Novotny, Paul

Abstract Background: Self-efficacy theory proposes that confidence to engage in a health behavior is associated with engaging in that specific behavior. Most research examining self-efficacy has been conducted with white young adult populations. This secondary analysis examined the association of self-efficacy (i.e., confidence) for healthy eating and physical activity in two immigrant communities. Methods: At enrollment into the Healthy Immigrant Community study, a clinical weight management and cardiovascular risk reduction intervention set in southeastern [state], 475 participants completed assessments about their confidence for healthy eating and physical activity. Measurements also included self-reports of dietary quality and intake, physical activity, quality of life, and biometric assessments. Study materials were available in English, Spanish, and Somali. Results In total, 450 adults (Hispanic/Latinx = 267; Somali = 183) completed measures at baseline and were included for analysis. Their average age was 45 years (range 18–87) and 59% were female. Confidence for healthy eating was significantly associated with self-report of eating healthy snacks ( p = < 0.0001) and less consumption of high-calorie drinks ( p = 0.02) and regular soda ( p = < 0.0001). Confidence to be physically active was significantly associated with more self-reported physical activity ( p = < 0.01). Conclusions Confidence to eat healthy and be physically active appears to be associated with having a healthier diet and higher levels of physical activity. Given the large sample size and strength of the associations, it also appears that the theoretical model of self-efficacy can be effectively measured and applied within these immigrant populations. Self-efficacy theory may be useful in understanding potential mediating mechanisms when designing future interventions with immigrant communities. ClinicalTrials.gov registration: NCT05136339; April 23, 2022

Background: Chemotherapy-induced peripheral neuropathy (CIPN) from oxaliplatin and taxane drugs is a bothersome toxicity. Palmitoylethanolamide (PEA) has been reported to improve myelinated nerve fiber function in patients experiencing painful CIPN. We conducted a double-blind, placebo-controlled, randomized trial of PEA in patients with established CIPN. Methods: Eligible patients were adults who had pain, numbness, tingling, or other symptoms of CIPN for at least three months following completion of paclitaxel, oxaliplatin, or cisplatin-based chemotherapy. Study patients were randomized to one of the two treatment groups (PEA versus placebo, both administered either once or twice daily). The CIPN20 questionnaire was assessed weekly. Results: A total of 17 males and 71 females participated in the study; most had neuropathy from paclitaxel. Most (85%) finished 8 weeks of treatment. There was no suggestion that either of the PEA arms did any better than the combined placebo arms. There was no signal of significant toxicity differences between the three study arms. Quality of life outcome measures were similar between the study arms, as were cognitive function evaluations. Discussion: PEA failed to improve established CIPN. Future trials might explore whether PEA may be effective in preventing CIPN or cognitive changes based on data that suggest it may be helpful in this situation. Conclusions: PEA failed to improve established chemotherapy-induced neuropathy.

Background: Patients have been known to use cannabinoids for treating established chemotherapy-induced peripheral neuropathy (CIPN) based on anecdotal information and retrospective reports suggesting that such might be beneficial. In response, a double-blinded, placebo-controlled, randomized, pilot clinical trial was developed to evaluate whether resultant data would support a phase III trial for testing whether a cannabidiol (CBD) cream might improve CIPN. Methods: Forty patients with established CIPN were randomized, in a double-blinded manner, to topical CBD or a placebo cream. The study product was applied for 2 weeks, followed by a crossover for 2 weeks. Neuropathy was evaluated using the European Organization of Research and Treatment of Cancer (EORTC)–CIPN20, the Chemotherapy-Induced Peripheral Neuropathy Assessment Tool, and the Global Impression of Change instruments. Side effects were recorded by symptom diaries. Results: The EORTC-CIPN20 scores were similar in the patients receiving CBD versus the placebo. Likewise, the toxicity scores were similar in patients who received the CBD versus the placebo. Conclusions: This pilot trial did not support that the studied CBD isolate cream improved painful established CIPN. It was well tolerated overall. Clinical Trial Registration Number: NCT05388058

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).

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.

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.