Preliminary Outcome Data Research Articles

94P Preliminary outcome data for deep inspiratory breath hold guided stereotactic radiotherapy (SBRT) with robotic couch correction for early stage non-small cell lung cancers (NSCLC)

Stereotactic radiotherapy (SBRT) remains a viable option for early stage inoperable non small cell lung cancers (NSCLC). Multitude of delivery platforms and motion management devices been in practice with their own pros and cons. We report the departmental prospectively maintained database for early stage (T1-2a,N0M0 8th edition) NSCLC treated by SBRT with deep inspiratory breathold (DIBH) and robotic couch correction.

Cognitive adaptation training for forensic psychiatry inpatients with schizophrenia spectrum diagnoses

ABSTRACT Cognitive deficits affect 70–75% of individuals with schizophrenia and significantly impact functioning. Cognitive Adaptation Training (CAT) is an evidence-based compensatory intervention that improves functioning through personalized environmental supports. Research has explored adaptations to CAT for specific contexts and sub-populations. The present study explored the feasibility and preliminary outcome data for CAT adapted for inpatient forensic psychiatry settings (finCAT). This study employed a single group mixed-method design collecting data at baseline, post-intervention, and 2-months follow-up. Forensic psychiatry inpatients with schizophrenia spectrum diagnoses (N = 18) participated. Outcomes included room organization, self-care, goal attainment, and qualitative interviews with patients (n = 4) and staff (n = 4), as well as secondary measures of unit climate and clinician attitudes. Data analyses with repeated-measures ANOVA revealed a significant effect of time on blind-rated room organization, with significant improvements at post-intervention sustained during follow-up. There were no significant changes to self-care ratings or secondary measures. Qualitative themes identified included (1) improvement in patients’ self-care and organization; (2) clinicians’ increased awareness of the relationship between cognitive deficits and functional outcomes; (3) improvements beyond self-care and room organization; and (4) increased opportunities for interprofessional collaboration. These results support the feasibility of adapting CAT for inpatient forensic psychiatry settings.

Evaluation of home‐based Family Foundations targeting perinatal mental health and couple conflict in Australia

AbstractObjectivesA formative evaluation of a home‐based family intervention, Family Foundations (FF), targeting parent mental health and conflict in the perinatal period was conducted. The aims were to (a) assess parent satisfaction and recommendations for improvement, (b) identify perceived enablers and barriers to engagement, and (c) obtain preliminary outcome data related to parent mental health, conflict, and coparenting.MethodsA mixed‐methods evaluation was conducted with 41 families at risk of or experiencing parental conflict. FF was delivered by two organizations in Australia. Qualitative interviews with parents and FF clinicians were conducted, and intervention outcomes were assessed using parent survey.ResultsFeasibility of reach and recruitment of the target population was demonstrated. Parents' indicated a high level of satisfaction with all aspects of FF and offered recommendations for improvements to resources and delivery. Service, program, clinician, and family characteristics as enablers and barriers to engagement in FF were identified. Both mothers and partners reported a decrease in their child's exposure to conflict. Mothers also reported a decrease in mental health symptoms and parenting hostility and an increase in positive coparenting behavior.ConclusionFeasibility and acceptability of home‐based FF in the perinatal period had been established, with preliminary evidence of positive outcomes for families.ImplicationsThe current findings generate evidence to inform further development of home‐based FF and wider implementation in health and social care services in Australia.

CTIM-12. A PHASE 1 TRIAL OF IMMUNORADIOTHERAPY WITH THE IDO ENZYME INHIBITOR (BMS-986205) AND NIVOLUMAB IN PATIENTS WITH NEWLY DIAGNOSED MGMT PROMOTER UNMETHYLATED IDHwt GLIOBLASTOMA

