Randomized Pilot Trial Research Articles

An Adapted Friendship Bench Counseling Intervention (FB) to Improve Mental Health and HIV Care Engagement Outcomes Among People Living with HIV (PWH) Who Inject Drugs in Hanoi, Vietnam: Results from the VITAL Pilot Randomized Controlled Trial.

Common mental disorders (CMDs) are prevalent among people living with HIV (PWH) and cause morbidity, jeopardize HIV care engagement, and worsen HIV outcomes. In Vietnam, PWH who inject drugs are at high risk for poor HIV and CMD outcomes. However, few evidence-based interventions are available to address this population. We conducted a three-arm individually randomized pilot trial assigning 75 PWH with opiate use disorder and a CMD from methadone maintenance treatment clinics to either FB by a professional counselor, FB by a peer counselor, or enhanced usual care. Primary outcomes were feasibility, acceptability, and fidelity of FB; we also assessed preliminary indicators of CMD improvement and HIV care engagement. Feasibility was high, with 99% retention at 6weeks and 96% retention at 6months. 100% of patients receiving FB attended all 6 weekly sessions. Acceptability of FB was high for participants in both the professional and peer counselor groups. Providers were highly satisfied with the FB experience. Fidelity was adequate: 72% of professional counselors met or exceeded fidelity expectations, while 44% of peer counselors did. Preliminary indicators of effectiveness for CMDs were promising. Participants in the professional counselor arm had the greatest improvement as measured by CMD symptom improvement and CMD response rates at most follow-up visits. The adapted FB intervention should be scaled up and evaluated in a larger, fully powered randomized controlled trial to evaluate its efficacy in improving CMDs and HIV engagement for PWH and CMDs at greatest risk of poor HIV and CMD outcomes.Clinical Trial Number: NCT04790201 registered 3/10/2021.

Evaluating Older Adults' Engagement and Usability With AI-Driven Interventions: Randomized Pilot Study.

Technologies that serve as assistants are growing more popular for entertainment and aiding in daily tasks. Artificial intelligence (AI) in these technologies could also be helpful to deliver interventions that assist older adults with symptoms or self-management. Personality traits may play a role in how older adults engage with AI technologies. To ensure the best intervention delivery, we must understand older adults' engagement with and usability of AI-driven technologies. This study aimed to describe how older adults engaged with routines facilitated by a conversational AI assistant. A randomized pilot trial was conducted for 12-weeks in adults aged 60 years or older, self-reported living alone, and having chronic musculoskeletal pain. Participants (N=50) were randomly assigned to 1 of 2 intervention groups (standard vs enhanced) to engage with routines delivered by the AI assistant Alexa (Amazon). Participants were encouraged to interact with prescribed routines twice daily (morning and evening) and as needed. Data were collected and analyzed on routine engagement characteristics and perceived usability of the AI assistant. An analysis of the participants' personality traits was conducted to describe how personality may impact engagement and usability of AI technologies as interventions. The participants had a mean age of 79 years, with moderate to high levels of comfort and trust in technology, and were predominately White (48/50, 96%) and women (44/50, 88%). In both intervention groups, morning routines (n=62, 74%) were initiated more frequently than evening routines (n=52, 62%; z=-2.81, P=.005). Older adult participants in the enhanced group self-reported routine usability as good (mean 74.50, SD 11.90), and those in the standard group reported lower but acceptable usability scores (mean 66.29, SD 6.94). Higher extraversion personality trait scores predicted higher rates of routine initiation throughout the whole day and morning in both groups (standard day: B=0.47, P=.004; enhanced day: B=0.44, P=.045; standard morning: B=0.50, P=.03; enhanced morning: B=0.53, P=.02). Higher agreeableness (standard: B=0.50, P=.02; enhanced B=0.46, P=.002) and higher conscientiousness (standard: B=0.33, P=.04; enhanced: B=0.38, P=.006) personality trait scores predicted better usability scores in both groups. he prescribed interactive routines delivered by an AI assistant were feasible to use as interventions with older adults. Engagement and usability by older adults may be influenced by personality traits such as extraversion, agreeableness, and conscientiousness. While integrating AI-driven interventions into health care, it is important to consider these factors to promote positive outcomes.

