A Feasibility Randomized Controlled Trial of Prehabilitation During Neoadjuvant Chemotherapy for Women with Breast Cancer: A Mixed Methods Study.

BACKGROUND: Limited data exist regarding the role of multimodal prehabilitation during neoadjuvant chemotherapy (NACT) for breast cancer. Determining large trial feasibility and identifying signals of prehabilitation benefit are needed. PATIENTS AND METHODS: We conducted a randomized controlled feasibility trial of multimodal prehabilitation versus usual care during NACT among women diagnosed with non-metastatic breast cancer. Intervention participants received an individualized exercise program, dietetic support, and stress management counseling during NACT. The trial assessed feasibility via rates of recruitment, attrition, adherence, and study-related adverse events. Physical fitness (Six Minute Walk Test, grip strength, anthropometrics) and patient-reported outcomes were assessed at baseline, after NACT completion, and 6 months after surgery as exploratory outcomes, and analyzed using linear mixed effects models. Qualitative data were collected from a subsample to understand feasibility and acceptability of prehabilitation. RESULTS: A total of 72 participants were enrolled from the 123 eligible patients (recruitment rate of 53%). There was a 13% attrition rate and no intervention-related adverse events. Participants in the prehabilitation group had better 6-min walk distance at the post-chemotherapy timepoint [between group difference of 49.43 m, 95% confidence interval (CI) - 118.1, 19.2] and at the post-surgery timepoint (27.3, 95% CI -96.8, 42.2) compared with the control group. Prehabilitation participants reported better quality of life, less fatigue, and improved physical activity levels compared with usual care participants. Interviews revealed that the intervention had a positive impact on the treatment experience. CONCLUSIONS: This study demonstrated feasibility and improvement in physical and psychosocial outcomes. Larger trials assessing intervention efficacy to confirm indications of prehabilitation benefit are warranted.

Neural correlates of concurrent sound perception: A review and guidelines for future research.

The perception of concurrent sound sources depends on processes (i.e., auditory scene analysis) that fuse and segregate acoustic features according to harmonic relations, temporal coherence, and binaural cues (encompass dichotic pitch, location difference, simulated echo). The object-related negativity (ORN) and P400 are electrophysiological indices of concurrent sound perception. Here, we review the different paradigms used to study concurrent sound perception and the brain responses obtained from these paradigms. Recommendations regarding the design and recording parameters of the ORN and P400 are made, and their clinical applications in assessing central auditory processing ability in different populations are discussed.

Evaluation of Usability and Satisfaction of Two Online Tools to Guide Return to Work for Cancer Survivors on the Cancer and Work Website.

Prompt services and work-focused support systems are needed to aid cancer survivors returning to work or finding work. Purpose This knowledge translation and implementation project focused on the knowledge users' experience and need for refinement of three work-focused tools to support return to work and maintain work following cancer through their participation in a hands-on workshop. The tools assessed for their utility are a Job Analysis Tool (JAT), a Return to Work (RTW) tool, and a bilingual Canadian website on Cancer and Work. Methods Four workshops took place in three Canadian cities. Participants included cancer survivors, healthcare professionals, and employer representatives. Following an overview of the website and tools, workshop participants (N = 28) completed qualitative and quantitative satisfaction and usability questionnaires using the System Usability Scale and open-ended questions. Qualitative data was analyzed using content analyses from the think-aloud data and from the four open-ended questions collected during the users' use of the tools and website. Results Overall, most study participants reported high satisfaction with the JAT and RTW tools, the Cancer and work website and the workshop. Good usability scores were reported for the RTW planner (73.65 ± 12.61) and the website (74.83 ± 12.36), and only acceptable usability scores for the JAT (68.53 ± 11.90). Conclusion Overall, the study documented the value of the tools and the website to support the RTW process as assessed by several key knowledge user groups. The JAT is considered a helpful procedure to identify job demands in order to guide job accommodations. Given participants' responses that the tool is useful, the next steps are to implement the recommendations for improvement and knowledge dissemination to increase its uptake and the use of job analysis overall.

