This controlled comparison study evaluated objective and subjective cognitive function and their relationships with patient-reported symptoms (depression, fatigue, insomnia) in patients receiving tyrosine kinase inhibitors (TKIs) for chronic myeloid leukemia (CML) and non-cancer controls. Patients with CML in chronic phase treated with the same oral TKI for >= 6 months (n = 90) and non-cancer controls (n = 87) completed a neurocognitive battery and self-report measures. Patients demonstrated worse overall neuropsychological performance (p = .05) and verbal memory (p = .02) compared to controls. Patients were not more likely to meet criteria for impaired cognitive performance compared to controls (ps>.26). Patients reported worse subjective global and domain-specific cognitive complaints and less satisfaction with cognitive function compared to controls (ps < .05). Patients also reported greater fatigue and insomnia symptoms (ps < .001). In both groups, greater fatigue, insomnia, and depressive symptoms were associated with worse subjective cognition (ps < .01). Longitudinal studies are needed to examine changes in cognitive function in patients before and during TKI treatment.

The success of chimeric antigen receptor (CAR) T cell therapy in treating patients with relapsed/refractory hematologic malignancies is leading to a growing number of survivors treated with this regimen. To our knowledge, no previous studies have examined neurocognitive performance in adult CAR T cell therapy recipients, despite high rates of neurotoxicity and cytokine release syndrome (CRS) in the acute treatment period. This study examined changes in neurocognitive performance in the first year after CAR T cell therapy for non-Hodgkin lymphoma (NHL). Putative risk factors for worsening neurocognitive performance (eg, neurotoxicity, CRS) were explored as well. Neurocognition was assessed before initiation of CAR T cell therapy and at 30, 90, and 360 days post-treatment. Clinical variables were abstracted from medical records. Mixed models were used to examine change in total neurocognitive performance (TNP) and cognitive domains (ie, attention, executive function, verbal ability, immediate and delayed memory, and visuospatial abilities). Among 117 participants (mean age, 61 years; 62% male), TNP and executive function declined slightly on average from baseline to day 90 and then improved from day 90 to day 360 (P <.04). Small but significant linear declines in visuospatial ability on average were also observed over time (P =.03). Patients who had 4 or more lines of previous therapy and those with worse neurotoxicity (but not CRS) demonstrated worse TNP. CAR T cell therapy recipients reported transient or persistent deterioration in several cognitive domains, although changes were slight. These findings may be useful when educating future patients on what to expect when receiving CAR T cell therapy. (c) 2022 The American Society for Transplantation and Cellular Therapy. Published by Elsevier Inc. All rights

Background Cognitive behavioral therapy for targeted-therapy related fatigue (CBT-TTF) has demonstrated preliminary efficacy in reducing fatigue in patients treated with tyrosine kinase inhibitors (TKIs) for chronic myeloid leukemia (CML). Purpose The aim of the current analyses was to explore whether fatigue perpetuating factors (disturbed sleep/wake cycle, dysregulated activity patterns, maladaptive cognitions about fatigue and cancer, insufficient processing of cancer and treatment, inadequate social support and interactions, heightened fear of cancer progression) changed over time in patients receiving CBT-TTF, and whether the effect of CBT-TTF on fatigue was mediated by these factors. Methods Secondary data analyses were conducted from a pilot randomized controlled trial. Patients with CML treated with a TKI who reported moderate to severe fatigue were randomized 2:1 to CBT-TTF delivered via FaceTime for iPad or a waitlist control condition (WLC). Self-report measures of fatigue and fatigue perpetuating factors were obtained before randomization and post-intervention (i.e., approximately 18 weeks later). Mixed model and mediation analyses using bootstrap methods were used. Results A total of 36 participants (CBT-TTF n = 22, WLC n = 14) who had baseline and 18-week follow-up data and attended >5 sessions for CBT-TTF were included. Participants randomized to CBT-TTF reported improvements in activity (mental, physical, social, p’s ≤ .023) and cognitions (helplessness, catastrophizing, focusing on symptoms, self-efficacy, p’s ≤ .003) compared to WLC. Mental activity, social activity, self-efficacy, helplessness, and focusing on symptoms, as well as sleep and insufficient processing (avoidance) mediated the relationship between treatment group and fatigue. Conclusions CBT-TTF appears to improve TKI-related fatigue in CML patients through changes in behavior (sleep, activity patterns) and cognitions about fatigue and cancer. A larger randomized controlled trial is warranted to confirm these findings.

