. Most were female (69%); the most frequent cancer type was breast (29%); 38% had distant/advanced disease; 75% had used a CAM approach in prior 12 months. The most common concerns were seeking an integrative/holistic approach (34%), herbs/supplements (34%), and diet/nutrition (21%). Overall symptom burden was low, with baseline symptom scores (ESAS) highest (worst) for sleep (4.2; SD 2.8), fatigue (4.0; SD 2.8), and well-being (3.8; SD 2.6). On the SF-12, the physical health scores (35.3; SD 7.5) were significantly lower than that of a healthy population (50), but mental health scores were not (46.8; SD 10.2). Satisfaction was high (9.4; SD 1.3) with the consultation. Conclusions: Patients presenting for IO consultation tended to have early stage disease, had previously used a CAM approach, had a relatively low symptom burden, and were most interested in developing an integrative approach to their care or discussing herbs/supplement use.