The Development and Evaluation of a Patient Educational Resource for Cancer-Related Cognitive Dysfunction.

Cancer patients and survivors frequently experience cognitive deficits, including problems with attention and memory. These symptoms, referred to as cancer-related cognitive dysfunction (CRCD), are associated with distress. Learning about CRCD and self-management strategies may improve functioning and quality of life in cancer survivors. This study describes the development and evaluation of a CRCD resource for cancer patients. An educational booklet was developed in accordance with multiple evidence-based guidelines for cancer patient education. Cancer patients on chemotherapy (N = 113; 34% men; median age 55, range 19-85) reviewed the booklet and self-reported CRCD knowledge before and after reading the booklet. They also gave ratings on general impressions of the booklet. Seventy-five percent of participants reported that the resource increased their self-reported CRCD knowledge. A Wilcoxon signed-rank test demonstrated that exposure to the booklet elicited a statistically significant change in self-reported knowledge (Z = - 7.13, p < 0.001). A repeated-measures ANCOVA determined that the means of self-reported CRCD knowledge were significantly different between pre- and post-exposure (F(1, 92) = 7.96, p = 0.006, η2 = 0.08). Exploratory analyses revealed that self-reported CRCD knowledge increased across all educational attainment levels from pre- to post-exposure. Ninety-one percent of participants reported that all patients undergoing cancer treatment would find this booklet helpful. Cancer patients at risk for cognitive challenges gained self-reported CRCD knowledge from the booklet, and they think this knowledge would be helpful to others. A resource that makes CRCD understandable and manageable can bridge the gap in self-rated knowledge across education levels.

Cognitive rehabilitation for executive dysfunction in brain tumor patients: a pilot randomized controlled trial.

PURPOSE: Patients with brain tumors face unique quality of life challenges. Executive dysfunction is common and functionally limiting, with no established treatments as standard care. This pilot study evaluated the efficacy of Goal Management Training (GMT), a behavioral intervention combining mindfulness and strategy training, for improving executive and real-life functioning in this population. METHODS: Twenty-five primary brain tumor survivors were randomized to GMT, an active control (Brain Health Program, BHP), or a wait-list (WAIT) control group. The BHP was a supportive care intervention offering education and activities to promote general brain health, without cognitive strategy training. Participants in GMT and BHP completed eight individual sessions and homework between sessions; those in WAIT received usual care. Assessments at baseline, immediately post-training, and 4-month follow-up used a battery of objective and subjective measures, including functional goal attainment. RESULTS: Adherence (% sessions completed) was high for both GMT (98.9%) and BHP (84.4%). Executive functions improved with GMT but not BHP or WAIT (repeated measures analysis of variance, time-by-group interaction, post-training P = 0.077, follow-up P = 0.046). Both intervention groups reported fewer cognitive concerns at post-training (P = 0.049) and follow-up (P < 0.001). Functional goal attainment was greatest with GMT (post-training P = 0.027, follow-up P = 0.064). CONCLUSIONS: GMT improved executive and real-life functioning in brain tumor survivors, with gains maintained at 4-month follow-up. Clinical implementation of this adaptable program merits consideration for clinically stable patients with cognitive dysfunction. Further development and larger prospective cognitive rehabilitation trials appear warranted.

Listening under difficult conditions: An activation likelihood estimation meta-analysis.

The brain networks supporting speech identification and comprehension under difficult listening conditions are not well specified. The networks hypothesized to underlie effortful listening include regions responsible for executive control. We conducted meta-analyses of auditory neuroimaging studies to determine whether a common activation pattern of the frontal lobe supports effortful listening under different speech manipulations. Fifty-three functional neuroimaging studies investigating speech perception were divided into three independent Activation Likelihood Estimate analyses based on the type of speech manipulation paradigm used: Speech-in-noise (SIN, 16 studies, involving 224 participants); spectrally degraded speech using filtering techniques (15 studies involving 270 participants); and linguistic complexity (i.e., levels of syntactic, lexical and semantic intricacy/density, 22 studies, involving 348 participants). Meta-analysis of the SIN studies revealed higher effort was associated with activation in left inferior frontal gyrus (IFG), left inferior parietal lobule, and right insula. Studies using spectrally degraded speech demonstrated increased activation of the insula bilaterally and the left superior temporal gyrus (STG). Studies manipulating linguistic complexity showed activation in the left IFG, right middle frontal gyrus, left middle temporal gyrus and bilateral STG. Planned contrasts revealed left IFG activation in linguistic complexity studies, which differed from activation patterns observed in SIN or spectral degradation studies. Although there were no significant overlap in prefrontal activation across these three speech manipulation paradigms, SIN and spectral degradation showed overlapping regions in left and right insula. These findings provide evidence that there is regional specialization within the left IFG and differential executive networks underlie effortful listening.