OBJECTIVE:Patients with gynecologic malignancies commonly experience distressing symptoms during chemotherapy. This study sought to evaluate whether symptoms accumulated over the course of several chemotherapy cycles, which could provide essential information for planning supportive interventions.METHOD:Patients with gynecologic malignancies completed questionnaires about fatigue, depressive symptoms, sleep, and physical activity 1 week before and after chemotherapy cycles 1, 3, and 6. Multilevel models examined the effects of time (pre- and postchemotherapy), treatment cycle (1, 3, 6), and their interaction on symptoms. Logistic regression models examined the effects of time, treatment cycle, and their interaction on the proportion of participants exceeding thresholds for clinically meaningful symptomatology.RESULTS:Most participants (N = 140; Mage = 60.8 years, SD = 10.4) had ovarian cancer (49%) and Stage III disease (55%). Participants reported worse fatigue, depressive symptoms, sleep disturbance, and sleep efficiency from pre- to posttreatment at each cycle (ps < .001). With each successive cycle, participants reported worse pretreatment fatigue (p < .001) and depressive symptoms (p < .01) but better sleep efficiency (p = .02). Fatigue increases attenuated across cycles (p = .04). There were no changes in physical activity. Across time points, at least half of participants met clinical thresholds for fatigue, sleep disturbance, and low sleep efficiency and were minimally physically active. Postchemotherapy cycle 6, 23% of participants reported clinically meaningful depressive symptoms.CONCLUSIONS:Patients with gynecologic malignancies have high rates of clinically meaningful symptomatology during chemotherapy. Patients may experience a cumulative burden of symptomatology as treatment progresses, which could have therapeutic implications. Early implementation of supportive interventions should be considered to prevent or mitigate cumulative treatment burden. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Cognitive-Behavioral Therapy for Insomnia (CBT-I) is the gold-standard treatment for insomnia, which is common among breast cancer survivors (BCS). This pilot randomized controlled trial tested the first CBT-I intervention for Spanish-speaking BCS delivered using eHealth. Participants (N = 30) were Spanish-speaking BCS with insomnia symptoms recruited in Puerto Rico and randomized to a 6-week eHealth CBT-I group intervention or a waitlist control. Primary outcomes were acceptability (recruitment, treatment satisfaction) and feasibility (retention, attendance). Secondary outcomes were group differences in sleep outcomes post-treatment (i.e., insomnia symptoms, sleep disturbance, sleep efficiency). Recruitment (95%) and retention (97%) were excellent. All CBT-I participants (100%) attended ≥ 3 of 6 sessions. Satisfaction with CBT-I was acceptable. Post-intervention, there were medium to large group differences for average insomnia symptoms (d = 1.02), sleep disturbance (d = 1.25), and sleep efficiency (d = 0.77) favoring CBT-I. There were small/medium to medium/large group differences for the proportion of participants with clinically significant insomnia symptoms (d = 0.52), sleep disturbance (d = 0.67), and low sleep efficiency (d = 0.33) favoring CBT-I. Spanish-language eHealth CBT-I for BCS was acceptable and feasible and showed preliminary efficacy. ClinicalTrials.gov TRN: NCT04101526 (Posted September 24, 2019).

Background Trials of immune checkpoint inhibitors (ICIs) have published patient-reported quality of life (QOL), but the size and heterogeneity of this literature can make patient education difficult. This meta-analysis aimed to describe change in QOL and symptomatology in patients receiving ICIs for cancer. Methods Following Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines, databases were searched through November 2019 for articles or abstracts of prospective, original studies reporting longitudinal QOL in adult cancer patients treated with ICIs. The prespecified primary outcomes were change in global QOL among patients treated with ICIs and difference in change since baseline in global QOL between patients treated with ICI vs non-ICI active treatment. Secondary outcomes included physical functioning and symptomatology. All statistical tests were 2-sided. Results Of 20 323 publications, 26 met inclusion criteria. Global QOL did not change over time in patients treated with ICIs (k = 26, n = 6974; P = .19). Larger improvements in global QOL was observed in patients receiving ICI vs non-ICI regimens (k = 16, ICI: n = 3588; non-ICI: n = 2948; P < .001). Physical functioning did not change in patients treated with ICIs (k = 14, n = 3169; P = .47); there were no differences in mean change between ICI vs non-ICI regimens (k = 11, n = 4630; P = .94). Regarding symptoms, appetite loss, insomnia, and pain severity decreased, but dyspnea severity increased in patients treated with ICIs (k = 14, n = 3243-3499; P < .001). Insomnia severity was higher in patients treated with ICIs than non-ICI regimens (k = 11, n = 4791; P < .001). Conclusions This study is among the first to quantitatively summarize QOL in patients treated with ICIs. Findings suggest ICI recipients report no change in global QOL and higher QOL than patients treated with non-ICI regimens.

