Single-arm Feasibility Study Research Articles

A novel technique for transoral ultrasound-guided aspiration of peritonsillar abscess – a single-arm feasibility study

Introduction Peritonsillar abscess is a common complication to acute tonsillitis in younger adults. The primary treatment is surgical drainage, but it can be challenging to distinguish cellulitis from peritonsillar abscess on a standard clinical examination. This study aims to explore whether a novel technique for transoral ultrasound can improve the diagnostic accuracy and guide successful surgical drainage in patients with peritonsillar infections. Methods Patients referred to departments of Otorhinolaryngology, Head and Neck Surgery at Rigshospitalet with peritonsillar abscess was offered a transoral ultrasound as a supplemental to their standard clinical examination. The ultrasound exam was performed with a bk5000 machine (BK Medical®) and a Burr-Hole N11C5s transducer with an in-plane needle guide attached. The proportion of successful needle aspirations, complications, and diagnostic accuracy was evaluated. Results We included eighteen patients in the analysis, and all the patients tolerated the transoral ultrasound exam. Nine of the patients had peritonsillar abscess, while six had tonsillitis/peritonsillar cellulitis and three mononucleosis. Eleven patients had needle aspirations performed, of which two were without aspiration of pus. The sensitivity was found to be 100%, and the specificity was 78%. Conclusion Point-of-care transoral ultrasound was feasible and without complications in this study. Further, we found clinical benefits of adding transoral ultrasound to the diagnostic workup of patients with peritonsillar infections.

Massage for Symptom Management in Adult Inpatients With Hematologic Malignancies.

BackgroundPatients undergoing hematopoietic stem cell transplant often suffer from a predictable constellation of side effects related to therapy. Nonpharmacologic treatments for these side effects are attractive adjuncts to therapy due to a low side-effect profile.ObjectiveTo develop, implement, and evaluate a pilot program of massage therapy for symptom management in adult patients with hematologic malignancies admitted to the bone marrow transplant (BMT) service at a large academic medical center.MethodsA single-arm feasibility study of massage therapy was conducted. Pre- and postintervention surveys were collected to assess the usefulness in management of 7 symptoms.ResultsOver an 11.5-month period, 109 patients received 142 massage treatments. one in five patients received more than one massage. We received surveys on 134 massage treatments. Patients reported significant reductions in anxiety, distress, fatigue, pain, and tension (P < .01) and improved sleep as a result of massage therapy.ConclusionBased on this pilot, massage therapy is a feasible and safe intervention to administer during BMT hospitalizations. It proved useful in managing a constellation of 5 side effects including, anxiety, distress, fatigue, pain, and tension.

PRELUDE Prospective Study of the Serranator Device in the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Popliteal Arteries

Purpose: To evaluate the safety and efficacy of the Serranator Alto PTA Serration Balloon Catheter in subjects with peripheral artery disease in the superficial femoral and popliteal arteries. Materials and Methods: A prospective, multicenter, single-arm feasibility study enrolled 25 patients (mean age 66 years; 18 men) to evaluate Serranator inflation and postinflation effects under monitoring by independent core laboratories. Inclusion criteria were claudication or ischemic rest pain, de novo lesions or native artery restenosis, >70% stenosis, lesion length <10 cm, and a reference vessel diameter of 4 to 6 mm. Chronic total occlusions (CTO) up to 6 cm in length were allowed (n=8). The primary safety endpoint was 30-day major adverse events. Primary efficacy outcome was device success with final diameter stenosis <50%. The secondary objective was to confirm the presence of serrations across the lesions using optical coherence tomography (OCT) or intravascular ultrasound (IVUS) following treatment in a subset of 10 subjects. Follow-up evaluations were conducted at 30 days and 6 months. Results: Technical success of device delivery and retrieval was 100%. The primary safety endpoint was met, with no patients experiencing a major adverse event in the first 30 days. Pretreatment stenosis of 88% was reduced to 23%. One stent was implanted for grade D dissection in a CTO. The core laboratory–adjudicated primary patency was 100% at 1 month and 64% at 6 months. Serrations were confirmed in all 10 OCT/IVUS images reviewed by the core laboratory. The Rutherford category showed significant and sustained improvement at 6 months. Conclusion: The Serranator is a safe and efficacious angioplasty balloon catheter system. This new design provides an exciting potential for optimizing vessel preparation and aiding drug delivery.

