Preliminary Effects Research Articles

Utidelone plus bevacizumab for the treatment of HER2-negative breast cancer brain metastases (U-BOMB): A multicenter, single-arm phase II study.

1081 Background: The primary treatment for brain metastases in patients with HER2-negative advanced breast cancer is predominantly local therapies like radiotherapy, owing to the limited efficacy of systemic therapies. Prior research has demonstrated utidelone's significant permeability across the blood-brain barrier and the preliminary effectiveness of bevacizumab for breast cancer brain metastases. Consequently, this study investigated the efficacy and safety of utidelone combined with bevacizumab in the treatment of advanced breast cancer brain metastases. Methods: This study was a single-arm, multi-center phase II clinical trial (NCT05357417). Eligible patients were aged 18 years or older with either radiotherapy-naive or progressive brain metastases post-radiotherapy, presented with asymptomatic or symptomatic brain metastases associated with HER2-negative breast cancer.Patients received intravenous bevacizumab (15 mg/kg on day 1 of each 3-week cycle) and utidelone (30 mg/m2 on days 1 to 5 of each cycle) until intolerance or disease progression. The primary endpoint was central nervous system objective response rate (CNS-ORR), as assessed according to the Response Evaluation Criteria In Solid Tumors version 1.1. Results: Between May 5, 2022, and October 25, 2023, a total of 46 patients were recruited, with a median age of 52.5 years (range, 33 to 69). Among them, 35 patients had untreated CNS lesions, while 11 had progressive brain metastases after local radiotherapy. The CNS-ORR was 43.5% (95% confidence interval [CI], 28.9%-58.9%). As of January 8, 2024, the median duration of follow-up was 14.6 months, and the median progression-free survival (PFS) was 7.7 months (95% CI: 5.5-10.8) as shown in Table. The 12-month overall survival (OS) rate reached 74.4% (95% CI: 60.0%-92.3%). The most common grade 1-2 adverse events (AEs) were peripheral neuropathy (87.5%), decreased neutrophil count (62.5%), anemia (47.5%), diarrhea (37.5%), and increased alanine aminotransferase (25%). No grade 3 or higher treatment-related AEs occurred. Conclusions: This study preliminarily shows promising efficacy and manageable safety of the combination of utidelone and bevacizumab in the treatment of HER2-negative metastatic breast cancer patients with brain metastases. Clinical trial information: NCT05357417 . [Table: see text]

Envafolimab in combination with lenvatinib and albumin paclitaxel for previously treated advanced gastric/gastroesophageal junction adenocarcinoma: Preliminary analysis of a phase II, two-cohort study.

e16039 Background: The combination of first-line chemotherapy and PD-1 has emerged as a standard treatment, enhancing the efficacy in advanced gastric/gastroesophageal junction (GEJ) cancer. The efficacy of the combination of second-line chemotherapy and PD-1/PD-L1 remains unclear. This study aims to observe the efficacy of Envafolimab plus tyrosine kinase inhibitors (TKIs) and second-line chemotherapy in the treatment of patients with advanced GEJ adenocarcinoma. Methods: This prospective, open-label, phaseⅡ, two cohort study was conducted to assess the efficacy and safety of Envafolimab-based therapy in patients experiencing progression after initial first-line treatment. Eligible patients with HER2-negative, microsatellite stable (MSS), advanced GEJ adenocarcinoma were consecutively enrolled and assigned into cohort A or cohort B, according to whether they received PD-1 inhibitors in the first-line treatment. Patients in both cohorts received Envafolimab (200mg, hypodermic injection, days 1 and 15, Q4W) combined with Lenvatinib (8mg/12mg, po, once a day) and albumin paclitaxel (100mg/m2, IV, days 1, 8 and 15, Q4W, up to 6 cycles) until disease progression, unacceptable toxicity, or patients refusal to continue treatment. The primary endpoint was objective response rate(ORR) per iRECIST v1.1, and the secondary endpoints included disease control rate (DCR), progression free survival (PFS), overall survival (OS) and safety. The efficacy and safety data in this analysis were from patients in cohort A who previously failed in first-line chemotherapy and did not receive PD-1 or PD-L1 inhibitors ever. Results: From October 2022 to June 2023, cohort A enrolled 16 patients, and 15 of them were evaluable for efficacy analysis. The average age was 58.87 ±11.81 years, 80% patients were male. 6 patients had been tested for PD-L1 status, of which 1 (16.7%) was positive and 5 (83.3%) were negative. As of Jan29, 2024, the median follow-up was 10.6 months (95%CI = 8.67-12.53), the median number of treatment cycles was 7 cycles (IQR: 5, 8). Based on the iRECIST v1.1, the ORR was 60.00% (90% CI = 35.96%-80.91%), the DCR was 100.00% (90% CI = 81.90%-100.00%). The median PFS (mPFS) was 8.23 months (90% CI =6.27-8.61), and the median OS (mOS) was 10.6 months (90% CI =8.79-12.15). Overall incidences of adverse events (AEs) of any grade was 100%, and 75.00% (n = 12) had ≥ grade 3 AEs during treatment. Most treatment-related adverse events (TRAEs) of grade ≥3 included neutrophil count (56.25%), decreased leukocyte count (37.5%). Conclusions: In patients of advanced gastric cancer who have not previously received PD-1/PD-L1 inhibitors, this second-line combination therapy demonstrates promising preliminary effects. Clinical trial information: NCT06030934 .