Tyrosine kinase inhibitors (TKIs) substantially improve survival for patients with chronic myeloid leukemia (CML), but fatigue associated with TKIs can negatively impact patients’ quality of life and adherence. This study sought to identify correlates of fatigue (e.g., sociodemographic characteristics, clinical characteristics, health behaviors) among patients with CML taking TKIs who reported moderate to severe fatigue. Adults with CML experiencing at least moderate fatigue were recruited for a pilot trial of a cognitive behavioral intervention to improve fatigue. Data collected pre-intervention were used to explore concurrent correlates of fatigue in univariate and multivariable models. Participants (N = 44, 48% female) were M = 55.6 years old (SD = 12.6) and had been diagnosed with CML M = 5.2 years prior (SD = 5.3). Participants had been taking their current TKI for M = 2.5 years (SD = 2.7). Most participants (64%) had previously been treated with ≥ 1 other TKI. More than three-quarters of participants (77%) reported severe fatigue. In univariate models, worse fatigue was associated with higher BMI (r = -0.36, p = 0.018), prior treatment with other TKI(s) (r =  − 0.34, p = 0.024), worse sleep disturbance (r =  − 0.51, p < 0.001), and less physical activity (r = 0.31, p = 0.043). In a multivariable model, significant univariate correlates accounted for 39% of the variance in fatigue. Worse fatigue remained significantly correlated with higher BMI (β =  − 0.33, p = 0.009) and more disturbed sleep (β =  − 0.45, p < 0.001). Results may inform future research aiming to identify fatigued patients with CML at risk for experiencing more severe fatigue during TKI therapy. Identifying predictors of fatigue severity could aid clinicians in identifying which patients will benefit from referrals to supportive therapy. Trial registration: NCT02592447, October 30, 2015

Background Androgen deprivation therapy (ADT) may affect cognitive function in men with prostate cancer (PCa). This study examined whether insomnia symptoms mediate the relationship between ADT and perceived cognitive function and whether depressive symptoms, fatigue severity, and physical activity moderate the strength of this relationship. Methods This was a prospective study of ADT recipients (n = 83) who were matched with control patients with PCa who were not on ADT (n = 92) and with controls with no history of cancer (n = 112) over a 2-year follow-up period. Perceived cognitive function and satisfaction were assessed with the Everyday Cognition Scale. Insomnia was assessed with the Insomnia Severity Index. Multilevel mediation analyses were conducted to estimate the indirect effect of ADT on perceived cognitive function through insomnia symptoms. Exploratory moderated mediation analyses assessed whether the indirect effect of ADT on perceived cognitive function through insomnia symptoms was dependent on levels of fatigue, depression, or physical activity. Results Insomnia symptoms significantly mediated the relationship between receipt of ADT and perceived cognitive function (P < .001) and satisfaction with cognition (P < .001) after controlling for comorbidities. Men with greater fatigue had a more pronounced association of ADT with insomnia severity. Men with greater depressive symptoms had a stronger association between insomnia severity and worse perceived cognitive function. Physical activity was not a significant moderator of the relationship between ADT and perceived cognitive function. Conclusions Insomnia influenced the relationship between ADT and perceived cognitive abilities. Interventions to address insomnia, fatigue, and depression may improve perceived cognitive function.

Immune checkpoint inhibitors (ICIs) are increasingly used for advanced lung cancer, but few studies have reported on patient-reported outcomes (PROs) outside the context of a clinical trial. The goal of the current study was to assess PROs in participants of a lung cancer registry who had been treated with an ICI. Patients participating in the GO2 Foundation’s Lung Cancer Registry who reported receiving atezolizumab, durvalumab, nivolumab, or pembrolizumab were invited to participate in a survey about their experiences during treatment. Quality of life was evaluated using the Functional Assessment of Cancer Therapy–General (FACT-G). Common symptomatic adverse events were evaluated using an item bank generated for ICIs. Internationally, 226 patients (mean age 61, 75% female) participated. Patients reported worse quality of life at the time of assessment than U.S. population and cancer normative samples. The most common moderate to severe adverse events during ICI treatment were fatigue (41%), aching joints (27%), and aching muscles (20%). Due to toxicity, 25% reported a treatment delay, 11% an emergency room visit, and 9% a hospitalization. This study is among the first to our knowledge to report on PROs of ICIs outside the context of a clinical trial. Results suggest higher rates of adverse events than previously reported in clinical trials.