Clinical Evaluation of the Cook Advance Enforcer 35 Focal-Force PTA Balloon Catheter for Treatment of Hemodialysis Fistula Stenoses: A Feasibility Study

PurposeA prospective, single-center, single-arm feasibility study evaluated procedural and short-term performance of the Advance Enforcer 35 focal-force percutaneous transluminal angioplasty (PTA) balloon catheter in treating stenoses of mature native arteriovenous (AV) hemodialysis access circuits. Materials and MethodsTwenty-eight patients undergoing treatment for stenosis of a mature native AV hemodialysis access circuit were enrolled at a single institution. Angiographic assessments of the study lesion were required at baseline and after the procedure. Adjunctive procedures for significant residual stenosis were permitted, and patients had clinical and imaging follow-up for as long as 6 months. ResultsTreatment with the study balloon was effective in reducing the average percent diameter stenosis of the treated lesion from 66.3% (range, 43.8%–93.3%) before the procedure to 23.7% (range, −6.7% to 51.4%) after the procedure. The average inflation pressure required was 12.3 atm. Only 1 patient required an adjunctive procedure, and all patients could resume normal dialysis following the study procedure. At 3 months, 62.0% of study lesions remained patent, and the 6-month patency rate was 25.1%. Two adverse events associated with the study procedure were reported: access-site hematoma and forearm pain (3.6% each). ConclusionsThe results demonstrate safety of the study balloon in treating AV access stenosis. Nominal-diameter angioplasty was achieved at relatively low pressure in most study patients without the use of adjunctive procedures, and resumption of normal dialysis was achieved for all patients.

Fractional CO2 laser therapy for genitourinary syndrome of menopause (GSM) in survivors of breast cancer (BC).

202 Background: Fractional CO2 laser therapy is an emerging treatment for GSM. The objective of this study was to determine the feasibility, tolerability and preliminary efficacy of fractional CO2 laser therapy in BC survivors. Methods: This was a single arm feasibility study of BC survivors with dyspareunia and/or vaginal dryness. Participants received three treatments with office-based fractional CO2 laser on at least 30 day intervals and returned for a one-month follow-up. Feasibility was defined as treatment completion without serious adverse events (SAE) in a minimum of 80% of patients. Primary efficacy was evaluated using the mean change (∆) in the score on the Vaginal Assessment Scale (VAS). Secondary efficacy endpoints included mean ∆ in scores on the Female Sexual Function Index (FSFI) and Urogenital Distress Inventory (UDI). Descriptive statistics (means and 95% confidence intervals (CI) for continuous variables and proportions for categorical variables) were used. Results: The study is ongoing with 65 patients enrolled. To date, 37 patients have completed all study treatments and follow-up. Median age for those who have completed treatment was 57 years (range 34-72). Most were ER/PR positive (78%) and Her 2 negative (81%) with stage I (43%) or II (41%) BC. Ninety-five percent were receiving endocrine therapy, most commonly aromatase inhibitors (73%). No SAEs were reported in the 37 patients who have completed study treatments and their outcomes are as follows. Based on the VAS, 78% reported moderate-severe dyspareunia and 89% reported moderate-severe vaginal dryness at baseline. At follow up, 28% reported moderate-severe dyspareunia and 28% reported moderate-severe vaginal dryness. The VAS score improved from baseline to follow up (mean ∆ 4.1; 95% CI [3.1, 5.1]). Similarly, the FSFI score improved (mean ∆ -10.0; 95% CI [-13.2, -6.9]) and the UDI score improved (mean ∆ -5.7; 95% CI [-10.1, -1.3]). Final efficacy analysis will be reported once all patients have completed all time points. Conclusions: Fractional CO2 laser treatment is feasible and tolerable in BC survivors and may reduce symptom burden from GSM. A randomized controlled trial with sham laser is currently in development. Clinical trial information: NCT03307044.