Feasibility and preliminary effectiveness of a population health management approach to improve cardiovascular risk management in primary care: a mixed-method implementation study

Feasibility and preliminary effectiveness of a population health management approach to improve cardiovascular risk management in primary care: a mixed-method implementation study

Families in transition (FIT) study protocol: feasibility, acceptability and preliminary effects of a group-based parent training in parents of youth in psychiatric residential treatment

IntroductionAlthough adolescents make treatment gains in psychiatric residential treatment (RT), they experience significant difficulty adapting to the community and often do not sustain treatment gains long term. Their parents are...

Pilot Randomized Controlled Trial of Lymfit: A Theory-Guided Exercise Intervention for Young Adults with Lymphoma.

Despite the rapidly emerging evidence on the contributions of physical activity to improving cancer-related health outcomes, adherence to physical activity among young adults with lymphoma remains suboptimal. Guided by self-determination theory (SDT), the Lymfit intervention (a 12-week individualized exercise program with bi-weekly kinesiologist support and an activity tracker) aimed to foster autonomous motivation toward physical activity. This pilot randomized controlled trial aimed to evaluate the feasibility, acceptability, and preliminary effects of Lymfit. Young adults (N = 26; mean age of 32.1 years) with lymphoma who were newly diagnosed and those up to six months after completing treatment were recruited and randomly assigned one-to-one to either the intervention group (n = 13) or a wait-list control group (n = 13). All a priori feasibility benchmarks were met, confirming the feasibility of the study in terms of recruitment uptake, retention, questionnaire completion, intervention fidelity, missing data, Fitbit wear adherence, and control group design. The intervention acceptability assessment showed high ratings, with eight out of ten items receiving >80% high ratings. At post-intervention, an analysis of covariance models showed a clinically significant increase in self-reported physical activity levels, psychological need satisfaction, and exercise motivation in the intervention group compared to controls. Lymfit also led to meaningful changes in six quality-of-life domains in the intervention group, including anxiety, depression, fatigue, sleep disturbance, social roles and activities, and pain interference. The findings support Lymfit as a promising means to meet psychological needs and increase the autonomous motivation for physical activity in this group. A fully powered efficacy trial is warranted to assess the validity of these findings.

Usability, Acceptability, and Preliminary Effectiveness of a Peer-Delivered and Technology-Supported Mental Health Intervention for Family Caregivers of People With Dementia: Field Usability Study.