Abstract BACKGROUND IDHwt glioblastoma with unmethylated MGMT gene promoter carries a poor prognosis. Preclinical studies have shown that combination of radiotherapy and dual immunotherapy with nivolumab and IDO inhibition significantly prolongs survival of mice with an orthotopic glioblastoma [Ladomersky, et al. CCR 2018;24(11):2559-2573]. In a clinical trial in patients with newly diagnosed glioblastoma with unmethylated MGMT we substituted temozolomide for dual immunotherapy combination. METHODS Phase 1 trial [NCT04047706] using a 3 + 3 dose-escalation design. All received standard radiotherapy (30 x 2 Gy) with addition of once daily oral BMS-986205 and intravenous nivolumab (240mg every 2 weeks) begining on day 1 of radiotherapy and continuing until disease progression or intolerance. BMS-986205 dosing was increased from 50 mg to 100 mg. DLT period encompasses 6 weeks of radiotherapy and the 4 subsequent weeks. Immunocorrelatives being conducted before and after treatment include mass spectrometry for tryptophan and kynurenine levels, immunohistochemistry of resected tumor, and RNA-sequencing and flow cytometric analysis of PBMCs. RESULTS Twelve patients were treated on 2 dose levels of BMS-986205 (50, 100 mg). Treatment-emergent toxicity was as expected for this population. Three (25%) treatment-related SAEs were reported. Dose limiting toxicity of grade 3 transaminase elevation was observed in 2 patients at the 100 mg dose level, while at lower doses of BMS-986205 no substantial alterations of liver enzymes was observed. No other relevant treatment related toxicity occured. Ongoing immunocorrelative profiling and preliminary outcome data (all patients minimal follow-up >12 months) will be available at the time of the meeting. CONCLUSIONS Dose limiting toxicity of BMS-986205 in combination with nivolumab and radiotherapy is hepatic (reversible) transaminitis. The recommended dose for further investigation is 50 mg. Accrual is ongoing for the MGMT promoter methylated cohort using the same regimen without withholding temozolomide. A randomized phase 2/3 trial is approved within the NRG network.

PD Check-In: The development and trial of a supported self-management program for people with Parkinson's disease following intensive speech intervention.

Debilitating speech and communication changes in Parkinson's disease (PD) lead to diminished quality of life for people with PD and their communication partners. Maintenance of the long-term effects of treatment such as LSVT LOUD® remains equivocal. Development of supported long-term maintenance programs is warranted. This article describes the development and preliminary outcome data for PD Check-In, a supported self-management intervention for the maintenance of speech and social communication for people with PD following LSVT LOUD. A narrative literature review of the principles of self-management and social cognitive theory of self-regulation was conducted to develop the core elements of PD Check-In. PD Check-In was conducted in person by a speech and language therapist (SLT) for three participants at 6 and 12 weeks, and at 6, 12 and 24 months following LSVT LOUD. Outcome measures included vocal intensity (SPL) during monologue and the dysarthria impact profile (DIP). PD Check-In utilized semi-structured discussion to develop, evaluate, and support the self-efficacy and skill of the person with PD in maintaining speech and social communication. Six conceptual elements of PD Check-In were identified in the development phase: partnerships, self-reflection, maintenance issues, revision, goal-setting and maintenance strategies. Preliminary intervention data revealed monologue vocal intensity at 24 months post-LSVT LOUD was maintained above pre-treatment level, but below levels achieved post-treatment. The psychosocial impact of speech changes from pre-LSVT LOUD to 24 months post-treatment as measured by the DIP was variable. Qualitative statements reflected participant experiences underlying the clinical data. The theoretical and practical underpinnings of PD Check-In were defined. The impact of PD Check-In on three persons with PD was variable but positive. Further evaluation of the model is warranted. What is already known on the subject LSVT LOUD provides efficacious treatment for the speech disorder associated with PD. Long-term maintenance of speech post-treatment varies following self-managed and group therapy interventions. People with PD have an unmet expectation of long-term maintenance of speech and improved quality of life following intensive treatment. What this paper adds to existing knowledge This study describes the development of a novel clinic-based approach to long-term maintenance of speech in PD based on the principles of self-management and self-efficacy. It provides preliminary data to demonstrate the method and its effects on three participants with varying speech difficulty, self-management skill development and psychosocial impact. What are the potential or actual clinical implications of this work? The positive impact of PD Check-In on the maintenance of monologue vocal intensity above baseline 24 months post-intensive treatment was independent of the variable impact on the quality of life of the participants. Further exploration of PD Check-In is warranted to determine the efficacy of this approach.

A Cyberbullying Media-Based Prevention Intervention for Adolescents on Instagram: Pilot Randomized Controlled Trial.