Towards the validation of a new, blended theoretical model of fear of cancer recurrence.

OBJECTIVE: Fear of cancer recurrence (FCR) is defined as "fear, worry, or concern about cancer returning or progressing". To date, only the seminal model proposed by Lee-Jones and colleagues has been partially validated, so additional model testing is critical to inform intervention efforts. The purpose of this study is to examine the validity of a blended model of FCR that integrates Leventhal's Common Sense Model, Mishel's Uncertainty in Illness Theory, and cognitive theories of worry. METHODS: Participants (n = 106) were women diagnosed with stage I to III breast or gynecological cancer who were enrolled in a Randomized Controlled Trial of a group cognitive-existential intervention for FCR. We report data from standardized questionnaires (Fear of Cancer Recurrence Inventory-Severity and Triggers subscales; Illness Uncertainty Scale; perceived risk of recurrence; Intolerance of Uncertainty Scale; Why do people Worry about Health questionnaire; Reassurance-seeking Behaviors subscale of the Health Anxiety Questionnaire, and the Reassurance Questionnaire) that participants completed before randomization. Path analyses were used to test the model. RESULTS: Following the addition of four paths, the model showed an excellent fit (χ2 = 13.39, P = 0.20; comparative fit index = 0.99; root mean square error of approximation = 0.06). Triggers, perceived risk of recurrence, and illness uncertainty predicted FCR. FCR was associated with maladaptive coping. Positive beliefs about worrying and intolerance of uncertainty did not predict FCR but led to more maladaptive coping. CONCLUSIONS: These results provide support for a blended FCR model.

A brief psychoeducational intervention improves memory contentment in breast cancer survivors with cognitive concerns: results of a single-arm prospective study.

PURPOSE: One in three breast cancer survivors experiences persistent cognitive changes that can negatively impact daily functioning and quality of life. In our cancer center, the largest tertiary cancer center in Canada, patients with self-reported cancer-related cognitive dysfunction (CRCD) are offered psychoeducation intended to reduce distress about CRCD symptoms and improve everyday cognitive performance, but evidence regarding this intervention's impact is lacking. Here, we assess whether a 1-hour (h), individual psychoeducational intervention designed to promote self-management of CRCD symptoms can improve attitudes and coping with memory-related difficulties in women with breast cancer. METHODS: Breast cancer survivors with self-reported CRCD (N = 100) were assessed immediately before, immediately after, and 6 weeks following the intervention. Participants' memory contentment, knowledge of CRCD, symptom distress, and self-efficacy to cope with symptoms were measured. RESULTS: Participants showed improvements in memory contentment immediately after the intervention (Cohen's d effect size and 95% CI = 0.87 [0.58, 1.16]) and 6 weeks later (d = 0.77 [0.48, 1.05]). Significant improvements in secondary study outcomes, including knowledge of CRCD (d = 1.32 [1.01, 1.63]), symptom distress (d = - 0.82 [- 1.11, - 0.53]), and self-efficacy to cope with cognitive symptoms (d = 1.45 [1.14, 1.76]), were also observed. CONCLUSIONS: A single, 1-hour psychoeducational intervention can achieve lasting and improved adjustment to memory symptoms in breast cancer survivors with self-reported CRCD. Further investigation using a randomized controlled study design is warranted. Comparisons with previously reported psychoeducational interventions for CRCD are made, and next steps for this research are discussed.