Transcranial direct current stimulation for online gamers: A prospective single-arm feasibility study.

AimExcessive use of online games can have negative influences on mental health and daily functioning. Although the effects of transcranial direct current stimulation (tDCS) have been investigated for the treatment of addiction, it has not been evaluated for excessive online game use. This study aimed to investigate the feasibility and tolerability of tDCS over the dorsolateral prefrontal cortex (DLPFC) in online gamers.MethodsA total of 15 online gamers received 12 active tDCS sessions over the DLPFC (anodal left/cathodal right, 2 mA for 30 min, 3 times per week for 4 weeks). Before and after tDCS sessions, all participants underwent 18F-fluoro-2-deoxyglucose positron emission tomography scans and completed the Internet Addiction Test (IAT), Brief Self Control Scale (BSCS), and Beck Depression Inventory-II (BDI-II).ResultsAfter tDCS sessions, weekly hours spent on games (p = .02) and scores of IAT (p < .001) and BDI-II (p = .01) were decreased, whereas BSCS score was increased (p = .01). Increases in self-control were associated with decreases in both addiction severity (p = .002) and time spent on games (p = .02). Moreover, abnormal right-greater-than-left asymmetry of regional cerebral glucose metabolism in the DLPFC was partially alleviated (p = .04).ConclusionsOur preliminary results suggest that tDCS may be useful for reducing online game use by improving interhemispheric balance of glucose metabolism in the DLPFC and enhancing self-control. Larger sham-controlled studies with longer follow-up period are warranted to validate the efficacy of tDCS in gamers.

POLST Facilitation in Complex Care Management: A Feasibility Study.

The Physician Orders for Life-Sustaining Treatment (POLST) form is an advance care planning tool designed for seriously ill patients. The discussions needed for high-quality POLST decision-making are time intensive and often do not occur in the outpatient setting. We conducted a single-arm feasibility study of POLST facilitation by nonphysicians using Respecting Choices Last Steps, a standardized, structured approach to facilitation of POLST conversations. Community-dwelling adults aged 65 and older enrolled in a complex care management program in a Midwestern urban hospital. We assessed the feasibility and acceptability by determining the proportion of eligible patients who enrolled and completed the study, by adherence to the Respecting Choices protocol, and by responses to qualitative and quantitative survey items about the intervention. We enrolled 18 (58.1%) of 31 eligible patients, with a mean age of 77.8 years (standard deviation: 6.95); 12 were African American. The POLST facilitation was delivered to all 18; 10 (55.6%) completed POLST forms. Direct observation of intervention delivery using a checklist found 85% of the required elements were performed by facilitators. We completed 6- to 8-week follow-up interviews in 16 of 18 patients (88.9%). We found 87.5% of decision makers agreed or strongly agreed that "Talking about the (POLST) form helped me think about what I really want." The POLST facilitation can be successfully delivered to frail older adults in a complex care management setting, with high fidelity to protocol. Further research is needed to demonstrate the effects of this approach on decision quality and other patient-reported outcomes.

Being Present: A single-arm feasibility study of audio-based mindfulness meditation for colorectal cancer patients and caregivers.

A metastatic cancer diagnosis is associated with high levels of distress in patients and caregivers. Mindfulness interventions can reduce distress and improve quality of life in cancer patients. However, standard mindfulness training relies on in-person instruction, which is often not practical for either patients receiving chemotherapy or their caregivers. In the Being Present single arm pilot study, we designed and tested an 8-week audio-based mindfulness meditation program for patients with metastatic colorectal cancer receiving chemotherapy with or without a participating caregiver. The study accrued 33 of 74 (45%) eligible patients consenting together with 20 family caregivers (53 participants total) within nine months. Forty-one participants were evaluable (77%); 10 of 12 cases of attrition were attributable to hospitalization or death. Median participant age was 51 (range 21–78 years); 38% were men. Baseline levels of distress were similar in patients and caregivers. The top reasons for participation cited in pre-intervention interviews were to increase relaxation/calm, improve mood/emotions, and reduce stress/anxiety. In measures of adherence, 59% of responses to weekly texts asking: “Have you practiced today?” were “Yes” and 59% of interviewees reported practicing >50% of the time. Compared to baseline, post-intervention surveys demonstrated significantly reduced distress (p = 0.01) and anxiety (p = 0.03); as well as increased non-reactivity (p<0.01), and feeling at peace (p<0.01). Post-intervention qualitative interviews, where 71% of participants reported benefit, were consistent with quantitative findings. In the interviews, participants spontaneously described reduced stress/anxiety and increased relaxation/calm. Benefits appeared to be accentuated in patient-caregiver pairs as compared to unpaired patients. Seventy-nine percent of participants reported plans for continued practice after study completion. We conclude that the Being Present audio-based mindfulness meditation program is of interest to, feasible, and acceptable for patients with metastatic colorectal cancer and caregivers, with initial evidence of efficacy. These results will guide plans for a follow-up study.Trial registration: ClinicalTrials.gov NCT02423720