BackgroundBetween 15% and 70% of adolescents report experiencing cybervictimization. Cybervictimization is associated with multiple negative consequences, including depressed mood. Few validated, easily disseminated interventions exist to prevent cybervictimization and its consequences. With over 97% of adolescents using social media (such as YouTube, Facebook, Instagram, or Snapchat), recruiting and delivering a prevention intervention through social media and apps may improve accessibility of prevention tools for at-risk youth.ObjectiveThis study aims to evaluate the feasibility and acceptability of and obtain preliminary outcome data on IMPACT (Intervention Media to Prevent Adolescent Cyber-Conflict Through Technology), a brief, remote app-based intervention to prevent and reduce the effect of cyberbullying.MethodsFrom January 30, 2020, to May 3, 2020, a national sample of 80 adolescents with a history of past-year cybervictimization was recruited through Instagram for a randomized control trial of IMPACT, a brief, remote research assistant–led intervention and a fully automated app-based program, versus enhanced web-based resources (control). Feasibility and acceptability were measured by consent, daily use, and validated surveys. Although not powered for efficacy, outcomes (victimization, bystander self-efficacy, and well-being) were measured using validated measures at 8 and 16 weeks and evaluated using a series of longitudinal mixed models.ResultsRegarding feasibility, 24.5% (121/494) of eligible participants provided contact information; of these, 69.4% (84/121) completed full enrollment procedures. Of the participants enrolled, 45% (36/80) were randomized into the IMPACT intervention and 55% (44/80) into the enhanced web-based resources groups. All participants randomized to the intervention condition completed the remote intervention session, and 89% (77/80) of the daily prompts were answered. The retention rate was 99% (79/80) at 8 weeks and 96% (77/80) at 16 weeks for all participants. Regarding acceptability, 100% (36/36) of the intervention participants were at least moderately satisfied with IMPACT overall, and 92% (33/36) of the participants were at least moderately satisfied with the app. At both 8 and 16 weeks, well-being was significantly higher (β=1.17, SE 0.87, P=.02 at 8 weeks and β=3.24, SE 0.95, P<.001 at 16 weeks) and psychological stress was lower (β=−.66, SE 0.08, P=.04 at 8 weeks and β=−.89, SE 0.09, P<.001 at 16 weeks) among IMPACT users than among control group users. Participants in the intervention group attempted significantly more bystander interventions than those in the control group at 8 weeks (β=.82, SE 0.42; P=.02).ConclusionsThis remote app-based intervention for victims of cyberbullying was feasible and acceptable, increased overall well-being and bystander interventions, and decreased psychological stress. Our findings are especially noteworthy given that the trial took place during the COVID-19 pandemic. The use of Instagram to recruit adolescents can be a successful strategy for identifying and intervening with those at the highest risk of cybervictimization.Trial RegistrationClinicalTrials.gov NCT04259216; http://clinicaltrials.gov/ct2/show/NCT04259216.

ESTABLISHMENT OF A COMPREHENSIVE CARE PROGRAM (CCP) AS A COMPLEMENT TO FERTILITY EVALUATION/TREATMENT TO IDENTIFY CO-MORBIDITIES, MAXIMIZE AWARENESS AND IMPROVE OVERALL HEALTH, FERTILITY AND OBSTETRICAL OUTCOMES

Maternal health prior to and during pregnancy is of paramount importance, with the best time to optimize maternal health being prior to pregnancy. Reproductive endocrinologists (REI) are often now the sole provider that patients seek when suffering from infertility and thus, have the unique opportunity to counsel women at a critical juncture, not only in relation to pregnancy, but to establish overall optimal health. We aimed to establish a CCP at our center to identify and connect patients in need with all appropriate specialists prior to attempts at pregnancy. All new patients seen at a single site of our academic institution were analyzed for entry eligibility into the CCP based on identified co-morbidities. Participating departments included Maternal Fetal Medicine (MFM), Mental Health (MH), Nutrition, Cardiology, and Endocrinology. Patients were included based on medical and obstetrical history, physical exam, medications &/or laboratory abnormalities (including screening endocrine and lipid assays). Participating CCP providers met monthly to advance the program. Referrals were made internally within the established provider group with a focus on expedited consultations. A database was established to allow results and recommendations to be readily communicated among the team. After excluding patients for missing chart data, 628 new patients were analyzed. Of those, 160 (25%) met entry criteria for the program with 88 (55%) being referred to MFM, 54 (34%) to MH, 23 (14%) to Nutrition, 9 (6%) to Cardiology and 3 (2%) to Endocrinology; some patients were referred to multiple subspecialties. Telemed was extensively utilized. The referral compliance rate for initial CCP consultation reached 100%. Preliminary outcome data shows outcome improvement. Establishment of a CCP focused on those pursuing fertility care along with a detailed initial intake and expanded laboratory panel allowed us to identify approximately 1/4 of our practice requiring referral for consultation with another medical discipline. Streamlining the referral process and Telemed increased compliance. Objective data being collected will determine the impact of early coordinated multidisciplinary-care establishment on obstetric and overall health outcomes. Our CCP program has enhanced the opportunity for our patients to make meaningful and expeditious life changes to maximize health.

