Novotny, Paul J.

LBA12004 Background: Hot flashes are among the most common adverse events impacting quality of life reported by patients receiving androgen deprivation therapy (ADT) for the treatment of prostate cancer. Oxybutynin is an effective therapy for reducing frequency and severity of hot flashes in women. Pilot information supports that this drug may also benefit men with hot flashes related to ADT. Methods: Patients with prostate cancer receiving a stable regimen of ADT with at least 28 hot flashes per week were randomized to receive either oral oxybutynin 2.5 mg twice a day, oxybutynin 5 mg twice a day, or matching placebo doses for 6 weeks. The primary endpoint was the change in patient-reported hot flash scores (determined by multiplying the number of hot flashes by the mean hot flash severity [grade 0: none, 1: mild, 2: moderate, 3: severe, and 4: very severe]) from baseline to 6 weeks, as measured by a daily hot flash diary. A total of 87 patients provided 76% power to reject the null hypothesis of no between-arm mean difference in hot flash score reduction from baseline to 6 weeks, when comparing each oxybutynin arm to the combined placebo arms. This was based on a two-sided contrast estimated from a generalized linear mixed model, α= 0.10, intraclass correlation of 0.50, population standardized mean difference of 0.50, and 10% missing data rate. Results: 88 patients were accrued between 10/28/21 and 12/02/23. Six patients cancelled before starting treatment and one was ineligible, leaving 81 analyzed patients with a median age of 68. Baseline characteristics were balanced between arms with patients reporting an average of 10.15 (SD = 5.55) hot flashes per day and an average daily hot flash score of 18.23 (SD = 13.48) at enrollment. On average, patients on the placebo arm, low dose oxybutynin arm, and high dose oxybutynin arm had reductions of 2.15, 4.77, and 6.89 hot flashes/day, respectively. Compared to placebo arm patients, high dose oxybutynin arm patients had a greater reduction in hot flashes/day (p < 0.001), as did low dose oxybutynin arm patients (p = 0.02). Daily hot flash scores for the same three protocol arms reduced by an average of 4.85, 9.94, and 13.95 points, respectively. Compared to placebo arm patients, high dose oxybutynin arm patients had a greater reduction in daily hot flash scores (p = 0.002), as did low dose oxybutynin arm patients (p = 0.07). No treatment-related grade 3+ adverse events occurred. The most commonly reported oxybutynin-related grade 2 adverse event was dry mouth. Conclusions: Oxybutynin is superior to a placebo for the management of hot flashes in men associated with androgen deprivation therapy and appears to be well tolerated. Support: UG1CA189823; https://acknowledgments.alliancefound.org . Clinical trial information: NCT04600336 .

Introduction: Immigrants to the United States often experience structural barriers to healthy nutrition and physical activity, which increases their risk of developing obesity, cardiovascular disease (CVD), and other chronic conditions. In our prior work with immigrant communities to co-develop interventions to improve nutrition and physical activity, mood was identified as a possible mediating factor. Hypothesis: We hypothesized that self-reported negative mood would be associated with unhealthy lifestyle behaviors such as poor nutrition and less physical activity. We also evaluated the relationship between mood and sociobehavioral factors such as social support and community belongingness. Methods: The Healthy Immigrant Community (HIC) study, set in Rochester, Minnesota and embedded with the Rochester Healthy Community Partnership, is a randomized, waitlist-controlled obesity and CVD risk reduction intervention. Community-based mentoring and education for health behaviors are delivered by trained health promoters, who are members of the immigrant populations, to their social networks. Baseline self-reported and biometric measures assessed nutrition, physical activity, self-efficacy, and sociobehavioral effects on healthy lifestyle behaviors. On a single-item rating of mood over the past 7 days, responses of poor or fair were considered “negative”, while good, very good, or excellent were considered “positive”. Results: The HIC study enrolled 475 adult participants; 268 Hispanic/Latino and 181 Somali participants completed baseline measures and were included in this analysis. Of the 449 participants, 107 (24%) reported “negative” mood. This group was more likely to be Hispanic/Latino (74%), female (68%), uninsured in the past 12 months (46%), or younger age (mean = 41 years; range = 18-79). Participants who endorsed negative mood at baseline had lower healthy nutrition scores ( p =0.02), lower physical activity scores ( p =0.03), and less confidence in eating healthily ( p =0.001). Those reporting negative mood also reported less support from family and friends to eat healthy ( p =<0.001) and be physically active ( p =0.01), accessed community resources for healthy eating ( p =0.001) and physical activity ( p =<0.01) less often, and reported less sense of belonging to their community ( p =0.01) than those with positive mood. Conclusion: Negative mood was significantly associated with eating a less healthy diet and being sedentary, lower confidence in maintaining a healthy diet, less perceived social support for healthy behaviors, and less sense of belonging to the community among Hispanic/Latino and Somali immigrants. Behavioral interventions designed to support a healthy lifestyle may benefit from incorporating culturally-aligned mood management and sociobehavioral strategies to reduce CVD risk and promote health equity in immigrant populations.