Family caregivers of people with dementia are critical to the quality of life of care recipients and the sustainability of health care systems but face an increased risk of emotional distress and negative physical and mental health outcomes. The purpose of this study was to examine the usability, acceptability, and preliminary effectiveness of a technology-based and caregiver-delivered peer support program, the Caregiver Remote Education and Support (CARES) smartphone or tablet app. A total of 9 adult family caregivers of people with dementia received the CARES intervention, and 3 former family caregivers of people with dementia were trained to deliver it. Quantitative data were collected at baseline and at the end of the 2-week field usability study. Qualitative data were also collected at the end of the 2-week field usability study. The field usability study demonstrated that a 2-week peer-delivered and technology-supported mental health intervention designed to improve burden, stress, and strain levels was experienced by former and current family caregivers of people with dementia as acceptable. Current family caregivers rated CARES as above average in usability, whereas the caregiver peer supporters rated CARES as marginally usable. CARES was associated with non-statistically significant improvements in burden, stress, and strain levels. This field usability study demonstrated that it is possible to train former family caregivers of people with dementia to use technology to deliver a mental health intervention to current family caregivers of people with dementia. Future studies would benefit from a longer trial; a larger sample size; a randomized controlled design; and a control of covariables such as stages of dementia, years providing care, and severity of dementia symptoms.

An evidence-based breathing exercise intervention for chronic pain management in breast cancer survivors: A phase II randomized controlled trial

ObjectiveExplore the preliminary effects of a breathing exercise (BE) intervention on chronic pain among breast cancer survivors. MethodsThis two-parallel-arm, open-label pilot randomized controlled trial recruited 72 breast cancer survivors who were randomly allocated to either the control or intervention group (n = 36 each). Both groups received usual care and a pain information booklet, while the intervention group received 4 weeks of additional BE. The primary clinical outcome was measured using the Brief Pain Inventory (BPI), with secondary clinical outcomes measured by the Hospital Anxiety and Depression Scale (HADS), Quality of Life Patient/Cancer Survivor Version in Chinese (QOLCSV-C), and Functional Assessment of Cancer Therapy- Breast (FACT-B) immediately post-intervention and at 4-week follow-up. Both adjusted and unadjusted Generalized Estimating Equation models were utilized to assess the BE's potential effects, with safety assessed through participant self-report. ResultsSixty-eight participants completed the study. Statistical significance was observed in BPI in both adjusted and unadjusted models at post-intervention and follow-up (p < 0.05). BE demonstrated positive effects on anxiety, depression and quality of life improvement across all measures and timepoints in both adjusted and unadjusted models (p < 0.05). The effect sizes were smaller in the adjusted model. Three mild transient discomforts were reported associated with BE practice including dizziness, tiredness and yawning, without requirement of medical treatment. No severe adverse events occurred. ConclusionThis BE intervention appears effective in alleviating chronic pain, anxiety and depression, and improving quality of life for breast cancer survivors. Fully powered large-scale studies are required to confirm its effects.

Feasibility, Acceptability, and Preliminary Effectiveness of a Combined Digital Platform and Community Health Worker Intervention for Patients With Heart Failure: Pilot Randomized Controlled Trial.

Heart failure (HF) is a burdensome condition and a leading cause of 30-day hospital readmissions in the United States. Clinical and social factors are key drivers of hospitalization. These 2 strategies, digital platforms and home-based social needs care, have shown preliminary effectiveness in improving adherence to clinical care plans and reducing acute care use in HF. Few studies, if any, have tested combining these 2 strategies in a single intervention. This study aims to perform a pilot randomized controlled trial assessing the acceptability, feasibility, and preliminary effectiveness of a 30-day digitally-enabled community health worker (CHW) intervention in HF. Adults hospitalized with a diagnosis of HF at an academic hospital were randomly assigned to receive digitally-enabled CHW care (intervention; digital platform +CHW) or CHW-enhanced usual care (control; CHW only) for 30 days after hospital discharge. Primary outcomes were feasibility (use of the platform) and acceptability (willingness to use the platform in the future). Secondary outcomes assessed preliminary effectiveness (30-day readmissions, emergency department visits, and missed clinic appointments). A total of 56 participants were randomized (control: n=31; intervention: n=25) and 47 participants (control: n=28; intervention: n=19) completed all trial activities. Intervention participants who completed trial activities wore the digital sensor on 78% of study days with mean use of 11.4 (SD 4.6) hours/day, completed symptom questionnaires on 75% of study days, used the blood pressure monitor 1.1 (SD 0.19) times/day, and used the digital weight scale 1 (SD 0.13) time/day. Of intervention participants, 100% responded very or somewhat true to the statement "If I have access to the [platform] moving forward, I will use it." Some (n=9, 47%) intervention participants indicated they required support to use the digital platform. A total of 19 (100%) intervention participants and 25 (89%) control participants had ≥5 CHW interactions during the 30-day study period. All intervention (n=19, 100%) and control (n=26, 93%) participants who completed trial activities indicated their CHW interactions were "very satisfying." In the full sample (N=56), fewer participants in the intervention group were readmitted 30 days after hospital discharge compared to the control group (n=3, 12% vs n=8, 26%; P=.12). Both arms had similar rates of missed clinic appointments and emergency department visits. This pilot trial of a digitally-enabled CHW intervention for HF demonstrated feasibility, acceptability, and a clinically relevant reduction in 30-day readmissions among participants who received the intervention. Additional investigation is needed in a larger trial to determine the effect of this intervention on HF home management and clinical outcomes. Clinicaltrials.gov NCT05130008; https://clinicaltrials.gov/study/NCT05130008. RR2-10.2196/55687.