A mixed-method evaluation of video interaction guidance (VIG) delivered by early-years workers in a socially disadvantaged urban community

PurposeThe transition to parenthood can pose challenges for women and men, and these are heightened in the context of social disadvantage (e.g. poverty, deprivation, social exclusion, housing instability and disabilities). There is mounting evidence that video-feedback approaches can provide a valuable buffer against such adverse outcomes. This study aims to evaluate the acceptability and preliminary clinical impact of video interaction guidance (VIG), delivered by health visitors and community support workers in a socially disadvantaged London borough, selected due to its multiple indices of deprivation predicting child and maternal adversity.Design/methodology/approachThe study followed a non-randomised, before-and-after evaluation design. Health visitors and community support workers were trained in VIG delivery following the VIG Association-UK protocol. Families with infants under 12 months were conveniently recruited and received six weekly home-based sessions of VIG. The primary outcome was the acceptability of the intervention, assessing parents’ experiences using semi-structured interviews post-intervention. Clinical outcome measures were recorded pre-and post-intervention to yield preliminary evidence on intervention effectiveness.FindingsIn total, 23 families partook in the study, of which 19 completed the pre- and post-VIG quantitative analysis and 6 also completed the post-VIG qualitative interviews. Qualitative analyses documented high rates of acceptability and perceived improvement in family well-being. Preliminary outcome data indicated that completing the VIG intervention was associated with decreased parental anxiety and depression and increased parental confidence, parent-infant relationship quality, as well as an improvement in infant social and emotional development. However, the selective nature of convenience sampling limits the generalisability of the findings. The non-randomised design of the evaluation implies that findings can only be interpreted as preliminary evidence of intervention effectiveness. These considerations are addressed in the discussion.Originality/valueThe results of this study provide preliminary evidence of the acceptability and effectiveness of VIG delivery by health visitors and community support workers to new parents in socially disadvantaged urban communities. However, this study must be pursued further to be evaluated with larger, randomised samples to further explore the generalisability of VIG effectiveness in such settings.

PO-1284 MR-guided radiotherapy of gynecologic cancer – preliminary outcome data from a small cohort study

PO-1284 MR-guided radiotherapy of gynecologic cancer – preliminary outcome data from a small cohort study

A Clinician-Controlled Just-in-time Adaptive Intervention System (CBT+) Designed to Promote Acquisition and Utilization of Cognitive Behavioral Therapy Skills in Bulimia Nervosa: Development and Preliminary Evaluation Study.