Feasibility and effects of cognitive training on cognition and psychosocial function in Huntington’s disease: a randomised pilot trial

BackgroundHuntington’s disease (HD) is a rare neurodegenerative disease that causes progressive cognitive, physical, and psychiatric symptoms. Computerised cognitive training (CCT) is a novel intervention that aims to improve and maintain cognitive functions through repeated practice. The effects of CCT have yet to be established in HD. This randomised pilot trial examined the feasibility of a large scale trial to assess efficacy of multidomain CCT in pre-manifest and early-stage HD.Methods28 participants were randomised to either at-home CCT (2 × 60 min sessions per week for 12 weeks; n = 13) or lifestyle education through monthly newsletters (n = 15). Participants completed cognitive tasks and questionnaires at baseline and follow up, either in person (n = 18) or via video teleconferencing (n = 10).ResultsAll participants were retained at follow up, and adherence to CCT ranged from 96 to 100%, with 11/13 participants completing all sessions. Preliminary analyses showed evidence of a large effect of CCT on task switching and response inhibition, compared to lifestyle education. There was no evidence of specific benefit to other cognitive domains (processing speed, basic and divided attention, working memory), or psychosocial functions (subjective cognition, mood, health-related quality of life).DiscussionWhilst retention and adherence rates were high, recruitment rates were low, suggesting that a large scale trial may be feasible with some modifications to increase recruitment rates, such as by reducing time burden associated with the study, and using a multi-site trial design. Potential effects on cognitive functioning warrant further investigation.Clinical trial registration: The trial was prospectively registered on the Australian New Zealand Clinical Trials Registry (ACTRN12622000908730).

The safety and feasibility of transcranial direct current stimulation and exercise therapy for the treatment of cervicogenic headaches: A randomized pilot trial.

Our primary objective was to evaluate the safety and feasibility of transcranial direct current stimulation combined with exercise therapy for the treatment of cervicogenic headache. Our exploratory objectives compared symptoms of headache, mood, pain, and quality of life between active and sham transcranial direct stimulation combined with exercise therapy. Cervicogenic headache arises from injury to the cervical spine or degenerative diseases impacting cervical spine structure resulting in pain, reduced quality of life, and impaired function. Current standard-of-care treatments such as radiofrequency ablation, pharmacotherapy, manual therapy, and exercise therapy lack efficacy for some patients. Transcranial direct current stimulation is a neuromodulation technique that has shown promise in treating chronic pain conditions by positively altering neuronal activity but has not been evaluated as treatment for cervicogenic headache. This double-blind, sham-controlled, randomized, feasibility trial recruited 32 participants between the ages of 18 and 65 years that met the International Classification of Headache Disorders third edition criteria for cervicogenic headache. Participants were randomized to receive either active or sham transcranial direct current stimulation both combined with daily exercise therapy over 6 weeks. Transcranial direct current stimulation was applied over the primary motor cortex ipsilateral to worse pain for 20 min at 2 mA with a 30 s ramp up/down period. Recruitment, retention, and adherence were evaluated for feasibility. Safety was assessed through serious and minor adverse events and an adverse effect questionnaire. Clinical outcome measures assessed headache, pain, quality of life, and mood symptoms at pre-treatment, post-treatment, and 6- and 12-weeks post-treatment. A total of 97 participants were contacted to participate with 32 recruited, 16 randomized into each group, and 14 completing the treatment protocol in both groups. Within each group 12 (active) and nine (sham) completed treatment within the proposed 6 weeks (three sessions per week), others received 18 sessions but took longer. Exercise therapy was completed on an average of 87% of days for both groups. Transcranial direct current stimulation was safe, with no serious adverse events and one minor adverse event in the active group. Itching was a more common post-intervention complaint in the active group (64% active vs. 43% sham). Exploratory analysis revealed significant group × time interactions for average headache pain from pre- to post-treatment (β = -1.012, 95% confidence interval [CI] -1.751 to -0.273; p = 0.008), 6-weeks (β = -1.370, 95% CI -2.109 to -0.631; p < 0.001), and 12-weeks (β = -1.842, 95% CI -2.600 to -1.085; p < 0.001) post-treatment, and for neck pain from pre- to post-treatment (β = -1.184, 95% CI -2.076 to -0.292; p = 0.010) and 12-weeks (β = -1.029, 95% CI -1.944 to -0.114; p = 0.028) post-treatment favoring active vs. sham. There were no significant group × time interactions for quality of life or mood. The combination of transcranial direct stimulation and exercise therapy is safe and feasible for treating cervicogenic headache. While some promise has been shown for reducing headache and neck pain, larger scale trials with adequate power are needed to confirm these findings.