Executive functioning impairment in women treated with chemotherapy for breast cancer: a systematic review.

PURPOSE: Women with breast cancer have reported adverse cognitive effects following chemotherapy. Evidence is mixed on whether executive functioning is particularly impaired in women treated with chemotherapy, in part due to the wide range of tasks used to measure executive processes. We performed a systematic review of the published literature to evaluate whether some subcomponents of executive functioning are more vulnerable to impairment than others among breast cancer survivors who had been treated with chemotherapy. METHODS: Studies published as of April 2017 were identified using three electronic databases (MEDLINE, PsycINFO, and Web of Science) and a manual search of relevant reference lists. The methodological quality of included studies was assessed using a checklist of predefined criteria. RESULTS: Of 1280 identified articles, a total of 41 were included for review. Study findings were categorized into three primary subdomains of executive functioning: inhibition, shifting, and updating. Although there was heterogeneity in the neuropsychological measures used to assess executive functioning, tests could be grouped into the subcomponents they assessed. Inhibition appears relatively spared from the effects of chemotherapy, whereas impairments in shifting and updating are more commonly found following chemotherapy. CONCLUSIONS: Examination of subcomponents of executive functioning is recommended to better characterize the nature of executive dysfunction in women treated with chemotherapy. Future studies should include executive functioning tasks of varying complexity, use of multiple tasks to increase reliability, and alternative indices to capture performance, such as within-person variability.

Intraindividual variability in reaction time before and after neoadjuvant chemotherapy in women diagnosed with breast cancer.

OBJECTIVE: Women treated with chemotherapy for breast cancer experience subtle cognitive deficits. Research has focused on mean performance level, yet recent work suggests that within-person variability in reaction time performance may underlie cognitive symptoms. We examined intraindividual variability (IIV) in women diagnosed with breast cancer and treated with neoadjuvant chemotherapy. METHODS: Patients (n = 28) were assessed at baseline before chemotherapy (T1), approximately 1 month after chemotherapy but prior to surgery (T2), and after surgery about 9 months post chemotherapy (T3). Healthy women of similar age and education (n = 20) were assessed at comparable time intervals. Using a standardized regression-based approach, we examined changes in mean performance level and IIV (eg, intraindividual standard deviation) on a Stroop task and self-report measures of cognitive function from T1 to T2 and T1 to T3. RESULTS: At T1, women with breast cancer were more variable than controls as task complexity increased. Change scores from T1 to T2 were similar between groups on all Stroop performance measures. From T1 to T3, controls improved more than women with breast cancer. IIV was more sensitive than mean reaction time in capturing group differences. Additional analyses showed increased cognitive symptoms reported by women with breast cancer from T1 to T3. Specifically, change in language symptoms was positively correlated with change in variability. CONCLUSIONS: Women with breast cancer declined in attention and inhibitory control relative to pretreatment performance. Future studies should include measures of variability, because they are an important sensitive indicator of change in cognitive function.

Protocol of a randomized controlled trial of the fear of recurrence therapy (FORT) intervention for women with breast or gynecological cancer.