A Tailored Intervention for Improving Diabetes Self-care Among Adults With Visual Impairment: A Pilot Study

ObjectivesOur aim in this study was to develop and evaluate a tailored intervention for improving diabetes self-care among people with visual impairment (TID-VI) in South Korea. MethodsThe TID-VI program was designed around the barriers, resources, and perceptual factors to promote diabetes self-care in those with visual impairment (VI). A single-arm pilot study was conducted to evaluate the feasibility and preliminary effects of the intervention. Diabetes self-efficacy, self-care behaviours, depression, health-related quality of life, and clinical outcomes (fasting blood glucose, glycated hemoglobin [A1C], lipids, and blood pressure) were measured before and up to 2 months after the 12-week intervention. ResultsAll 14 participants completed TID-VI. Diabetes self-efficacy, diabetes self-care behaviours, depression, and health-related quality of life showed improvement from baseline that was sustained at 2 months. Although high- and low-density lipoprotein also improved, there were no differences in blood glucose, A1C, total cholesterol, or blood pressure at 2 months. ConclusionsA theory-driven, tailored intervention specific to the needs of adults with VI can produce substantial improvements in patient-reported quality of life and health status outcomes, although the benefits are yet to be confirmed in a controlled study.

Feasibility, acceptability and preliminary effect of a community-led HIV self-testing model among adolescent girls and young women in Rural Northern Uganda: a quasi-experimental study protocol

BackgroundAdolescent girls and young women (AGYW) in sub-Saharan Africa face a disproportionately higher HIV/AIDS burden despite the global decline in incidence. Existing interventions often fail to adequately address their unique social, economic, and cultural challenges, limiting access to essential HIV/AIDS services, including HIV testing. Emerging evidence indicates that HIV self-testing, a user-friendly and confidential method, enhances HIV diagnosis and linkage to care by targeting these barriers. This study aims to assess the feasibility, acceptability, and preliminary impact of a peer-delivered, community-health worker (CHW)-facilitated HIV self-testing intervention for AGYW in Northern Uganda.MethodsThis mixed-methods quasi-experimental implementation science study will employ a three-fold approach. Firstly, we will conduct baseline formative qualitative research with 50 AGYW, 50 parents/partners to AGYW, 30 CHWs, 15 community leaders, and the district health office to inform the design of a peer-delivered CHW-facilitated HIV self-testing intervention tailored to AGYW’s needs in Northern Uganda. Secondly, we will implement a mixed-methods pilot study to assess the intervention’s feasibility and acceptability, involving 415 AGYW, 30 AGYW peer leaders, and 10 CHWs in selected parishes and villages in Omoro district, Northern Uganda. Lastly, we will evaluate the implementation outcomes and preliminary impact of the intervention on HIV self-testing rates and linkage to care by collecting and analyzing quantitative data pre- and post-intervention, laying the groundwork for a future robust randomized controlled trial.DiscussionOur intervention combines CHWs and peer-led strategies to address the unique challenges of AGYW in Northern Uganda, leveraging community resilience and peer influence. Successful completion of this project will provide a scalable model to be evaluated in a randomized trial and replicated in similar contexts.Trial registration numberPACTR202404851907736. Registered with the Pan-African Clinical Trials Registry on April 22, 2024.