Subthalamic and nigral stimulation for freezing of gait in Parkinson's disease: Randomized pilot trial

Background Freezing of gait (FoG) is a debilitating symptom of Parkinson's disease (PD) with limited response to dopaminergic medication and subthalamic deep brain stimulation (STN-DBS). Substantia nigra pars reticulata (SNr) stimulation could improve FoG. Objective To analyze the effect of combined STN-SNr stimulation at different frequencies on FoG. Methods We performed a double-blind, cross-over, randomized pilot trial involving STN-DBS treated PD patients with FoG. Participants received: high-frequency (HF) STN-DBS (S), combined HF-STN and SNr stimulation (C1), and combined HF-STN and low-frequency (LF) SNr stimulation (C2), for one month each. The primary endpoint was the score change in the New-Freezing-of-Gait-Questionnaire (NFOG-Q). Secondary analyses were performed on motor complications, axial symptoms, daily living activities, psychiatric symptoms, sleep, and patient preference. Results Fifteen patients received at least one combined stimulation. No significant difference in NFOG-Q scores was found between S, C1, and C2; one-third of patients showed a clinically significant improvement (≥8 points) with combined stimulations. Motor complications improved significantly with C1 and C2 (C1-S: 3.6 ± 3.8 vs. 4.9 ± 3.8, p = 0.046; C2-S: 2.7 ± 3.1 vs. 4.9 ± 3.8, p = 0.005). 80% of patients preferred the combined STN-SNr stimulation while blinded. All adverse events were manageable. Conclusions Our study did not prove a statistically significant improvement in NFOG-Q with STN-SNr stimulation; however, one-third of patients experienced a clinically meaningful FoG improvement, and the majority preferred to maintain STN-SNr stimulation. STN-SNr stimulation was both safe and effective in addressing motor complications and improving sleep quality, highlighting the importance of further exploration into the effects of combined STN-SNr stimulation.

Tongue Muscle Training App for Middle-Aged and Older Adults Incorporating Flow-Based Gameplay: Design and Feasibility Pilot Study.

Complications due to dysphagia are increasingly prevalent among older adults; however, the tediousness and complexity of conventional tongue rehabilitation treatments affect their willingness to rehabilitate. It is unclear whether integrating gameplay into a tongue training app is a feasible approach to rehabilitation. Tongue training has been proven helpful for dysphagia treatment. Following the development of a tongue training app, a feasibility trial aimed to identify physiological and psychological factors that affect user and flow experience and explored whether training specialized muscles could produce a flow experience for optimal immersion. We aimed to provide a useful tool for medical rehabilitation so that older adults could retain tongue muscle flexibility. After consulting professional nurses, we developed a mobile gaming app for middle-aged and older adults to train their tongue muscles. This pilot study used an image recognition system to detect the tongue movements of 32 healthy middle-aged and older adults (7 males, 21.9%; 25 females, 78.1%) during 3 game training tasks, each requiring different reaction speeds. Their physiological and psychological signals, as well as the results of the Flow State Scale 2 (FSS2) questionnaire, were used for correlation analysis regarding relevant flow experiences to establish and evaluate the feasibility of our method. Through exploratory factor analyses, a 2-factor (operation and immersion) structure was confirmed to have an adequate model fit (χ²36=448.478; P<.001; Kaiser-Meyer-Olkin=0.757) and internal consistency reliability (Cronbach α=0.802). The slow, medium, and fast levels all significantly affected the FSS2 score for operation (P=.001), the National Aeronautics and Space Administration Task Load Index (P<.001), and flow distance (P<.001). K-means clustering revealed that participants could be further categorized into 3 groups. Through the analysis of changes in the participants' physiological and psychological signals for each given task, Pearson correlation indicated that changes were primarily related to flow distance. For the 12 indicators measured in this study, the low, medium, and high operation groups showed significance in 58% (7/12), 50% (6/12), and 25% (3/12) of the indicators, respectively. Similarly, the low, medium, and high immersion groups had changes in 50% (6/12), 33% (4/12), and 17% (2/12) of indicators, respectively. Our research supports the further development of a gaming app to aid older adults with tongue muscle training and measure flow using physiological and psychological signals to enhance training accuracy and feasibility. Next, we aim to conduct a randomized pilot trial, improve app functions, offer alternative rehabilitation options, and encourage long-term participation. Future goals include enhancing long-term efficacy, diversifying training modes, and adding a multiuser interactive option for an added challenge.