Evaluation of SAMe-TT2R2 Score on Predicting Success With Extended-Interval Warfarin Monitoring

In patients with stable international normalized ratios, 12-week extended-interval warfarin monitoring can be considered; however, predictors of success with this strategy are unknown. The previously validated SAMe-TT2R2 score (considering sex, age, medical history, treatment, tobacco, and race) predicts anticoagulation control during standard follow-up (every 4 weeks), with lower scores associated with greater time in therapeutic range. To evaluate the ability of the SAMe-TT2R2 score in predicting success with extended-interval warfarin follow-up in patients with previously stable warfarin doses. In this post hoc analysis of a single-arm feasibility study, baseline SAMe-TT2R2 scores were calculated for patients with ≥1 extended-interval follow-up visit. The primary analysis assessed achieved weeks of extended-interval follow-up according to baseline SAMe-TT2R2 scores. A total of 47 patients receiving chronic anticoagulation completed a median of 36 weeks of extended-interval follow-up. The median baseline SAMe-TT2R2 score was 1 (range 0-5). Lower SAMe-TT2R2 scores appeared to be associated with greater duration of extended-interval follow-up achieved, though the differences between scores were not statistically significant. No individual variable of the SAMe-TT2R2 score was associated with achieved weeks of extended-interval follow-up. Analysis of additional patient factors found that longer duration (≥24 weeks) of prior stable treatment was significantly associated with greater weeks of extended-interval follow-up completed ( P = 0.04). Conclusion and Relevance: This pilot study provides limited evidence that the SAMe-TT2R2 score predicts success with extended-interval warfarin follow-up but requires confirmation in a larger study. Further research is also necessary to establish additional predictors of successful extended-interval warfarin follow-up.

19.4 CAT IN FIRST-EPISODE PSYCHOSIS: FEASIBILITY, ACCEPTABILITY AND POTENTIAL TO ENHANCE VOCATIONAL RECOVERY

BackgroundCognitive and functioning impairments are present early in the course of psychotic disorder and remain one of the greatest treatment challenges in this population. While Cognitive Adaptation Training (CAT) is found to improve a range of outcomes in chronic schizophrenia, it has received limited investigation in first-episode psychosis (FEP). CAT may be particularly useful for addressing vocational recovery in FEP because the cognitive impairments experienced by individuals with FEP predict poorer vocational outcomes and impede the effectiveness of vocational interventions such as supported employment. The aim of this presentation is to present the findings of a pilot study investigating the feasibility and acceptability of CAT in young people with FEP and to describe the clinical considerations and adaptations required when delivering CAT with this population. Preliminary findings on the potential value of CAT in improving vocational outcomes in FEP will also be presented.MethodsThis was a single-arm feasibility study of CAT conducted at the Early Psychosis Prevention and Intervention Centre (EPPIC), Melbourne, Australia. Five FEP participants received 9 months of manually-guided CAT. A range of feasibility and acceptability measures were recorded, including participant and case manager satisfaction ratings. Participants’ goals, functional needs and clinical observations and adaptations were also recorded. Formal measures of functioning, quality of life and motivation were independently administered pre- and post-intervention.ResultsAll participants completed the CAT intervention and session attendance rates were very high (95.3%). Participants and their case managers indicated strong satisfaction with CAT as indicated by overall positive mean ratings on the satisfaction items. CAT did not negatively affect existing case management, with case managers reporting that it enhanced their treatment. Vocational recovery (education, employment) was found to be a primary functional goal of most participants. Accordingly, the CAT intervention had a strong focus on vocational functioning, including functional domains that are requisite for successful work or educational outcomes, including organisation and planning, transportation and activities of daily living. Being mindful of factors that may be common in young FEP patients included cognitive heterogeneity, family involvement, flexibility in compensatory and environmental supports used, and the experience of stigma. There were mean improvements from baseline to post-intervention on most formal outcome measures, with the largest effects in global functioning, planning and organisation, and quality of life.DiscussionThis study provides encouraging preliminary evidence that CAT is a highly feasible and acceptable intervention in FEP, which may be easily integrated within existing early intervention services. Vocational recovery is important to young people with FEP. CAT is an intervention that appears well suited to addressing this need. The effectiveness of CAT in improving functional outcomes, particularly vocational recovery in FEP warrants further investigation in a larger trial.