Abstract Background Immigrants to the United States, on average, accumulate cardiovascular risk after resettlement, including obesity. There is a need to co-create interventions to address these disparities, and mood may be an important mediating factor.Methods The Healthy Immigrant Community (HIC) study, set in southeast Minnesota, enrolled 475 adult participants in a weight loss intervention to reduce cardiovascular risk. Baseline questionnaires assessed mood, nutrition, physical activity, self-efficacy for healthy eating and physical activity, social support, and cohesion. A single-item mood rating of poor or fair was considered “negative”, while ratings of good, very good, or excellent were considered “positive”.Results A total of 449 HIC participants (268 Hispanic/Latino and 181 Somali) with complete baseline measures and were included in this analysis. Participants endorsing negative mood compared to those endorsing positive mood had lower scores for healthy eating (p = 0.02) and physical activity levels (p = 0.03), lower confidence in eating a healthy diet (p = 0.001), and felt less of a sense of belonging to their community (p = 0.01). Those endorsing negative mood also reported receiving less social support from their family and friends to eat healthy (p = < 0.001) and be physically active (p = 0.01), and less often accessed community resources for healthy eating (p = 0.001) and physical activity (p = < 0.01) compared to participants reporting positive mood.Conclusions Negative mood was associated with less healthy nutrition, lower confidence in eating healthy, sedentary lifestyle, and perceived lack of belonging to the community. Integrating mood management and self-efficacy strategies may enhance the effectiveness of lifestyle interventions among immigrants who report negative mood.ClinicalTrials.gov registration: NCT05136339; April 23, 2022

Few proton magnetic resonance spectroscopy studies have explored chemotherapy-related biochemical changes in brain regions. This observational study aimed to longitudinally assess short-term cognitive changes and brain metabolite concentrations in women undergoing chemotherapy for breast cancer. We analyzed 11 women with newly diagnosed stage 1 to 3 breast cancer. Patients were evaluated via objective cognitive testing, and patient self-report tests. Patients were examined using single voxel proton magnetic resonance spectroscopy in the medial frontal cortex, posterior cingulate gyrus, and left thalamus at baseline and after the completion of chemotherapy on a 1.5 Tesla scanner. At the posttreatment evaluation as compared to baseline, 7 of the 10 (70%) patients reported worsening memory on the MD Anderson symptom inventory (annualized change = 1.82 ± 2.88, P = .08), while the delayed recall raw score of the Rey Osterrieth complex figure test did not change from pre- to post-chemotherapy (mean annualized change = 5.00 ± 14.38, P = .30). The annualized change in the creatine concentration in the posterior cingulate gyrus was statistically significant. The annualized change in the MD Anderson symptom inventory was negatively correlated with the annualized change in the medial frontal N-acetylaspartate (Spearman correlation coefficient [rho] = −0.78, P = .01) and positively correlated with the annualized change in the posterior cingulate gyrus creatine (rho = 0.66, P = .04). Annualized changes in the Rey Osterrieth complex figure test were positively correlated with annualized changes in choline (rho = 0.83, P = .01) in the medial frontal cortex, choline (rho = 0.76, P = .04) in the left thalamus, and creatine (rho = 0.73, P = .02) in the medial frontal cortex. Our data suggest that chemotherapy may lead to the worsening of self-reported memory function, which is associated with alterations in brain metabolites.

Background Previous studies have established that higher baseline quality of life (QOL) scores are associated with improved survival in patients with metastatic colorectal cancer (mCRC). We examined the relationship between overall survival (OS) and baseline QOL. Patients and Methods A total of 1 247 patients with mCRC participating in N9741 (comparing bolus 5-FU/LV, irinotecan [IFL] vs infusional 5-FU/leucovorin [LV]/oxaliplatin [FOLFOX] vs. irinotecan/oxaliplatin [IROX]) provided data at baseline on overall QOL using a single-item linear analogue self-assessment (LASA) 0–100 point scale. The association of OS according to clinically deficient (defined as CD-QOL, score 0–50) vs not clinically deficient (nCD-QOL, score 51–100) baseline QOL scores was tested. A multivariable analysis using Cox proportional hazards modeling was performed to adjust for the effects of multiple baseline factors. An exploratory analysis was performed evaluating OS according to baseline QOL status among patients who did or did not receive second-line therapy. Results Baseline QOL was a strong predictor of OS for the whole cohort (CD-QOL vs nCD-QOL: 11.2 months vs 18.4 months, P < .0001), and in each arm IFL 12.4 vs 15.1 months, FOLFOX 11.1 months vs 20.6 months, and IROX 8.9 months vs 18.1 months. Baseline QOL was associated with baseline performance status (PS) ( P < .0001). After adjusting for PS and treatment arm, baseline QOL was still associated with OS ( P = .017). Conclusions Baseline QOL is an independent prognostic factor for OS in patients with mCRC. The demonstration that patient-assessed QOL and PS are independent prognostic indicators suggests that these assessments provide important complementary prognostic information.