A 3-Month Dual-Task Exercise Randomized Pilot Trial Improves Dynamic Stability and Coordination in Community-Dwelling Older Adults.

Dual-task (DT) exercises combine both physical and cognitive activities and have the potential to efficiently enhance both physical and cognitive function. This study aimed to determine if, compared with exercise-only (EO) and control (C) groups, adults in a DT training program improved measures of cognitive and/or physical functioning. Thirty-five participants (Mage = 65.7 ± 8.5years; 74.3% female, 25.7% male) were randomly sorted into EO (n = 15), DT (n = 10), and C (n = 10). EO and DT participated in 3months of twice weekly, 50-min exercise. DT played cognitive games on a SMARTfit Cognitive-Motor Exercise System during exercise sessions. C did not participate in any supervised sessions. Cognition was assessed with a Cognivue Thrive program. Dynamic stability, coordination, and lower body strength were assessed. Linear mixed-effects models investigated effects for different groups. For outcomes showing significant (p < .05) differences, pairwise t tests were conducted between all treatment and time comparisons. Dynamic stability and coordination improved in DT and EO (p = .002 and .04, respectively), but not in C in the first 6weeks (p = .58). Cognition and memory did not change over time among the three groups. Healthy, independent-living older adults in either DT or EO improved dynamic stability and coordination over time and DT improved balance and functional mobility more than either EO or C. No improvements in several standard cognition or memory measurements were observed. Significance/Implications: A DT exercise program improved balance and coordination, but not cognition or memory, in healthy, independent-living older adults.

A randomized pilot trial of two forms of behavioral economics intervention to improve adherence to buprenorphine-naloxone among patients with opioid use disorder.

A randomized pilot trial of two forms of behavioral economics intervention to improve adherence to buprenorphine-naloxone among patients with opioid use disorder.

Self-acupressure for patients with breast cancer experiencing aromatase inhibitor-associated musculoskeletal symptoms: Protocol for the AcuAIM randomized pilot trial.

Aromatase inhibitors (AI) reduce hormone receptor-positive breast cancer recurrence risk by about 50%. However, half of AI-treated postmenopausal women report new or worsened musculoskeletal symptoms (AIMSS), and 20% discontinue therapy prematurely. Acupuncture is effective for reducing symptoms, but many women are not able to access acupuncture therapy. We hypothesize that self-administered acupressure will reduce AIMSS. Postmenopausal women who have been receiving treatment with an AI for more than 3 weeks but less than 2 years, and who report new or worsened joint pain or myalgias since starting AI therapy with worst pain of at least 4 out of 10 on a numerical rating scale, are eligible. Fifty participants will be enrolled and randomized 1:1 to treatment with true or sham acupressure for 12 weeks. Participants will self-apply pressure for 3 minutes to each of the 9 acupoints daily. All participants will complete a pain assessment weekly, and a battery of symptom questionnaires every 6 weeks. Optional stool samples will be collected after 0 and 12 weeks of acupressure to examine changes in the gut microbiome. The primary endpoint is change in worst pain on the Brief Pain Inventory-Short Form with 12 weeks of the acupressure intervention, evaluated with generalized estimating equations. Determination that self-administered acupressure reduces AIMSS in this randomized phase 2 pilot trial will lead to a larger randomized phase 3 clinical trial to confirm the efficacy of self-acupressure. Reduction of AI-related arthralgias may improve persistence with breast cancer therapy, breast cancer outcomes, and quality of life for AI-treated patients. Clinicaltrials.gov NCT06228768.