BackgroundCognitive behavioral therapy (CBT) for bulimia nervosa (BN) is most effective when patients demonstrate adequate skill utilization (ie, the frequency with which a patient practices or uses therapeutic skills) and skill acquisition (ie, the ability to successfully perform a skill learned in treatment). However, rates of utilization and acquisition of key treatment skills (eg, regular eating, urge management skills, and mood management skills) by the end of the treatment are frequently low; as a result, outcomes from CBT for BN are affected. Just-in-time adaptive interventions (JITAIs) may improve skill acquisition and utilization by delivering real-time interventions during algorithm-identified opportunities for skill practice.ObjectiveIn this manuscript, we describe a newly developed JITAI system called CBT+ that is designed to facilitate the acquisition and utilization of CBT for BN treatment skills when used as a treatment augmentation. We also present feasibility, acceptability, and preliminary outcomes data from a small proof-of-concept pilot trial (n=5 patients and n=3 clinicians) designed to identify opportunities for iterative development of CBT+ ahead of a larger ongoing randomized controlled trial.MethodsA total of 5 individuals with BN received 16 sessions of outpatient CBT for BN while using the CBT+ app. Data were collected from patients and clinicians to evaluate the feasibility (eg, app use and user adherence), acceptability (eg, qualitative patient and clinician feedback, including usefulness ratings of CBT+ on a 6-point Likert scale ranging from 1=extremely useless to 6=extremely useful), and preliminary outcomes (eg, improvements in skill utilization and acquisition and BN symptoms) of the CBT+ system.ResultsPatients reported that CBT+ was a relatively low burden (eg, quick and easy-to-use self-monitoring interface), and adherence to in-app self-monitoring was high (mean entries per day 3.13, SD 1.03). JITAIs were perceived as useful by both patients (median rating 5/6) and clinicians (median rating 5/6) for encouraging the use of CBT skills. Large improvements in CBT skills and clinically significant reductions in BN symptoms were observed post treatment. Although preliminary findings indicated that the CBT+ system was acceptable to most patients and clinicians, the overall study dropout was relatively high (ie, 2/5, 40% patients), which could indicate some moderate concerns regarding feasibility.ConclusionsCBT+, the first-ever JITAI system designed to facilitate the acquisition and utilization of CBT for BN treatment skills when used as a treatment augmentation, was shown to be feasible and acceptable. The results indicate that the CBT+ system should be subjected to more rigorous evaluations with larger samples and should be considered for wider implementation if found effective. Areas for iterative improvement of the CBT+ system ahead of a randomized controlled trial are also discussed.

Pregnancy outcome after first trimester exposure to vortioxetine: A case series.

The objective of this study was to collect outcome after vortioxetine exposure during the first trimester of pregnancy in a case series. Callers who were counseled by the Israeli Teratology Information Service (TIS) regarding vortioxetine exposure during pregnancy were prospectively collected and followed-up by telephone using a structured questionnaire. Outcomes were confirmed by a pediatrician with medical records in the neonatal period. Between 2016 and 2019, a total of 19 women were included in the TIS database after first trimester exposure to vortioxetine. Seventeen pregnancy follow-ups were obtained, while two pregnancies were lost to follow-up. Eleven pregnancies resulted in 12 live births with no malformations including one set of twins; there were three miscarriages, two terminations, and one stillbirth in week 22. One termination was performed due to prenatal diagnosis of acrania (the woman also took carbamazepine, folic acid and dipyrone), and the second due to fear of abnormalities after cystic hygroma was suspected at week 12 with nuchal translucency of 8.1 mm and no further cytogenetic testing. The twins were born in week 35. Two women continued using the medication until delivery; one of these women reported nursing her baby from birth to up to 1 year, while she continued taking vortioxetine. This case series provides preliminary outcome data on vortioxetine exposure in pregnancy. However, the small sample size calls for caution in the interpretation of results. Denominator-based studies are needed before conclusions can be drawn.

What Happens When Training Goes Virtual? Adapting Training and Technical Assistance for the School Mental Health Workforce in Response to COVID-19.

The Northwest Mental Health Technology Transfer Center (MHTTC) provides workforce training and technical assistance (TA) to support evidence-based school mental health practices. Historically, this support targeted school professionals through in-person and online trainings, workshops, and coaching. However, in response to COVID-19 restrictions, all support moved to online formats, and the Center introduced trainings for families and caregivers. The purpose of this article is to present preliminary process and outcome data that compare the reach and impact of support before and following COVID-19-related restrictions. Results suggest that transition to online support resulted in a wider reach and a more diverse audience, with no decrease in trainee satisfaction and perceived impact. Furthermore, families and caregivers reported positive gains in knowledge and behaviors following participation in a virtual youth suicide prevention training. Together, these findings suggest that online training and TA can provide tangible benefits to professionals and family members who support student mental health.