The SABRE Trial (Sirolimus Angioplasty Balloon for Coronary In-Stent Restenosis): Angiographic Results and 1-Year Clinical Outcomes

ObjectivesThe aim of this first-in-human study was to assess the safety and effectiveness of the Virtue sirolimus-eluting balloon in a cohort of patients with in-stent restenosis (ISR). BackgroundAngioplasty balloons coated with the cytotoxic drug paclitaxel have been widely used for ISR treatment. The Virtue angioplasty balloon (Caliber Therapeutics, New Hope, Pennsylvania) delivers sirolimus in a nanoencapsulated liquid formulation. This clinical trial is the first to examine a sirolimus-eluting balloon for ISR. MethodsIn this prospective, single-arm feasibility study at 9 European centers, 50 ISR patients were treated with the Virtue balloon. Angiographic measurements at 6 months are reported, along with 12-month clinical follow-up. ResultsProcedural success in the intention-to-treat population was 100%. The primary safety endpoint was target lesion failure (TLF) (cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization) assessed at 30 days (0%, n = 50). The primary performance endpoint was in-segment late lumen loss (LLL) at 6 months (0.31 ± 0.52 mm; n = 47). Secondary 6-month endpoints include binary restenosis (19.1%), diameter stenosis (30.3 ± 19.9%), and major adverse cardiac events (MACE) (10.2%, n = 49). In the 36-patient per-protocol population (excluding major protocol violations and previously stented ISR), LLL was 0.12 ± 0.33 mm at 6 months. Clinical outcomes at 1 year for the intention-to-treat group were 12.2% TLF and 14.3% MACE and for the per-protocol population were 2.8% TLF and 2.8% MACE. ConclusionsThis first-in-human study showed excellent procedural success for the Virtue sirolimus-eluting angioplasty balloon, 6-month LLL rates in line with current stent-free ISR treatment options, and clinical outcomes that warrant further evaluation in dedicated randomized studies.

Effects of Bu-Zhong-Yi-Qi-Tang for the treatment of functional dyspepsia: a feasibility study protocol

BackgroundBu-Zhong-Yi-Qi-Tang (BZYQT) has long been used for the treatment of severe weakness caused by general fatigue, loss of appetite, or indigestion. The aim of this feasibility study is to assess the effectiveness and safety of BZYQT for the treatment of functional dyspepsia (FD) with spleen qi deficiency. MethodsThis study will be conducted at a single center as a prospective, nonrandomized, nonblinded, single-arm feasibility study. A total of 30 participants diagnosed with FD in accordance with the Rome III criteria will be enrolled. All patients will receive BZYQT for 4 weeks. The primary outcome is the change in the Nepean Dyspepsia Index-Korean version (NDI-K) scores between the baseline and 4-week images. The secondary outcomes include the tongue coating thickness, blood parameters, and BZYQT Questionnaire score. The NDI-K score will be acquired four times, at Weeks 0 (baseline), 2 (during treatment), 4 (after treatment), and 8 (after follow-up). Written informed consent will be obtained from all study participants prior to enrollment. This study has been approved by the Institutional Review Board of Kyung Hee University Korean Medicine Hospital. This study protocol is registered with the national clinical trial registry of the World Health Organization International Clinical Trials Registry Platform. Results will be published in a journal and will be disseminated both electronically and in print. DiscussionThe results of this study may serve as a guide for researchers seeking to effectively evaluate the effects of BZYQT. Trial Registration No.KCT0002114 (date of registration: October 21, 2016).