Efficacy of the Once-Daily Tacrolimus Formulation LCPT Compared to the Immediate-Release Formulation in Preventing Early Post-Transplant Diabetes in High-Risk Kidney Transplant Patients: A Randomized, Controlled, Open-Label Pilot Study (EUDRACT: 2017-000718-52).

Background/Objectives: Post-transplant diabetes mellitus (PTDM) and prediabetes (PreDM) are common after renal transplantation and increase the risk of cardiovascular events and mortality. Compared to immediate-release tacrolimus (IR-Tac), the LCPT formulation, with delayed absorption, offers higher bioavailability and a smoother time-concentration curve, potentially reducing beta-cell stress. Methods: This randomized pilot trial compared de novo immunosuppression with IR-Tac (twice daily) and LCPT (once daily). At-risk recipients (age ≥ 60 years or 18-59 years with metabolic syndrome) were enrolled and followed for 3 months. The primary and secondary outcomes were the incidence of PTDM and PreDM, respectively. Results: 27 patients were randomized to IR-Tac and 25 to LCPT. The incidence of PTDM was comparable between groups [IR Tac: 18.5% (95% CI: 8.2-36.7%) vs. LCPT: 24% (95% CI: 11.5-43.4%); p = 0.7]. Although not statistically significant, the LCPT group exhibited a trend toward a reduction in PreDM incidence [IR-Tac: 40.7% (95% CI: 25-59%) vs. LCPT: 20% (95% CI: 9-39%); p = 0.1]. A sensitivity analysis showed similar results, with no significant differences in cumulative corticosteroid doses or baseline body mass index (BMI) between groups. The LCPT group showed a trend toward higher tacrolimus exposure at the end of the study [trough levels: IR-Tac group 8.3 (6.9-9.2) vs. LCPT group 9.4 (7.4-11.4) ng/mL; p = 0.05)], as well as fewer acute rejection episodes (none vs. three). Delayed graft function was more common in the IR-Tac group (37% vs. 8%; p = 0.01), and the eGFR was lower. Adverse events were comparable between groups. Conclusions: The potential biological activity of LCPT in preventing glucose metabolic alterations in at-risk patients warrants further investigation.

Active Learning Through Video Conferencing to Maintain Physical Activity Among Older Adults: A Pilot Randomized Controlled Trial.

This randomized pilot trial investigated the feasibility of an active learning physical activity intervention through video conferencing and its preliminary effects. Participants comprised community-dwelling older adults who could use e-mail. The intervention group underwent a 12-week active learning intervention via video conferencing to promote a healthy lifestyle, particularly physical activity. The control group received information via e-mail once per week. The amount of physical activity and sedentary behavior was measured using an accelerometer at baseline, postintervention, and 24-week postintervention (36weeks). Of the 31 participants, 29 were eligible and randomized into two groups (15 for the intervention and 14 for the control). Adherence to the intervention was 83%-100% (mean, 97%). Compared with the control group, the intervention group showed moderate maintenance effects on total physical activity and sedentary behavior at 36weeks. Active learning physical activity intervention through video conferencing was found to be feasible and contributed to the prevention of physical activity decline in older adults.