12114 Background: A retrospective study suggested a potential benefit from rose geranium in sesame oil nasal spray for alleviating nasal vestibulitis symptoms in patients (pts) undergoing chemotherapy. Methods: Pts undergoing active chemotherapy who reported moderate or worse nasal symptoms were randomized 1:1 to receive a rose geranium in sesame oil nasal spray (RG) or an isotonic saline nasal spray (IS), administered twice daily for two weeks. Consenting pts completed nasal symptom questionnaires at baseline and then weekly while on treatment. The number and percentage of pts experiencing improvements in their nasal symptoms 2 weeks after initiating the nasal spray, defined as symptoms moderately (2) or very much (3) better on a 7-point global impression of change score (ranging from scores of -3: very much worse, to 3: very much better), was estimated within and then between each randomized arm, using Fisher’s exact test (5% significance level). The estimated odds ratio was determined (95% confidence interval). After 2 weeks, pts initially randomized to IS were allowed to cross-over to RG and completed weekly surveys. Results: 106 pts consented to this study; 43 pts in the RG arm and 41 in the IS arm were evaluable for the primary endpoint. Pts had a mean age of 57.8 (SD 13.9). Demographic characteristics and baseline nasal symptoms were similar between arms. The most prominent baseline nasal symptoms were dryness (36%) and bleeding (35%). Of the 43 evaluable pts who received RG, 67.4% reported improved nasal symptoms, compared with 36.6% of the 41 pts who received IS (p=0.009; Table). On the global impression of change score, pts who received RG had a mean score of 1.93 (SD 1.16), compared to a mean score of 0.98 (SD 1.41) among pts who received IS. Adjusting for potential confounding factors, pts who received RG had a 4.56 odds of responding to the nasal spray, compared with those who received IS (p=0.005). There were no significant differences between pt responses based upon type of nasal symptoms, age, allergies, or gender. Adverse events were sparse and did not differ between arms. 34 pts crossed over to RG after week 2. Among the 29 pts who completed final surveys, 37% reported a response on IS, 79% reported a response on RG. Conclusions: Rose geranium in sesame oil nasal spray significantly improves nasal vestibulitis symptoms among patients undergoing chemotherapy. Clinical trial information: NCT04620369 . [Table: see text]

Objective: Health coaching has the potential to improve self-management abilities (SM) in patients with Chronic Obstructive Pulmonary Disease (COPD). Patient engagement with health care providers has a beneficial effect on patient outcomes. We examined the association of patient engagement with the health coach on SM abilities in patients with COPD. Methods: We analyzed the association between the degree of engagement measured by the Working Alliance Inventory (WAI-SR) and the SM measured by the Self-Management-Ability-Scale-30 (SMAS-30) at the end of a COPD health coaching intervention. Results: The cohort included 146 moderate to severe COPD patients. The WAI-SR total score was 85% of the maximum possible scores indicating a high degree of engagement between the health coach and the patients. The WAI-SR Task and Bond domains were positively associated with SM abilities after adjusting for lung function (FEV1 %) and depression symptoms (PHQ-2). Conclusion: The degree of engagement between a health coach and patients is associated with the perception of SM abilities in patients with COPD. Our results may inform self-management intervention and clinical practice.

Abstract Rationale Quality of life (QoL) matters the most to patients with chronic obstructive pulmonary disease (COPD) and is associated with healthcare usage and survival. Pulmonary rehabilitation is the most effective intervention in improving QoL but has low uptake and adherence. Home-based programs are a proposed solution. However, there is a knowledge gap on effective and sustainable home-based programs impacting QoL in patients with COPD. Objectives To determine whether remote patient monitoring with health coaching improves the physical and emotional disease-specific QoL measured by the Chronic Respiratory Questionnaire (CRQ). Methods This multicenter clinical trial enrolled 375 adult patients with COPD, randomized to a 12-week remote patient monitoring with health coaching (n = 188) or wait-list usual care (n = 187). Primary outcomes include physical and emotional QoL measured by the CRQ summary scores. Prespecified secondary outcomes included the CRQ domains: dyspnea, CRQ-fatigue, CRQ-emotions, CRQ-mastery, daily physical activity, self-management abilities, symptoms of depression/anxiety, emergency room/hospital admissions, and sleep. Results Participant age: 69 ± 9 years; 59% women; forced expiratory volume in 1 second percent predicted: 45 ± 19. At 12 weeks, there was a significant and clinically meaningful difference between the intervention versus the control group in the physical and emotional CRQ summary scores: change difference (95% confidence interval): 0.54 points (0.36–0.73), P &lt; 0.001; 0.51 (0.39–0.69), P &lt; 0.001, respectively. In addition, all CRQ domains, self-management, daily physical activity, sleep, and depression scores improved (P &lt; 0.01). CRQ changes were maintained at 24 weeks. Conclusions Remote monitoring with health coaching promotes COPD wellness and behavior change, given its effect on all aspects of QoL, self-management, daily physical activity, sleep, and depression scores. It represents an effective option for home-based rehabilitation. Clinical trial registered with clinicaltrials.gov (NCT 03480386).