BACKGROUND: Clinically significant levels of fear of cancer recurrence (FCR) affect up to 49% of cancer survivors and are more prevalent among women. FCR is associated with psychological distress, lower quality of life, and increased use of medical resources. Despite its prevalence, FCR is poorly addressed in clinical care. To address this problem, we first developed, and pilot tested a 6-week, 2 h, Cognitive-existential group intervention therapy that targeted FCR in survivors of breast or gynecological cancer. Following the positive outcome of the pilot, we are now testing this approach in a randomized clinical trial (RCT). Goal and hypotheses: This multicenter, prospective RCT aims to test the efficacy of the intervention. The study hypotheses are that, compared to a control group, cancer survivors participating in the intervention (1) will have less FCR, (2) will show more favorable outcomes on the following measures: cancer-specific distress, quality of life, illness uncertainty, intolerance of uncertainty, perceived risk of cancer recurrence, and coping skills. We further postulate that the between-group differences will persist three and 6 months post-intervention. METHODS: Sixteen groups of seven to nine women are being allocated to the intervention or the control group. The control group receives a 6-week, 2 h, structurally equivalent support group. We are recruiting 144 cancer survivors from four hospital sites in three Canadian cities. The sample size was based on the moderate pre/post-test changes found in our pilot study and adjusted to the drop-out rates. MEASUREMENTS: The primary outcome, FCR, is measured by the Fear of Cancer Recurrence Inventory. Secondary outcomes measured include cancer-specific distress, perceived risk of cancer recurrence, illness uncertainty, intolerance of uncertainty, coping, and quality of life. We use reliable and recognized valid scales. Participants are to complete the questionnaire package at four times: before the first group session (baseline), immediately after the sixth session, and 3 and 6 months post-intervention. ANALYSIS: In the descriptive analysis, comparison of group equivalent baseline variables, identification of confounding/intermediate variables and univariate analysis are planned. Each participant's trajectory is calculated using Generalized Estimating Equation models to determine the time and group effects, after considering the correlation structures of the groups. An intent-to-treat analysis approach may be adopted. DISCUSSION: Our Fear of Recurrence Therapy (FORT) intervention has direct implications for clinical service development to improve the quality of life for patients with breast (BC) and gynecological cancer (GC). Based on our pilot data, we are confident that the FORT intervention can guide the development of effective psychosocial cancer survivorship interventions to reduce FCR and improve psychological functioning among women with BC or GC. TRIAL REGISTRATION: Dr. Christine Maheu registered the trial with ISRCTN registry (Registration number: ISRCTN83539618, date assigned 03/09/2014).

Pretreatment Differences in Intraindividual Variability in Reaction Time between Women Diagnosed with Breast Cancer and Healthy Controls.

OBJECTIVES: Chemotherapy has adverse effects on cognitive performance in women treated for breast cancer, but less is known about the period before chemotherapy. Studies have focused on mean level of performance, yet there is increasing recognition that variability in performance within an individual is also an important behavioral indicator of cognitive functioning and underlying neural integrity. METHODS: We examined intraindividual variability (IIV) before chemotherapy and surgery in women diagnosed with breast cancer (n=31), and a healthy control group matched on age and education (n=25). IIV was calculated across trials of a computerized Stroop task, including an examination of the slowest and fastest trials of reaction time (RT) responses. RESULTS: The groups were equivalent on overall accuracy and speed, and participants in both groups were less accurate and slower on incongruent trials compared with congruent trials. However, women with breast cancer became more variable with increased task difficulty relative to healthy controls. Among the slowest RT responses, women with breast cancer were significantly more variable than healthy controls on incongruent trials. This suggests that a specific variability-producing process (e.g., attentional lapses) occurs in task conditions that require executive control (e.g., incongruent trials). CONCLUSIONS: Results are consistent with other evidence of executive dysfunction among women treated for breast cancer. These findings highlight the importance of pretreatment assessment and show that variability in performance provides information about cognition that measures of central tendency do not.

Intra-individual variability in women with breast cancer.

Studies assessing cognitive functioning in women treated for breast cancer have used primarily standardized neuropsychological tests and examined accuracy and/or reaction time as outcome measures: they have been inconsistent in identifying the cognitive domains affected and the severity of deficits. In other contexts of neural development and disorders, measures of Intra-individual variability (IIV) have proven useful in identifying subtleties in performance deficits that are not captured by measures of central tendency. This article presents proof of concept that assessing IIV may also increase understanding of the cognitive effects of cancer treatment. We analyzed mean accuracy and reaction time, as well as IIV from 65 women with breast cancer and 28 age and education matched controls who performed the Conner's Continuous Performance Test, a "Go-NoGo" task. Although there were no significant differences between groups using measures of central tendency, there was a group × inter-stimulus interval (ISI) interaction for IIV Dispersion (p < .001). Patient Dispersion was more variable at shorter ISI than controls and less variable at long ISI, suggesting greater sensitivity to presentation speed. Interpretation of IIV differences requires further investigation. Our results suggest that future studies would benefit from designs that allow analysis of IIV measures in studies assessing cognition in cancer survivors.