A Web-Based Intervention for Insufficiently Active College Students: Feasibility and Preliminary Efficacy.

One third of college students do not achieve aerobic activity levels recommended for physical and mental health. The web-based "I Can Be Active!" intervention was designed to help college students increase their physical activity. The intervention was grounded in the Multi-Process Action Control (M-PAC) framework which emphasizes translating intention into sustainable action. The primary purpose was to evaluate the feasibility of the intervention with insufficiently active young adult college students. The secondary purposes were to describe the preliminary effects of the intervention on: (1) the M-PAC constructs and (2) physical activity. Twenty-one college students, ages 18 to 24, were enrolled in the pre-post quasi-experimental study to test the 8-week intervention during Spring 2021. Data were collected via self-report questionnaires, web-analytics, and interviews. Feasibility outcomes included recruitment, retention, acceptability, practicality, and implementation. Preliminary efficacy outcomes were self-report M-PAC constructs and physical activity. Data analyses included descriptive statistics, t tests, Wilcoxon signed rank tests, Hedge's g, and thematic analysis. Recruitment and retention rates were 70% and 71%, respectively. Participants reacted positively to the program, content, and features, except the manual entry step tracker and private social media group. Positive trends and significant increases were found in the regulatory and reflexive M-PAC constructs (self-regulation, habit, and identity) and physical activity. Findings support the feasibility and preliminary effects of the intervention for insufficiently active college students and highlight implications for intervention refinement. Future research will test intervention effectiveness using a randomized controlled trial with a larger diverse sample of college students.

The Impact of Behavior Change Counseling Delivered via a Digital Health Tool Versus Routine Care Among Adolescents With Obesity: Pilot Randomized Feasibility Study.

Youth overweight and obesity is a public health crisis and increases the risk of poor cardiovascular health (CVH) and chronic disease. Health care providers play a key role in weight management, yet few tools exist to support providers in delivering tailored evidence-based behavior change interventions to patients. The goal of this pilot randomized feasibility study was to determine the feasibility of implementing the Patient-Centered Real-Time Intervention (PREVENT) tool in clinical settings, generate implementation data to inform scale-up, and gather preliminary effectiveness data. A pilot randomized clinical trial was conducted to examine the feasibility, implementation, and preliminary impact of PREVENT on patient knowledge, motivation, behaviors, and CVH outcomes. The study took place in a multidisciplinary obesity management clinic at a children's hospital within an academic medical center. A total of 36 patients aged 12 to 18 years were randomized to use PREVENT during their routine visit (n=18, 50%) or usual care control (n=18, 50%). PREVENT is a digital health tool designed for use by providers to engage patients in behavior change education and goal setting and provides resources to support change. Patient electronic health record and self-report behavior data were collected at baseline and 3 months after the intervention. Implementation data were collected via PREVENT, direct observation, surveys, and interviews. We conducted quantitative, qualitative, and mixed methods analyses to evaluate pretest-posttest patient changes and implementation data. PREVENT was feasible, acceptable, easy to understand, and helpful to patients. Although not statistically significant, only PREVENT patients increased their motivation to change their behaviors as well as their knowledge of ways to improve heart health and of resources. Compared to the control group, PREVENT patients significantly improved their overall CVH and blood pressure (P<.05). Digital tools can support the delivery of behavior change counseling in clinical settings to increase knowledge and motivate patients to change their behaviors. An appropriately powered trial is necessary to determine the impact of PREVENT on CVH behaviors and outcomes. ClinicalTrials.gov NCT06121193; https://www.clinicaltrials.gov/study/NCT06121193.