A peer support intervention in patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT): The STEPP randomized pilot trial design and methods

BackgroundDespite the association between peer support interventions and improved patient-reported outcomes (PROs) across cancer populations, there is a lack of structured peer support interventions for patients with hematologic malignancies undergoing hematopoietic stem cell transplantation (HSCT). ObjectiveTo test the feasibility, acceptability, and preliminary efficacy of a novel five-session, phone-delivered peer support intervention (STEPP: Supporting Transplant Experiences with Peer Program) for improving quality of life (QOL) and reducing psychological distress in patients undergoing HSCT. MethodsThis single-center pilot randomized clinical trial (RCT) will compare the STEPP intervention to usual transplant care among 90 patients hospitalized for HSCT. Eligible participants include adults (age ≥ 18 years) with hematologic malignancies hospitalized for autologous or allogeneic HSCT. The STEPP intervention provides informational, emotional, and practical support. To test the primary aim of intervention feasibility, we have established a priori benchmarks of 60 % enrollment of eligible patients and 60 % completion of at least 3 out of 5 intervention sessions among those randomized to STEPP. Acceptability will be assessed using the Client Satisfaction Questionnaire, with scores ≥3.0/4.0 indicating greater intervention acceptability. To test the secondary aim of preliminary efficacy, we will examine changes in PROs (e.g., anxiety symptoms and QOL) from pre- to post-intervention. DiscussionThis pilot RCT of a structured, phone-delivered peer support intervention tailored to the needs of patients preparing to undergo HSCT will elucidate the feasibility, acceptability, and preliminary efficacy of the STEPP intervention. We will then be poised to conduct a future, full-scale RCT to establish the efficacy of STEPP on patient outcomes.ClinicalTrials.gov: NCT 06010017.

A Randomized Pilot Trial of Virtual Reality Surgical Planning for Head and Neck Oncologic Resection.

Application of virtual reality (VR) for surgical planning may improve clinical outcomes for head and neck cancer (HNC) resection. There is a lack of randomized trials and meaningful metrics to assess such technological applications. Our objective was to evaluate the feasibility of a VR protocol for oncologic surgical planning and assess the impact on surgical outcomes. A randomized controlled trial utilizing a VR Case Enhancement Protocol (VRCEP) versus standard of care (SOC) surgical planning was conducted. The primary endpoint was feasibility, defined as >80% successful VRCEPs. Metrics included surgeon task-load burden (TLB) using the NASA Task-Load Index and "margin events," defined as "the need for defect-driven margins, positive frozen margins, and/or positive final margins." Margin events were used to calculate a margin event score (MES) per case and margin event rate (MER) per cohort. Thirty-four patients were included in the final analysis (17 VRCEP, 17 SOC) with 94.4% of eligible VRCEP cases completed (17/18). Surgeon TLB was unchanged with VRCEP. Cases undergoing VRCEP were associated with a lower mean MES (0.27 vs. 0.94, p = 0.014) and MER (11.6% vs. 35.6%, p = 0.0041). VRCEP was associated with decreased defect-driven margins (10% vs. 53.3%, p = 0.032). Although not statistically significant, positive frozen and final margin rates were lower in VRCEP. Completion of the VRCEP was feasible with no significantincrease in surgeon TLB appreciated. VRCEP yielded fewer MEs. Further investigation into the benefit of VR in HNC resection is warranted. Margin events may represent useful metrics for assessing novel surgical technologies. 2 Laryngoscope, 2024.

Identical movement control exercises with and without synchronized breathing for chronic non-specific low back pain:A randomized pilot trial.

Exercise is a first-line treatment for chronic non-specific low back pain (CNSLBP). Exercise combined with specific breathing techniques have the potential to improve multifactorial outcomes. No previous studies, however, have compared outcomes between identical exercises with or without a specific breathing protocol in a uniform clinical study setting. 1) To investigate the feasibility of combining synchronized breathing with movement control exercises and evaluate eligibility criteria, randomization procedures, and dropout rates. 2) To study the preliminary efficacy of the interventions on multifactorial outcome measures. Thirty subjects with CNSLBP were randomized into two groups. Both groups had four contact clinic visits where they received personalized home movement control exercises to practice over two months. The experimental group included a movement control exercise intervention combined with synchronized breathing techniques. Trial registration number: NCT05268822. Feasibility was demonstrated by meeting the recruitment goal of 30 subjects within the pre-specified timeframe with enrolment rate of 24.8% (30/121). Synchronized breathing techniques were successfully adhered by participants. Home exercise adherence was nearly identical between the groups without any adverse events. Preliminary efficacy findings on pain intensity, disability, and self-efficacy in the experimental group exceeded the minimal clinically important difference. No such findings were observed in any outcome measures within the control group. Overall, multifactorial differences were consistent because nine out of eleven outcome measures showed greater improvements for the experimental group. The synchronized breathing with movement control exercises protocol was feasible and may be more beneficial for improving multifactorial outcomes compared to identical exercises alone. Results suggested progression to a full-scale trial.