Sympathetic Response and Outcomes Following Renal Denervation in Patients With Chronic Heart Failure: 12-Month Outcomes From the Symplicity HF Feasibility Study

BackgroundHeart failure (HF) is associated with chronic sympathetic activation. Renal denervation (RDN) aims to reduce sympathetic activity by ablating the renal sympathetic nerves. We investigated the effect of RDN in patients with chronic HF and concurrent renal dysfunction in a prospective, multicenter, single-arm feasibility study. Methods and ResultsThirty-nine patients with chronic systolic HF (left ventricular ejection fraction [LVEF] <40%, New York Heart Association class II-III,) and renal impairment (estimated glomerular filtration rate [eGFR; assessed with the use of the Modification of Diet in Renal Disease equation] < 75 mL • min−1 • 1.73 m−2) on stable medical therapy were enrolled. Mean age was 65 ± 11 years; 62% had ischemic HF. The average number of ablations per patient was 13 ± 3. No protocol-defined safety events were associated with the procedure. One subject experienced a renal artery occlusion that was possibly related to the denervation procedure. Statistically significant reductions in N-terminal pro–B-type natriuretic peptide (NT-proBNP; 1530 ± 1228 vs 1428 ± 1844 ng/mL; P = .006) and 120-minute glucose tolerance test (11.2 ± 5.1 vs 9.9 ± 3.6; P = .026) were seen at 12 months, but there was no significant change in LVEF (28 ± 9% vs 29 ± 11%; P = .536), 6-minute walk test (384 ± 96 vs 391 ± 97 m; P = .584), or eGFR (52.6 ± 15.3 vs 52.3 ± 18.5 mL • min−1 • 1.73 m−2; P = .700). ConclusionsRDN was associated with reductions in NT-proBNP and 120-minute glucose tolerance test in HF patients 12 months after RDN treatment. There was no deterioration in other indices of cardiac and renal function in this small feasibility study.

Rehabilitation strategies following esophageal cancer (the ReStOre trial): a feasibility study

As survival rates in esophageal cancer improve, the role of rehabilitation programs in this group is emerging as an important issue. This study aims to determine the feasibility of a multidisciplinary rehabilitation program to optimize physical function and quality of life in esophageal cancer survivors. This single-arm feasibility study recruited patients who had completed curative treatment for esophageal cancer, including esophagectomy, with node-negative postsurgical pathology. The multidisciplinary program consisted of 12 weeks of supervised and home-based exercise, dietetic counseling, and education sessions. Feasibility outcomes included recruitment rates, adherence, adverse events, and retention. Other outcomes included cardiopulmonary fitness (maximal cardiopulmonary exercise test and the six minute walking test), quality of life (QOL) (European Organisation for Research and Treatment of Cancer (EORTC) questionnaires) and body composition (bioimpedance analysis). Change in outcomes from baseline to postintervention was measured using the paired sample t-tests. Twelve participants (mean (standard deviation) age 61.4 (7.29) years, eight male) consented to participate, representing a recruitment rate of 55%. Mean class attendance was 82(13)% and mean adherence to the home exercise program was 118(76)%. No adverse events occurred. Retention to the program was 100%. VO2max improved by 3.99(2.7) mL/kg/min (p < 0.004). The six minute walking test distance increased by 56.3(35.3) m (p < 0.003). Global, functional, and symptom QOL scores improved. Body composition remained stable. This pilot study demonstrated high feasibility and acceptability in this complex cohort. Clinically significant improvements in functional performance and QOL were evident without compromise to body composition. The results of this study will help guide the design of a forthcoming larger randomized controlled trial.