Cognitive Symptoms Across Diverse Cancers.

Importance: Psychosocial health services for adults with cancer should include support for cognitive symptoms and symptom clusters. Objective: To characterize the frequency and severity of cognitive symptoms and to identify demographic and clinical risk factors associated with moderate to severe cognitive symptoms among outpatient adults with cancer seeking psychosocial support. Design, Setting, and Participants: This cross-sectional study analyzed data from routine patient-reported symptom screening during clinic appointments at the Princess Margaret Cancer Centre in Toronto, Canada, between January 1, 2013, and December 31, 2019. Participants were outpatient adults (aged ≥18 years) with diverse cancer diagnoses who endorsed interest in receiving psychosocial support from a health care team member. Data analysis was performed from April 2020 to June 2024. Main Outcomes and Measures: The presence and severity of cognitive symptoms as self-rated by participants were characterized across 12 cancer types: brain or central nervous system (CNS), breast, gastrointestinal, head and neck, gynecological, thyroid, lung and bronchus, sarcoma, genitourinary, melanoma, hematological, and all other cancers. Multivariable logistic regression was used to explore the associations between demographic, clinical, and symptom factors and moderate to severe cognitive symptoms. Results: Across the sample of 5078 respondents (2820 females [55.5%]; mean [SD] age at time of survey, 56.0 [14.1] years) requesting psychosocial support, 3480 (68.5%) reported cognitive symptoms of any severity, ranging from 59.5% in sarcoma to 86.5% in brain or CNS cancer. Moderate to severe cognitive symptoms were reported by 1544 patients (30.4%), with the proportions being 51.3% for patients with brain or CNS, 37.0% for breast, 36.2% for thyroid, 30.9% for melanoma, 29.6% for head and neck, 28.3% for gastrointestinal, 28.2% for hematological, 28.1% for gynecological, 24.9% for lung and bronchus, 24.9% for sarcoma, 21.0% for genitourinary, and 26.8% for all other cancers. Across the entire sample, moderate to severe cognitive symptoms were associated with recurrence or progression involving the CNS (odds ratio [OR], 2.62; 95% CI, 1.80-3.81), depression (OR, 1.92; 95% CI, 1.59-2.31), tiredness (OR, 1.82; 95% CI, 1.52-2.19), drowsiness (OR, 1.64; 95% CI, 1.39-1.93), anxiety (OR, 1.57; 95% CI, 1.30-1.89), shortness of breath (OR, 1.38; 95% CI, 1.16-1.61), female sex (OR, 1.33; 95% CI, 1.14-1.56), first-line chemotherapy received (OR, 1.22; 95% CI, 1.05-1.41), and metastatic disease at diagnosis (OR, 0.74; 95% CI, 0.61-0.89). Within individual cancer types, tiredness and depression were consistently associated with moderate to severe cognitive symptoms. Conclusions and Relevance: This cross-sectional study found that cognitive symptoms were frequently reported by patients across a wide range of cancer types; higher severity of cognitive symptoms was consistently associated with higher symptom burden. The findings could be used to inform decision-making regarding access to cognitive screening, assessment, and supportive care in outpatient oncology clinics.

CaRE@ELLICSR: Effects of a clinically integrated, group-based, multidimensional cancer rehabilitation program.

BACKGROUND: Although oncology clinical practice guidelines recognize the need and benefits of exercise, the implementation of these services into cancer care delivery remains limited. We developed and evaluated the impact of a clinically integrated 8-week exercise and education program (CaRE@ELLICSR). METHODS: We conducted a mixed methods, prospective cohort study to examine the effects of the program. Each week, participants attended a 1-h exercise class, followed by a 1.5-h education session. Questionnaires, 6-min walk tests (6MWT), and grip strength were completed at baseline (T0), 8 weeks (T1), and 20 weeks (T2). Semi-structured interviews were conducted with a sub-sample of participants about their experience with the program. RESULTS: Between September 2017 and February 2020, 277 patients enrolled in the program and 210 consented to participate in the research study. The mean age of participants was 55 years. Participants were mostly female (78%), white/Caucasian (55%) and half had breast cancer (50%). Participants experienced statistical and clinically meaninful improvements from T0 to T1 in disability, 6MWT, grip strength, physical activity, and several cancer-related symptoms. These outcomes were maintained 3 months after program completion (T2). Qualitative interviews supported these findings and three themes emerged from the interviews: (1) empowerment and control, (2) supervision and internal program support, and (3) external program support. CONCLUSIONS: This study demonstrates the impact of overcoming common organizational barriers to deliver exercise and rehabilitation as part of routine care. CaRE@ELLICSR demonstrated clinically meaningful improvements in patient-reported and functional outcomes and was considered beneficial and important by participants for their recovery and wellbeing.