Introduction: Chimeric antigen receptor (CAR) T-cell therapy can lead to durable responses in patients with relapsed/refractory hematologic malignancies. Immune effector cell-associated neurotoxicity syndrome (ICANS) occurs in up to 64% of patients. There is concern that ICANS places patients at risk for longer-term cognitive impairment. This study examined changes in patients' perceived cognition from prior to CAR T-cell therapy to days 90 and 360 in patients diagnosed with non-Hodgkins lymphoma, as well as CAR T-cell therapy-specific risk factors (e.g., ICANS, cytokine release syndrome [CRS]) and non-specific risk factors (e.g., age, education) associated with changes in cognition.

PURPOSE:Sleep disturbance may be an overlooked modifiable risk factor for health disparities among African-American breast cancer survivors (AABCS). This study aimed to identify the prevalence of and risk factors for sleep disturbance in a cohort of AABCS.METHODS:The study was conducted among participants in the Women's Circle of Health Follow-up Study, a longitudinal study of breast cancer in 10 counties in New Jersey. Cases were identified shortly after diagnosis by the New Jersey State Cancer Registry. Self-reported sleep disturbance (Pittsburgh Sleep Quality Index) and other factors (e.g., socioeconomic status, menopausal status) were assessed at pre-diagnosis (n = 637), 10 months post-diagnosis (n = 261), and 24 months post-diagnosis (n = 632). Clinical data were obtained via medical record abstraction, and height and weight were measured by study staff.RESULTS:Most AABCS (57%) reported clinically significant sleep disturbance before diagnosis, and this rate remained largely unchanged at 10 months (53%) and 24 months post-diagnosis (61%). Average sleep disturbance scores indicated clinically significant disturbance at all three assessments (M range = 6.67-7.57). Most reported sleeping fewer than the recommended 7 hours per night at each assessment (range 57-65%). Risk factors for sleep disturbance were identified at each assessment, including pre-diagnosis (less education), 10 months post-diagnosis (lack of insurance, treatment with chemotherapy), and 24 months post-diagnosis (younger age, less education, lower income, obesity, and lymphedema). Treatment with endocrine therapy was a protective factor at 10 months post-diagnosis.CONCLUSION:Most AABCS report clinically significant sleep disturbance from before diagnosis through 24 months post-diagnosis. These rates appear indicate AABCS experience significant sleep-related disparities.

Abstract Cancer and its treatment can induce accelerated aging changes in physiological and behavioral processes. In studies of cancer associated cognitive decline, subjective reports of cognitive impairment are often many times greater than performance deficits on objective tests of neurocognitive functioning. In an Ecological Momentary Assessment study of 47 breast cancer patients (M age = 53.3 years), subjective ratings of cognitive performance and the occurrence of memory lapses assessed at the end of day were predicted by cognitive performance and ratings of fatigue and depressed mood throughout the day. Results indicated that poorer subjective cognition was significantly associated with elevated fatigue throughout the day. Slower processing speed, elevated ratings of fatigue, and depressed mood throughout the day were associated with a greater likelihood of memory lapses. Subjective ratings of cognitive deficits are related to objective performance, as well as common quality of life decrements among cancer survivors.

OBJECTIVE:Cancer and its treatment are associated with long-term cognitive deficits. However, most studies of cancer patients have used traditional, office-based cognitive evaluations instead of assessing patients in their daily lives. Recent research in cognitive aging suggests that variability in performance may be a sensitive indicator of cognitive decline. Using ecological momentary assessment (EMA), we examined cognitive variability among breast cancer survivors and evaluated whether ratings of fatigue and depressed mood were associated with cognition.METHODS:Participants were 47 women (M age = 53.3 years) who completed treatment for early stage breast cancer 6 to 36 months previously. Smartphones were preloaded with cognitive tests measuring processing speed, executive functioning, and memory, as well as rating scales for fatigue and depressed mood. Participants were prompted five times per day over a 14-day period to complete EMA cognitive tasks and fatigue and depressed mood ratings.RESULTS:Cognitive variability was observed across all three EMA cognitive tasks. Processing speed responses were slower at times that women rated themselves as more fatigued than their average (P < .001). Ratings of depressed mood were not associated with cognition.CONCLUSIONS:This study is the first to report cognitive variability in the daily lives of women treated for breast cancer. Performance was worse on a measure of processing speed at times when a woman rated her fatigue as greater than her own average. The ability to identify moments when cognition is most vulnerable may allow for personalized interventions to be applied at times when they are most needed.