Improving alcohol and substance use screening in school-age children: translation, adaptation and psychometric evaluation of the CRAFFT tool for Lumasaaba, Uganda

BackgroundChildren at risk of substance use disorders (SUD) should be detected using brief structured tools for early intervention. This study sought to translate and adapt the Car, Relax, Alone, Forget, Family/Friends, Trouble (CRAFFT) tool to determine its diagnostic accuracy, and the optimum cut-point to identify substance use disorders (SUD) risk in Ugandan children aged 6 to 13 years.MethodsThis was a sequential mixed-methods study conducted in two phases. In the first qualitative phase, in Kampala and Mbale, the clinician-administered CRAFFT tool version 2.1 was translated into the local Lumasaaba dialect and culturally adapted through focus group discussions (FGDs) and in-depth interviews, in collaboration with the tool’s authors. Expert reviews and translations by bilingual experts provided insights on linguistic comprehensibility and cultural appropriateness, while pilot testing with the target population evaluated the tool’s preliminary effectiveness. In the second phase, the CRAFFT tool, adapted to Lumasaaba, was quantitatively validated against the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) for diagnosing SUD in Mbale district, through a survey. Participants, chosen randomly from schools stratified according to ownership, location, and school size, were assessed for the tool’s reliability and validity, including comparisons to the MINI KID as the Gold Standard for diagnosing SUD. Data were analyzed using STATA-15. Receiver-operating-characteristic analysis was performed to determine the sensitivity, specificity, and criterion validity of the CRAFFT with the MINI-KID.ResultsOf the 470 children enrolled, 2.1% (n = 10) had missing data on key variables, leaving 460 for analysis. The median age and interquartile range (IQR) was 11 (9–12) years and 56.6% were girls. A total of 116 (25.2%) children had consumed alcohol in the last twelve-month period and 7 (1.5%) had used other substances. The mean CRAFFT score for all the children (n = 460) was 0.32 (SD 0.95). The prevalence of any alcohol use disorder (2 or more positive answers on the MINI KID) in the last 12 months was 7.2% (n = 32). The Lumasaaba version of the CRAFFT tool demonstrated good internal consistency (Cronbach’s α = 0.86) and inter-item correlation (Spearman correlation coefficient of 0.84 (p < 0.001). At a cut-off score of 1.00, the CRAFFT had optimal sensitivity (91%) and specificity (92%) (Area Under the Curve (AUC) 0.91; 95% CI 0.86–0.97) to screen for SUD. A total of 62 (13.5%) had CRAFFT scores of > 1.ConclusionThe Lumasaaba version of the CRAFFT tool has sufficient sensitivity and specificity to identify school-age children at risk of SUD.

Preliminary effectiveness and production time and costs of three-dimensional printed orthoses in chronic hand conditions: an interventional feasibility study.

To assess the preliminary effectiveness of three-dimensional printed orthoses compared with conventionally custom-fabricated orthoses in persons with chronic hand conditions on performance of daily activities, hand function, quality of life, satisfaction, and production time and costs. Interventional feasibility study. Chronic hand orthotic users (n = 21). Participants received a new three-dimensional printed orthosis according to the same type as their current orthosis, which served as the control condition. Primary outcome was performance of daily activities (Patient-Reported Outcomes Measurement Information System-Upper Extremity; Michigan Hand Questionnaire). Secondary outcomes were hand function, quality of life, and satisfaction. Furthermore, production time and costs were recorded. At 4 months' follow-up, no significant differences were found between three-dimensional printed orthoses and participants' existing conventional orthoses on activity performance, hand function, and quality of life. Satisfaction with the three-dimensional printed orthosis was significantly higher and the production time and costs for three-dimensional printed orthoses were significantly lower compared with conventional orthoses. The three-dimensional printed orthosis was preferred by 79% of the participants. This feasibility study in chronic hand conditions suggests that three-dimensional printed orthoses are similar to conventional orthoses in terms of activity performance, hand function, and quality of life. Satisfaction, and production time and costs favoured the three-dimensional printed hand orthoses.