A phase 2 study of a longitudinal multidimensional rehabilitation program for allogeneic blood and marrow transplantation patients.

ABSTRACT: Allogeneic blood and marrow transplantation (alloBMT) is a curative treatment for blood cancers associated with various treatment-related adverse events and morbidities for which rehabilitation programs are currently limited. A phase 2 randomized controlled trial (RCT) was conducted to assess the feasibility, acceptability, and impact of CaRE-4-alloBMT, a longitudinal, multidimensional cancer rehabilitation program for patients undergoing alloBMT. The primary outcomes included the feasibility and acceptability of the intervention and the methods. Feasibility was assessed through recruitment, retention, and adherence rates. Acceptability was assessed through qualitative interviews. Secondary clinical outcomes were collected through questionnaires and physiological assessments at 4 time points. A total of 80 participants were recruited and randomized. Recruitment (72%) and retention (70%) rates, along with qualitative findings, support the feasibility of the intervention. Adherence was suboptimal, most notably educational module completion (22.7%). Treatment effect sizes of 0.70 (95% confidence interval [CI], 0.20-1.21; 30-second sit-to-stand test) and 0.46 (95% CI, -0.17 to 1.09; 36-Item Short Form Survey) were observed in favor of the intervention. The results appear promising; however, the findings are limited by missing data owing to attrition. Modifications will be required to refine the program and inform a phase 3 RCT. This trial was registered at www.ClinicalTrials.gov as #NCT04966156.

Helping Her Heal-Group: a pilot study to evaluate a group delivered educational intervention for male spouses of women with breast cancer.

BACKGROUND: Distress in husbands of women with early-stage breast cancer may be equivalent to or even higher than their wives. Husbands often struggle to help and support their wives cope with the illness and its treatment. In response, we developed a five-session group educational counselling intervention (Helping Her Heal-Group (HHH-G)) for husbands of women with early-stage breast cancer. The primary aim of the current pilot study was to determine the acceptability and feasibility of HHH-G and to obtain a preliminary estimate of its impact on participating men's skills, self-confidence and self care. Secondary aims were to assess the impact of the intervention on both the participating spouses' and wives' ratings of marital quality and depressed mood. METHODS: The study employed a one-arm, pre-post-intervention design whereby participating men (n=54) and their wives (n=54) independently completed measures at baseline (T0), immediately following the last session (T1) and 3 months after the last session (T2). RESULTS: Overall, there was very high study retention (87%). On the basis of the questionnaire data, we found significant improvements in spouses' self-efficacy (p<0.001) and self-reported skills including wife support (p=0.003) and self-care (p<0.001). In addition, there was a significant improvement in wives' mood scores (p=0.003). Post-intervention interviews support acceptability and impact of the HHH-G intervention, and provide support for the group format of the program. CONCLUSIONS: The feasibility and acceptability of HHH-G was supported, and treatment outcomes suggest the potential benefits of the intervention. Phase III evaluation of HHH-G program is warranted.

Neural alpha oscillations index context-driven perception of ambiguous vowel sequences.

