Citations

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 < 0.001; 0.51 (0.39–0.69), P < 0.001, respectively. In addition, all CRQ domains, self-management, daily physical activity, sleep, and depression scores improved (P < 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).

Rural patients are often underrepresented in cancer clinical trials. This is a secondary analysis of a study that tested short (2000 word) versus long (6000 word) consent forms with a focus on rurality. Among 240 patients, 89 (37%) were rural. Seventy-one (80%) rural and 117 (77%) nonrural patients signed a consent form of any length ( P = .68). Forty-one of 47 (87%) rural patients signed a short consent form; in contrast, 30 of 42 (71%) signed a long form. These trends suggest rural patients are more likely to sign short consent forms. Further study is indicated.

e24094 Background: Hundreds, if not thousands, of participants are enrolled hot flash trials each year given the magnitude of the problem for breast and prostate cancer survivors. Classically, these studies have included a baseline period of 1-week, or longer, to understand the frequency and severity of hot flashes before starting a new treatment. The objective of the current study was to compare the accuracy of a 1-day baseline hot flash diary to a more traditional 1-week dairy. A shorter baseline period would be more convenient for patients and provide a more efficient study design. Methods: Raw data from 5 pilot studies and 15 phase III randomized, controlled trials (RCTs), all of which used a one-week baseline period, were obtained. Descriptive statistics were used to describe day-by-day variations in hot flash frequencies and scores, during the baseline week. Additional analyses evaluated whether the conclusions from any of the individual pilot studies would have been changed if only a 1-day baseline period had been used. For the RCTs, p-values were recalculated using mixed models, adjusting for the baseline value by including it as a covariate. Results: A total of 2,573 participants were included. On average, participants had 8.5 hot flashes per day on Day 1. Mean hot flash frequencies and scores on subsequent days (Days 2-7) were within 6% of Day 1 values. When comparing a 1-day to a 1-week baseline period, there was an absolute difference of only 0.29 hot flashes per day (SD 2.25). Re-analysis for each pilot study revealed that no individual study conclusions would have been meaningfully altered by a shorter baseline. For the RCTs, a shorter baseline period changed the results of only 1 of 24 comparisons from statistically significant to not significant, or vice versa. Conclusions: A 1-day hot flash diary appears to accurately reflect true frequency and severity of baseline hot flash symptoms in appropriately sized cohorts. Results support a shorter baseline period for pilot studies and RCTs.

Purpose: The purpose of this study was to characterize the material, health (general and diabetes-specific), and social impacts of the COVID-19 pandemic on Hispanic adults with type 2 diabetes who did not experience COVID-19 infection. Methods: This cross-sectional and longitudinal study used surveys within a clinical trial of 79 Hispanic adult clinic patients with type 2 diabetes. Cross-sectional measures included the Coronavirus Anxiety Scale, items from the Coronavirus Impact Scale, and the Pandemic Impacts Inventory. Longitudinal measures included the Summary of Diabetes Self-Care, health care utilization, and measures of diabetes self-efficacy, social support, and quality of life. Results: Participants were majority low-income, Spanish-speaking females with poor diabetes control. Coronavirus anxiety was low despite majority of participants having an affected family member and frequent access barriers. More than half of participants reported moderate/severe pandemic impact on their income. Diabetes self-care behaviors did not change between prepandemic and pandemic measures. Diabetes self-efficacy and quality of life improved despite fewer diabetes-related health care visits. Conclusions: Despite high levels of access barriers, financial strain, and COVID-19 infection of family members, Hispanic adults with type 2 diabetes continued to prioritize their diabetes self-management and demonstrated substantial resilience by improving their self-efficacy and quality of life.

Background In clinical trials and clinical practice, patient-reported outcomes are almost always assessed using multiple patient-reported outcome measures at the same time. This raises concerns about whether patient responses are affected by the order in which the patient-reported outcome measures are administered. Methods This questionnaire-based study of order effects included adult cancer patients from five cancer centers. Patients were randomly assigned to complete questionnaires via paper booklets, interactive voice response system, or tablet web survey. Linear Analogue Self-Assessment, Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events, and Patient-Reported Outcomes Measurement Information System assessment tools were each used to measure general health, physical function, social function, emotional distress/anxiety, emotional distress/depression, fatigue, sleep, and pain. The order in which the three tools, and domains within tools, were presented to patients was randomized. Rates of missing data, scale scores, and Cronbach’s alpha coefficients were compared by the order in which they were assessed. Analyses included Cochran–Armitage trend tests and mixed models adjusted for performance score, age, sex, cancer type, and curative intent. Results A total of 1830 patients provided baseline patient-reported outcome assessments. There were no significant trends in rates of missing values by whether a scale was assessed earlier or later. The largest order effect for scale scores was due to a large mean score at one assessment time point. The largest difference in Cronbach’s alpha between the versions for the Patient-Reported Outcomes Measurement Information System scales was 0.106. Conclusion The well-being of a cancer patient has many different aspects such as pain, fatigue, depression, and anxiety. These are assessed using a variety of surveys often collected at the same time. This study shows that the order in which the different aspects are collected from the patient is not important.

Purpose To examine the feasibility and acceptability of a social network weight loss intervention delivered by lay health promoters (HPs) to immigrant populations. Design Single-arm, non-randomized, pilot study of a social network weight loss intervention developed by a community-based participatory research partnership and delivered by HPs. Setting Community-based setting in Southeastern Minnesota, United States. Sample Somali and Hispanic immigrants to the United States: 4 social networks of adults (2 Hispanic and 2 Somali) with 39 network participants. Intervention Twelve-week behavioral weight loss intervention delivered by HPs (4 weeks in-person and then 8 weeks virtual). Measures Feasibility was assessed by recruitment and retention rates. Acceptability was assessed by surveys and focus groups with HPs and participants. Behavioral measures included servings of fruits and vegetables, drinking soda, and physical activity. Physiologic measures included weight, blood pressure, glucose, cholesterol, and triglycerides. Analysis Paired t-tests of pre- to post-intervention changes at the end of 12 weeks of treatment. Results Recruitment was feasible and post-intervention was 100%. Participants highly rated the intervention on satisfaction, motivation, and confidence to eat a healthy diet, be physically active, and lose weight. Participants were motivated by group social support and cohesion of their social networks. On average, participants lost weight (91.6 ± 15.9 to 89.7 ± 16.6 kg, P < .0001), lowered their systolic blood pressure (133.9±16.9 to 127.2 ± 15.8 mm Hg; P < .001), lowered their diastolic blood pressure (81 ± 9.5 to 75.8 ± 9.6 mm Hg; P < .0001), had more servings of vegetables per day (1.9 ± 1.2 to 2.6 ± 1.4; P < .001), and increased their physical activity (2690 ± 3231 to 6595 ± 7322 MET-minutes per week; P = .02). Conclusion This pilot study of 2 immigrant communities who participated in a peer-led weight loss social network intervention delivered during the COVID-19 pandemic demonstrated high feasibility and acceptability. Participants lost weight, improved their health status, and improved their health behaviors.