Methodology for adapting a co-created early childhood development intervention and implementation strategies for use by frontline workers in India and Guatemala: a systematic application of the FRAME-IS framework

ABSTRACT There is little evidence on optimizing the effectiveness and implementation of evidence-based early childhood development (ECD) interventions when task-shifted to frontline workers. In this Methods Forum paper, we describe our adaptation of the International Guide for Monitoring Child Development (GMCD) for task-shifting to frontline workers in Guatemala and India. In 2021–2022, implementers, trainers, frontline workers, caregivers, and international GMCD experts collaborated to adapt the GMCD for a task shifted implementation by frontline workers. We used an eight-step co-creating process: assembling a multidisciplinary team, training on the existing package, working groups to begin modifications, revision of draft modifications, tailoring of visual materials and language, train-the-trainers activities, pilot frontline worker trainings, final review and feedback. Preliminary effectiveness of adaptations was evaluated through narrative notes and group-based qualitative feedback following pilot trainings with 16 frontline workers in India and 6 in Guatemala. Final adaptations included: refining training techniques to match skill levels and learning styles of frontline workers; tailoring all visual materials to local languages and contexts; design of job aids for providing developmental support messages; modification of referral and triage processes for children in need of enhanced support and speciality referral; and creation of post-training support procedures. Feedback from pilot trainings included: (1) group consensus that training improved ECD skills and knowledge across multiple domains; and (2) feedback on ongoing needed adjustments to pacing, use of video-based vs. role-playing materials, and time allocated to small group work. We use the Framework for Reporting Adaptations and Modifications to Evidence-based Implementation Strategies (FRAME-IS) framework to document our adaptations. The co-creating approach we use, as well as systematic documentation of adaptation decisions will be of use to other community-based early childhood interventions and implementation strategies.

Yoga improves self-reported cognitive function among cancer survivors: results from the STAYFit trial

IntroductionVarious physical activity-based interventions have been tested to determine their efficacy in improving cancer related cognitive decline (CRCD), however the role of mind-body practices such as yoga remains to be explored. In this manuscript we present preliminary effects of yoga vs. aerobic and stretching-toning modalities of exercise on CRCD among adult cancer survivors.MethodsParticipants (N = 78) were randomized to one of the three exercise groups for a duration of 12-weeks and engaged in ≥150 min per week of supervised group exercises. At baseline and following the 12-week interventions, participants completed the Functional Assessment of Cancer Therapy–Cognitive Function.ResultsResults demonstrated a significant group*time interaction for FACT-Cog perceived cognitive abilities subscale, with participants in the yoga group demonstrating a significant increase as compared to the aerobic and stretching-toning groups. The FACT-Cog total score showed a significant time effect with all groups demonstrating a significant increase at follow-up. Other subscales did not show any significant improvements.DiscussionThese findings provide promising evidence for the effects of yoga on self-reported cognitive function in cancer survivors. Notably, 12-weeks of yoga showed an increase in the perceived cognitive abilities and demonstrated a clinically meaningful increase in total cognitive function as measured by the FACT-Cog, suggesting that this exercise modality has the potential to impact this important health outcome during cancer survivorship.Trial registrationClinicalTrials.gov, identifier: NCT03650322.

Piloting Siyakhana: A community health worker training to reduce substance use and depression stigma in South African HIV and TB care.

South Africa has one of the highest rates of HIV/tuberculosis (TB) co-infection, and poor engagement in HIV/TB care contributes to morbidity and mortality. In South Africa, community health workers (CHWs) are tasked with re-engaging patients who have dropped out of HIV/TB care. CHWs have described substantial challenges with substance use (SU) and depression among their patients, while patients have described CHW stigma towards SU and depression as barriers to re-engagement in care. Yet, CHWs receive little-to-no training on SU or depression. Therefore, we piloted Siyakhana, a brief CHW training to reduce stigma related to SU and depression while improving skills for re-engaging these patients in HIV and/or TB care. This study evaluated the preliminary effectiveness (stigma towards SU and depression; clinical competence assessed via roleplay) and implementation (quantitative ratings of feasibility, acceptability, appropriateness, adoption; semi-structured written qualitative feedback) of Siyakhana among CHWs and supervisors (N = 17) at pre- and post-training assessments. SU stigma significantly decreased (F(1,16) = 18.94, p < 0.001, ηp2 = 0.54). Depression stigma was lower than SU stigma at both timepoints and did not significantly decrease after training. CHW clinical competency towards patients with SU/depression significantly improved (t(11) = -3.35, p = 0.007, d = 1.00). The training was rated as feasible, acceptable, appropriate, and likely to be adopted by CHWs and their supervisors. Nonjudgmental communication was commonly described as the most useful training component. Based on this pilot, the training is being refined and evaluated in a larger randomized stepped-wedge clinical trial.