Urban Land-Based Healing: A Northern Intervention Strategy

&#x0D; &#x0D; &#x0D; Urban Indigenous populations face significant health and social disparities across Canada. With high rates of homelessness and substance use, there are often few options for urban Indigenous Peoples to access land-based healing programs despite the increasingly known and appreciated benefits. In May 2018, the first urban land-based healing camp opened in Yellowknife, Northwest Territories, Canada, one of the first to our knowledge in Canada or the United States. This camp may serve as a potential model for an Indigenous-led and Indigenous-based healing camp in an urban setting. We present preliminary outcome data from the healing camp in a setting with a high-risk population struggling with substance use and homelessness. Reflections are presented for challenging logistical and methodological considerations for applications elsewhere. This northern effort affords us ample opportunity for expanding the existing knowledge base for land- based healing applied to an urban Indigenous high-risk setting.&#x0D; &#x0D; &#x0D;

Development and two-phased pilot RCT of a foster/kinship caregiver intervention to improve sexual health communication with youth

PurposeFoster youth have high rates of unintended teen pregnancies and other negative sexual health outcomes. Foster and kinship caregivers (FKC) are an untapped resource to reduce risks. We conducted a two-phase pilot study to evaluate feasibility, acceptability and assess preliminary efficacy of a training designed to improve caregiver communication, monitoring and conflict behaviors and improve sexual health outcomes for youth in foster care. Our study included a Randomized Controlled Trial (RCT) component. MethodPhase 1: We recruited 49 FKC and assessed feasibility quantitatively, and acceptability both qualitatively and quantitatively of our intervention (Heart to Heart). Phase 2: We conducted an RCT with 71 participants and evaluated caregiver communication, monitoring, and conflict behaviors as well as the psychological determinants thereof in intervention and control groups at 1, 3, and 6 months. ResultsPhase 1: Facilitators delivered all intervention content; >90% participants received the entire training. The intervention was highly acceptable (mean score 4.9/5 on two questions). Phase 2: 71 participants were eligible and completed baseline (68 completed at least one follow up survey). We found significant improvements in the intervention group in knowledge, communication expectations, and caregiver-youth conflict behaviors in one or more waves; the control group demonstrated no significant improvements. When groups were compared, we found significant differences in knowledge, communication frequency, and conflict behaviors at 6 months. ConclusionsHeart to Heart is feasible, acceptable, and preliminary outcomes data is promising. More research is needed to better establish evidence of efficacy for long-term behavior change in caregivers and youth.

Pilates for low risk pregnant women: Study protocol for a randomized controlled trial

BackgroundPilates has growing appeal to pregnant women, as a form of exercise and relaxation. It is purported to benefit lumbo-pelvic stability, as well as motor control, strength and endurance. Some suggest that modified Pilates exercises may assist low risk pregnant women to enjoy a healthier pregnancy and prepare for the physical demands of labour and birth. The feasibility and safety of Pilates during pregnancy is poorly understood. We describe the protocol for a feasibility study designed to compare a midwife-led 6-week community-based Pilates intervention with standard antenatal care. MethodsA convenience sample of 30 low-risk pregnant women will be recruited from private obstetric clinics in Melbourne, Australia. Participants shall be randomly allocated to a six-week, 1-h weekly Pilates exercises group session or to usual care. The Pilates exercise class will have a warm-up phase, Pilates exercises, breathing exercises, and a cool down phase. Exercises have been designed to prepare for active birth. The primary outcome will be feasibility of implementation, determined by recruitment, retention, adherence and safety. Secondary outcomes include women's health (quality of life, pain, mobility for daily activities, lower extremity performance, abdominal separation, continence) and labour and birth outcomes (duration of first stage and second stage labour, analgesia used, mode of birth). Validated questionnaires will include the Quality of life 12-item short form survey; Pregnancy Mobility Index, and International Consultation on Incontinence Questionnaire. Lower extremity performance and abdominal separation will also be measured. DiscussionThis trial will provide preliminary data regarding the feasibility and safety of Pilates exercise in healthy pregnant women. It will also provide preliminary outcome data used to inform the design of a future large scale, multi-centre RCT. Trial registrationThis clinical trial has been registered with the Australian and New Zealand Clinical Trials Registry 2016 (ACTRN12616000809437).

Rationalisation of long-term high-dose opioids for chronic pain: development of an intervention and conceptual framework.