Effects of Intimate Partner Violence Prevention Programming on Social Support, Coparenting, and Parenting Among Teen Parents: A Pilot Study

Understanding mechanisms and secondary outcomes of intimate partner violence (IPV) prevention programs for teen parents can help to improve relationships. This study used data from a randomized pilot trial of the Safe Dates for Teen Mothers IPV prevention program compared to the original Safe Dates program with 32 teen mothers recruited from four community-based sites. We examined effect sizes of cross-sectional associations between IPV, social support, coparenting, and parenting, and of differences between the adapted program and the original on social support, coparenting, and parenting over 6 months. Effect sizes of associations were medium on average. Effect sizes on social support, coparenting, and parenting favored the adapted program over the original program and were medium to large. IPV prevention programs adapted for teen parents have the potential to support positive dynamics in their social relationships. These preliminary estimates can inform the design of larger research and intervention studies.

The Effect of a Tailored Educational Flyer on Colorectal Cancer Screening Among Rural Residents: Lessons Learned from a Pilot Randomized Trial.

Background/Objectives: Stool-based tests, such as the fecal immunochemical test (FIT), have been widely used for increasing colorectal cancer (CRC) screening. Small media, such as printed materials or flyers, are known to be an effective intervention to increase CRC screening by fecal tests. However, more evidence is needed to determine whether such small media are effective in improving screening uptake of a mailed FIT intervention targeted at rural populations in the USA. Methods: In this randomized study, 1230 FIT kits were mailed from July to December 2022 to rural Nebraskans aged 45-74 who were not up to date on CRC screening. Half of the participants (n = 608) also received a tailored, one-page, gender-specific educational flyer created based on focus groups with rural residents. Logistic regression was used to determine predictors of returning the FIT. Results: Study participants were predominantly female (76%), non-Hispanic White (83%), and within the age group of 55-64 (43%). Overall, 192 (15.6%) kits were returned (16.1% from the flyer group; 15.1% from the no-flyer group). However, we found no significant differences between the flyer and no-flyer groups (Adjusted Odds Ratio [AOR]: 1.21; 95% CI: 0.88-1.66). Females (AOR: 1.78; 95% CI: 1.19-6.14) and the oldest (65-74) age group (AOR: 5.03; 95% CI: 2.78-8.47) were more likely to return FIT kits than males and the youngest (45-54) age group. Conclusions: A tailored educational flyer was not effective in improving the CRC-screening-rate-by-mailed-FIT approach for rural populations. Future research should explore the content, timing, and mode of delivery of educational interventions as well as other multi-component strategies to improve screening rates. Public health officials might also consider developing strategies targeted at males and younger (45-54) age groups.

Randomized pilot trial of an unconditional cash transfer intervention to address food insecurity in oncology.

Screening for food insecurity and other social determinants of health is being integrated into oncology practice. We performed a pilot randomized trial to investigate whether an unconditional cash transfer (UCT) could be used to address food insecurity among female breast and gynecological cancer survivors. Food-insecure cancer survivors completed a baseline survey and were randomly assigned to receive $100/month for 3 months (UCT) or usual care (UC). Participants (n = 14) completed a follow-up survey after 3 months, and we compared changes in health-related quality of life, indicators of food insecurity, diet quality, and whether a participant had to forgo, delay, or make changes to medical care because of cost. The UCT was associated with higher physical health scores, fewer indicators of food insecurity, better diet quality, and a lower likelihood of forgoing medical care than those who received UC. Our results suggest that UCTs can improve outcomes for food-insecure cancer survivors.