Perception of bistable stimuli is influenced by prior context. In some cases, the interpretation matches with how the preceding stimulus was perceived; in others, it tends to be the opposite of the previous stimulus percept. We measured high-density electroencephalography (EEG) while participants were presented with a sequence of vowels that varied in formant transition, promoting the perception of one or two auditory streams followed by an ambiguous bistable sequence. For the bistable sequence, participants were more likely to report hearing the opposite percept of the one heard immediately before. This auditory contrast effect coincided with changes in alpha power localized in the left angular gyrus and left sensorimotor and right sensorimotor/supramarginal areas. The latter correlated with participants' perception. These results suggest that the contrast effect for a bistable sequence of vowels may be related to neural adaptation in posterior auditory areas, which influences participants' perceptual construal level of ambiguous stimuli.

Neurocognitive impairment, neurobehavioral symptoms, fatigue, sleep disturbance, and depressive symptoms in patients with newly diagnosed glioblastoma.

Background: In addition to poor survival rates, individuals with glioblastoma (GBM) are at risk of neurocognitive impairment due to multiple factors. This study aimed to characterize neurocognitive impairment, neurobehavioral symptoms, fatigue, sleep disturbance, and depressive symptoms in newly diagnosed GBM patients; and to examine whether neurobehavioral symptoms, fatigue, sleep, and depressive symptoms influence neurocognitive performance. Methods: This study was part of a prospective, inception cohort, single-arm exercise intervention in which GBM patients underwent a neuropsychological assessment shortly after diagnosis (median 4 weeks; ie, baseline) and 3, 6, 12, and 18 months later, or until tumor progression. Here, we present baseline data. Forty-five GBM patients (mean age = 55 years) completed objective neurocognitive tests, and self-report measures of neurobehavioral symptoms, fatigue, sleep disturbance, and depressive symptoms. Results: Compared to normative samples, GBM patients scored significantly lower on all neurocognitive tests, with 34 (76%) patients exhibiting neurocognitive impairment. Specifically, 53% exhibited impairment in memory retention, 51% in executive function, 42% in immediate recall, 41% in verbal fluency, and 24% in attention. There were high rates of clinically elevated sleep disturbance (70%), fatigue (57%), depressive symptoms (16%), and neurobehavioral symptoms (27%). A multivariate regression analysis revealed that depressive symptoms are significantly associated with neurocognitive impairment. Conclusions: GBM patients are vulnerable to adverse outcomes including neurocognitive impairment, neurobehavioral symptoms, fatigue, sleep disturbance, and depressive symptoms shortly after diagnosis, prior to completing chemoradiation. Those with increased depressive symptoms are more likely to demonstrate neurocognitive impairment, highlighting the need for early identification and treatment of depression in this population.

A longitudinal multidimensional rehabilitation program for patients undergoing allogeneic blood and marrow transplantation (CaRE-4-alloBMT): Protocol for a phase II feasibility pilot randomized controlled trial.

BACKGROUND: Allogeneic blood and marrow transplantation (alloBMT) is a curative treatment for blood cancers associated with various treatment-related adverse events and morbidities. Current rehabilitation programs are limited for patients undergoing alloBMT and research is urgently needed to test the acceptability and effectiveness of these programs. In response, we developed a 6-month multidimensional longitudinal rehabilitation program that spans from pre transplant to 3 months post transplant discharge (CaRE-4-alloBMT). METHODS: This study is a phase II randomized controlled trial (RCT) conducted at the Princess Margaret Cancer Centre in patients undergoing alloBMT. A total of 80 patients stratified by frailty score will be randomized to receive usual care (n = 40) or CaRE-4-alloBMT plus usual care (n = 40). The CaRE-4-alloBMT program includes individualized exercise prescriptions, access to online education through a dedicated self-management platform, wearable technology for remote monitoring, and remote tailored clinical support. Feasibility will be assessed by examining the recruitment and retention rates and adherence to the intervention. Safety events will be monitored. Acceptability of the intervention will be assessed through qualitative interviews. Secondary clinical outcomes will be collected through questionnaires and physiological assessments at baseline (T0, 2-6 weeks pre-transplant), transplant hospital admission (T1), hospital discharge (T2), and 3 months post-discharge (T3). CONCLUSION: This pilot RCT study will determine the feasibility and acceptability of the intervention and study design and will inform full-scale RCT planning.