An interactive shared Reading intervention designed for preverbal infants: A feasibility study exploring early language and cognitive development

An interactive shared Reading intervention designed for preverbal infants: A feasibility study exploring early language and cognitive development

Assessing the Feasibility and Preliminary Effects of a Web-Based Self-Management Program for Chronic Noncancer Pain: Mixed Methods Study.

In Canada, adults with chronic noncancer pain face a persistent insufficiency of publicly funded resources, with the gold standard multidisciplinary pain treatment facilities unable to meet the high clinical demand. Web-based self-management programs cost-effectively increase access to pain management and can improve several aspects of physical and emotional functioning. Aiming to meet the demand for accessible, fully automated resources for individuals with chronic noncancer pain, we developed a French web- and evidence-based self-management program, Agir pour moi (APM). This program includes pain education and strategies to reduce stress, practice mindfulness, apply pacing, engage in physical activity, identify and manage thinking traps, sleep better, adapt diet, and sustain behavior change. This study aims to assess the APM self-management program's feasibility, acceptability, and preliminary effects in adults awaiting specialized services from a center of expertise in chronic pain management. We conducted a mixed methods study with an explanatory sequential design, including a web-based 1-arm trial and qualitative semistructured interviews. We present the results from both phases through integrative tables called joint displays. Response rates were 70% (44/63) at postintervention and 56% (35/63) at 3-month follow-up among the 63 consenting participants who provided self-assessed information at baseline. In total, 46% (29/63) of the participants completed the program. We interviewed 24% (15/63) of the participants. The interview's first theme revolved around the overall acceptance, user-friendliness, and engaging nature of the program. The second theme emphasized the differentiation between microlevel and macrolevel engagements. The third theme delved into the diverse effects observed, potentially influenced by the macrolevel engagements. Participants highlighted the features that impacted their self-efficacy and the adoption of self-management strategies. We observed indications of improvement in self-efficacy, pain intensity, pain interference, depression, and catastrophizing. Interviewees described these and various other effects as potentially influenced by macrolevel engagement through behavioral change. These findings provided preliminary evidence that the APM self-management program and research methods are feasible. However, some participants expressed the need for at least phone reminders and minimal support from a professional available to answer questions over the first few weeks of the program to engage. Recruitment strategies of a future randomized controlled trial should focus on attracting a broader representation of individuals with chronic pain in terms of gender and ethnicity. ClinicalTrials.gov NCT05319652; https://clinicaltrials.gov/study/NCT05319652.

Constructing and Preliminary Testing a Narrative Therapy Programme for Posttraumatic Growth in Chinese Patients With Inflammatory Bowel Disease-A Pilot Study.

The research on posttraumatic growth (PTG) promotion programmes, particularly narrative therapy (NT), for patients with inflammatory bowel disease (IBD) remains limited. This pilot study aims to develop an NT programme to promote PTG and evaluate its feasibility, preliminary effectiveness, participants' experiences and improvement suggestions. The NT programme was initially developed through literature review, interviews with IBD patients and expert panel discussions. A randomized controlled pilot trial was conducted to assess the feasibility and preliminary effectiveness of the programme. Participants in the NT group received five consecutive weekly sessions of the programme, while the control group received standard care. Outcomes including PTG, anxiety, depression and quality of life were measured. Qualitative interviews were conducted to explore participants' experiences and suggestions for programme modifications. The NT programme was developed with scientific rigour. The recruitment rate and retention rate were 62.5% and 96.7%, respectively. A significant reduction in anxiety levels was observed, and manifestations of PTG were reported in the NT group. Suggestions for improvement of the NT programme were received from the participants. The NT programme was constructed to promote PTG in IBD patients in this study, further offering preliminary evidence for its feasibility and potential positive psychological change. However, large-scale research is needed to validate its effectiveness for broader applications.