93 Background: There is increasing clinical and research interest in patient-reported outcomes (PROs) which provide unique and complementary information to provider-rated adverse events. While several studies have been published of PROs in lung cancer patients receiving immune checkpoint blockade, to our knowledge all have focused on PROs collected as part of a clinical trial. This interim analysis describes PROs outside the context of a clinical trial. Methods: The Addario Lung Cancer Foundation (ALCF) international patient registry was used to collect patient-reported clinical and PRO information. Patients who reported current or past treatment with an FDA-approved immune checkpoint inhibitor were asked to complete a second survey of symptomatic toxicities of these therapies. Patients rated 40 symptoms on a five-point scale. The Charlson Comorbidity Index and Functional Assessment of Cancer Therapy General (FACT-G) were administered to assess comorbidities and quality of life, respectively. Results: A total of 116 patients (mean age 61, 75% female) who reported treatment with nivolumab (52%) or pembrolizumab (47%) were included in analyses. The majority of patients (70%) had been treated for 6 months or less. The most commonly reported symptoms were fatigue (72%), aching joints (52%), aching muscles (35%), insomnia (34%), back pain (30%), itching (27%), bone pain (26%), and skin dryness (25%). A total of 26% of patients had experienced a treatment delay, 10% had been to the emergency room, and 6% had been hospitalized due to toxicity. Participants reported a mean score of 75.88 (SD=17.59) on the FACT-G, significantly lower than previously-published normative data for cancer patients. Conclusions: This study is among the first to evaluate patient-reported toxicities of immune checkpoint inhibitor outside the context of a clinical trial. Results from this interim analysis indicate patient reported toxicities of immune checkpoint inhibitors are common in lung cancer patients. Additional research is needed to better understand the longitudinal course of symptomatic toxicities. Acknowledgements: ALCF, IASLC, American Lung Association.

Abstract Immune checkpoint inhibitors (ICIs) have generated significant excitement for their ability to extend survival in patients with lung, head and neck, and other cancers. In older adults with cancer, emerging research suggests that ICIs improve overall and progression-free survival, but few studies have reported on quality of life (QOL). The goal of this study was to examine changes in QOL over time in older (65+ years) vs. younger (<65 years) lung and head and neck cancer patients. Eligible participants scheduled to begin ICI for lung or head and neck cancer completed the Functional Assessment of Cancer Therapy General (FACT-G) every 2-4 weeks until disease progression. Controlling for cancer site, age group differences in QOL over time were evaluated using linear mixed models. A total of 80 lung cancer (mean age=66.5, 55% female, 55% aged 65+) and 55 head and neck cancer patients (mean age=61.5, 15% female, 45% aged 65+) provided consent. At baseline, patients with head and neck cancer reported significantly lower overall QOL, physical well-being, and emotional well-being compared to patients with lung cancer (ps<.0001). Older patients had marginally higher baseline emotional well-being than younger patients (p=.07). Across groups, there were increases in social well-being (p=.04) and a trend toward decreasing physical well-being (p=.10) over time. Patients with head and neck cancer reported lower emotional well-being over time than patients with lung cancer (p<.01). There were no age differences in QOL over time. Larger longitudinal studies are needed to better understand QOL in older patients receiving ICIs.

According to the World Health Organization over the next 20 years new cases of cancer will increase by 70%. Because of increased cancer risk with age and improved survival rates, individuals over age 65 make up 2/3 of cancer survivors. Memory and attention difficulties (e.g., ‘chemobrain’) and fatigue are common quality of life concerns for survivors but little is known regarding prevalence of these problems in daily life. Breast cancer survivors (n=38, age: 40–64), 6–36 months post-chemotherapy, were recruited from a cancer center in the United States. Neuropsychological tests were administered during a lab visit. Participants carried study smartphones for 14 days; five times daily the phones prompted them to complete brief surveys and to play brain games. Each night, participants reported on that day’s memory problems. Survivors completed 91% of smartphone cognitive tasks and 92% of daily memory failure surveys. Multilevel models were conducted to determine if survivors report more daily fatigue on days when memory failures were reported. Results indicated that differences between people accounted for 69% of the variation in daily fatigue. Contrary to predictions, survivors did not report more fatigue on days when memory failures were reported. However, survivors who reported more memory failures across the two weeks also reported higher levels of daily fatigue. In sum, ecological cognitive assessments can inform which and when survivors are affected and which domains are impacted, essential information for developing interventions targeted to survivors most impacted by decreased quality of life and situations in which they are most at-risk.