A sham-controlled randomised pilot trial on baroreflex activation therapy in patients with resistant hypertension: What will the future hold?

A sham-controlled randomised pilot trial on baroreflex activation therapy in patients with resistant hypertension: What will the future hold?

Cardiovascular handgrip responses during treadmill exercise: randomized pilot trial.

The isometric exercise performed using the handgrip (HG) acutely promotes elevation of systolic blood pressure (SBP) and diastolic blood pressure (DBP), and in a non-consensual manner among articles elevation or maintenance of heart rate (HR). Currently, although there is a vast literature on the hemodynamic effects of interval training and isometric exercise with HG alone, there is still no consistent evidence of such adjustments occurring in the association between the two. Therefore, the objective of this study was to describe the acute hemodynamic responses found only during interval training and when combined with isometric contraction with HG. This is a pilot study of a crossover clinical trial. Seven male volunteers, aged 24±3.9 years, underwent three protocols on an ergometric treadmill, with a 3-minute warm-up at 30% of heart rate reserve (HRR), four sprints 2 minutes at 50% HRR and active intervals at the same speed as the warm-up. Randomization was carried out in a simple random manner. The protocols were classified according to the use of HG during sprints, as follows: PI = without HG; PII = HG 30% of handgrip strength (HGS) and PIII = 60% of HGS). Variations (Δ) in HR, double product (DP), SBP and DBP were evaluated. The presence of HG did not change HR behavior, but it increased DP (PI: 10,472±2,539 vs. PII: 12,217±1,933 vs. PIII: 13,369±3,089) through SBP, which in PI had a plateau behavior of 15±22.2 mmHg, while PII varied with an average of 41±12.2 mmHg and PIII 47±11.1 mmHg, in the 4th sprint. DBP fell in PI with 12±13.2 mmHg, while PII and PIII showed an drop of 0±19.6 and 6±13.0 mmHg in the last sprint, respectively. The use of HG during interval training directly modulates hemodynamic variables, promoting an increase in SBP elevation, attenuation of the drop in DBP and an increase in DP, without an increase in HR. RBR-78fhyrf. Available in https://ensaiosclinicos.gov.br/rg/RBR-78fhyrf.

Managing Cancer and Living Meaningfully in adults with brain metastases: A NIH ORBIT model phase II feasibility and proof-of-concept trial

Abstract Background Managing Cancer and Living Meaningfully (CALM) is a brief, evidence-based psychotherapy designed to help patients with advanced cancer cope with the practical and profound challenges of their illness. However, no study has systematically examined CALM in adults with brain metastases, despite the well-documented incidence of distress in this growing population. The primary aim of this trial was to assess the feasibility and acceptability of CALM in adults with brain metastases. Methods Patients with brain metastases (N = 13) and elevated symptoms of depression and/or death anxiety enrolled in this single-arm trial. CALM was administered in 6 biweekly sessions, with outcomes assessed at baseline and post-intervention. Feasibility was assessed based on established metrics including enrollment and retention rates. Acceptability was measured by post-session surveys and post-intervention interviews. Preliminary signal change on measures of psychological distress was explored. Results Of the 13 enrolled participants, 11 completed baseline assessments and initiated treatment: 73% female, Mage = 58 years (SD = 12.9; range = 37–75). Nine completed the study (81% retention rate). Overall, participants reported high perceived benefits and would recommend the program to others. Baseline to post-intervention assessments indicated improvements in depression, death anxiety, generalized anxiety, post-traumatic stress, suicidal ideation, and spiritual well-being. Life quality, substance use, and fear of cancer recurrence remained relatively stable. Conclusions CALM is feasible and acceptable and may improve psychological distress in adults with brain metastases. The findings of this study align with our previous trial of patients with malignant glioma and support a future National Institute of Health Obesity Related Behavioral Intervention Trials phase II randomized pilot trial of CALM in neuro-oncology. Trial Registration Number NCT05087095 registered on March 23, 2022.