There has been a large increase in the number of prescriptions for opioid drugs in the United Kingdom over the last 20 years or more and the prescribing of opioids in high doses continues to increase. Much opioid prescribing is for chronic non-cancer pain (CNCP) despite serious doubts about the long-term effectiveness of opioids for this indication. Clinical experience is that there are increasing numbers of patients who are on high dosages of opioid drugs over sustained periods which provide limited or no pain relief while having significant negative effects on functioning and quality of life. The aim of this article is to bring readers' attention to some clinical observations of the CNCP population with high doses and to describe an intervention to reduce these doses. Many of these patients have no clinical features of addiction; we suggest that those who show little or no substance misuse behaviours are best understood as a distinct clinical population who have different treatment needs. In order to understand and treat these patients, a model is required which, rather than seeing the problem as lying solely with the patient, focuses on the interaction between the individual and his or her environment and seeks a change in what the patient does every day, rather than a simple, and largely unattainable, goal of symptom elimination. The clinician authors worked together to develop an intervention based upon approaches taken from both pain management and psychiatric practice. A detailed description of this rapid opioid reduction intervention (RORI) is provided along with some preliminary outcome data.

HLA-Haploidentical Transplantation in Children with Primary Immunodeficiency Using Post Cyclophosphamide

Introduction Hematopoietic Stem Cell Transplantation (HCT) is considered the curative treatment for patients with Primary Immune Deficiencies (PIDs). Finding a full matched Human leukocyte donor remains an obstacle for performing the bone marrow transplant in a timely fashion. Haplo-identical HCT is an alternative treatment option for patients, who do not have access to full-matched donor. We are reporting preliminary data on our experience of HCT in PID patients using haplo-identical donor with post-transplant Cyclophosphamide. Methods Eleven transplant naive PID patients were infused from June 2017 to August 2018 using a haplo-identical HLA donor at our institution. Eight (72.7%) of the recipients were male. Median age at infusion was 0.9 years (Min: 5.5 months Max: 2.3 years). Primary indications for transplantation included Severe Combined Immune Deficiency (SCID) in seven (63.6%), Omenn Syndrome in two (18.2%), and Chediak-Higashi syndrome and Combined Immunedeficiency in one (9.1%) each. All received GVHD prophylaxis comprising of Cyclophosphamide, Mycophenolate mofetil (MMF), and Cyclosporine regimen. Conditioning regimen was BU/FLU/Thiotepa (±ATG) in six (54.5%) recipients followed by BU/FLU/ATG in four (36.4%). Source of stem cells was bone marrow in ten patients (90.9%) while for the remaining one child PBSC was utilized. Results Eight patients (72.7%) had ANC engraftment with a median time to ANC recovery 15.5 days (Minimum: 13, maximum: 22) whereas, seven (63.6%) of our patients achieved platelets recovery (Median: 33 days, minimum: 16, maximum: 150). In terms of chimeric studies, all but one patient, engrafted at Day +100. Cumulative incidence of aGVHD was 27.3% (n=3); no chronic GVHD was recorded. At a median follow-up of 18.8 months (95% CI: 14.6-23.1), cumulative probability of overall survival at one year from infusion, for our patients is 72.7% (±13.4%). Hemorrhagic cystitis was seen in only one (9.1%) patient while two (18.2%) experienced mucositis (Grade1 or 2). Three (27.3%) contracted CMV infection and were successfully treated.At one-year follow-up lymphoid chimerism remains >95% donor type and CD3:1717 mm3 and CD19 521 mm3 Conclusion Preliminary outcome data on our small cohort of immunodeficiency patients who underwent HCT using Haplo-identical donor with Post-Cy is quite encouraging with durable and stable donor chimerism and CD3 and CD19 engraftment.

A Prospective Pilot Study Evaluating Feasibility and Preliminary Effects of Breathe Easier: A Mindfulness-based Intervention for Survivors of Lung Cancer and Their Family Members (Dyads).

Objective: Symptom burden remains a distressing problem for survivors with non-small-cell lung cancer (stages I-IIIa). This pilot study evaluated feasibility and preliminary effects of a tailored mindfulness-based intervention, Breathe Easier, which encompasses meditation, 2 levels of mindful hatha yoga, breathing exercises, and participant interaction. Methods: Participants were recruited from 2 cancer programs in the US Southeast. A family member was required for participation. Sixty-two participants enrolled (20% recruitment) and 49 completed the intervention (79% retention). Participants chose level 1 yoga (basic) or level 2 (more advanced). Of the completers, survivors were 39% male and 65% Black. A community-based participatory research framework helped identify the specific needs and interests of potential participants and foreseeable barriers to implementation. A 2-month prospective, 1-group, pre-post design evaluated feasibility. Intervention dosage was measured using written protocols. Attendance and completion of daily home assignments measured adherence. Acceptability was assessed using a 10-item questionnaire, completed at three time points. Preliminary outcome data collected pre- and post-intervention tested the hypothesis that participants who received the 8-week intervention Breathe Easier would, post-intervention, demonstrate (a) less dyspnea, (b) less fatigue, (c) less stress, (d) improved sleep, (e) improved anxiety and depression, and (f) improved functional exercise capacity. Exit interviews were conducted, transcribed verbatim, and analyzed for content using descriptive statistics. Results: Quantitative and qualitative measures indicated strong feasibility. Over time, level 1 participants had statistically less dyspnea, fatigue and improved exercise capacity, as well as improved sleep, and stress scores. Level 2 participants experienced slightly increased dyspnea and fatigue but improved sleep, stress, and exercise capacity. All participants experienced anxiety and depression within normal limits pre- and post-intervention. Five major themes emerged out of exit interviews: Learning to Breathe Easier; Interacting with Others as a Personal Benefit; Stretching, Releasing Tension, and Feeling Energized; Enhancing Closeness with Committed Partners; Refocusing on Living; and Sustaining New Skills as a Decision. Conclusions: The study offers insight into the feasibility of an 8-week in-person mindfulness-based intervention with a unique subset of understudied survivors of lung cancer and family members. Outcome data interpretation is limited by the 1-group design and sample size.

Evaluation of reproductive health education in transition-age youth

Foster youth experience increased sexual and reproductive health risks including unintended pregnancy or paternity and sexually transmitted infections compared with other youth. Transition-age foster youth (TAY) experience at least double the rate of pregnancy compared to the general population, yet few researchers have investigated ways to improve the reproductive health of transition-age foster youth. We assessed feasibility and gathered preliminary outcomes data on use of the Making Proud Choices! For Youth in Out-of-Home Care (MPCOOH) curriculum for TAY in extended foster care in Los Angeles County. Of 79 MPCOOH workshop attendees, 72 attended 2 or more sessions, receiving at least half of the curriculum. Of those, 64 attendees provided valid contact information to participate in outcomes research, of whom 54 completed at least 2 of 3 surveys (pre, post, 3-month follow-up), and were thus included in analyses. Participants provided positive feedback after completing the curriculum. Findings showed a significant improvement in sexual and reproductive health knowledge, birth control familiarity, attitudes, and self-efficacy, post-intervention. We demonstrated the feasibility of MPCOOH delivery to TAY in a community setting, as well as finding promising preliminary outcome data. Additional studies are required to determine long-term sexual and reproductive post-intervention behavioral changes in comparison to a control group.

ADAPTING MINDFULNESS-BASED COUNSELING FOR THE TELEPHONE: A PILOT STUDY FOR CAREGIVERS AND VETERANS WITH DEMENTIA

Optimizing Dementia Care in Veterans with Dementia is a randomized, controlled, pilot study examining outcomes for Veterans and their caregivers at 6- and 12-months for two telephone-based interventions: a) Benjamin Rose Institute’s (BRI) Care Consultation (CC), and b) CC + Counseling (CC+C). Counseling modules are integrated into the existing BRI CC framework using guided mindfulness-based skill-building exercises on various content domains (e.g., grief, identity, intimacy, stress management). Sixty-four caregivers and 47 Veterans (M = 74.3 years, MOCA Score M = 15.5) have been randomized in this ongoing pilot study. Caregivers are 91% female, 32% Black/African American, and 72% spouses. Preliminary implementation and 6-month outcome data is discussed (e.g., reaction to behavioral distress, mindfulness, depression, quality of life) using within-group paired samples t-tests for the 32 dyads randomized to CC+C. Lessons learned include strategies for adapting mindfulness-based approaches over the telephone to enhance access for Veterans and caregivers across geographic regions.