Tu1466 Safety and Efficacy of Endobiliary Radiofrequency Ablation by Using a Novel RF Catheter (ELRA®) in Patients With Distal Malignant Biliary Strictures: A Single-Arm Feasibility Study

Tu1466 Safety and Efficacy of Endobiliary Radiofrequency Ablation by Using a Novel RF Catheter (ELRA®) in Patients With Distal Malignant Biliary Strictures: A Single-Arm Feasibility Study

Restoring effective sleep tranquility (REST): A feasibility and pilot study.

IntroductionThe purpose of this pilot study was to establish the feasibility of completing a future controlled trial of a multi-component cognitive behavioral therapy for insomnia program for military veterans with sleep disturbance.MethodThis was a single-arm feasibility and pilot study. Participants were United States post-9/11 veterans with service-connected injuries, university students, and had self-reported sleep disturbances. Restoring Effective Sleep Tranquility was a multi-component cognitive behavioral therapy for insomnia intervention consisting of seven sessions of group therapy and eight 1:1 sessions delivered by occupational therapists. Feasibility and pilot indicators were process, resources, management, and scientific, including pre–post-assessments of sleep difficulties, dysfunctional sleep beliefs, participation, and pain interference.FindingsIndicators were supportive of feasibility, including reduced sleep difficulties (for example Medical Outcomes Study Sleep Measure [t = 3.29, p = .02]), reduced nightmares: t = 2.79, p = .03; fewer dysfunctional sleep beliefs: t = 3.63, p = .01, and greater ability to participate in social roles: t = –2.86, p = .03, along with trends towards improved satisfaction with participation and reduced pain interference.ConclusionThe Restoring Effective Sleep Tranquility program may reduce sleep difficulties and improve participation in US veterans with service-connected injuries, and evidence indicates a controlled trial would be feasible to deliver.

Piloting breast cancer survivorship care planning in a safety net hospital.

65 Background: Survivorship care plans (SCPs) include treatment summaries and follow-up care recommendations intended to improve patient care and well-being after cancer treatment. Limited research has yielded mixed results regarding SCPs' impact on patient and system outcomes, but emphasized provider burden as an implementation barrier. We created a patient-centered SCP template and implemented its delivery at a safety net hospital that serves primarily racial/ethnic minority patients. Methods: In a single-arm feasibility study, oncologists and advanced practice nurses used the template to deliver SCPs to post-treatment breast cancer survivors (BCS) in consultation visits. We assessed changes in patient-reported outcomes from baseline (pre-SCP) to a 3-month follow-up, as well as provider time burden. Results: Female BCS participants (n = 75; mean age = 58.5 years) were primarily African-American (73%) and had high school/GED education or less (61%). Average time since diagnosis was 3.7 years (SD = 3.8); all received surgery; most received radiation (84%), hormone (77%), and/or chemotherapy treatment (73%). At follow-up, a majority rated their SCPs as good to excellent (92%), easy or very easy to understand (84%), a good to excellent summary of their treatment (92%) and as motivation for healthy lifestyles (88%). BCS follow-up scores improved significantly from baseline on breast cancer knowledge (p = .02), self-efficacy (p = .03), the QLQ-INFO25 (p &lt; .01), and the FACIT TS-PS satisfaction with health care staff communication subscale (p &lt; .01). No significant differences between baseline and follow-up scores (p &lt; .05) were found for overall treatment satisfaction, health behaviors, and health-related quality of life. Preparing and delivering SCPs took providers considerable time (M = 54 &amp; 22 minutes, respectively). Conclusions: This pilot study is limited by a single-arm design, but results suggest that SCPs may be related to improved survivor knowledge, information, self-efficacy and communication with health care staff. The individualized, comprehensive SCPs were well received by BCS in a safety net hospital but delivery was time-intensive. These findings will inform future research trials and clinical care initiatives.

A mindful self-compassion videoconference intervention for nationally recruited posttreatment young adult cancer survivors: feasibility, acceptability, and psychosocial outcomes.

Young adult (YA) cancer survivors report substantial distress, social isolation, and body image concerns that can impede successful reintegration into life years after treatment completion. Mindful Self-Compassion (MSC) interventions focus on developing mindfulness and self-compassion for managing distress, hardships, and perceived personal inadequacies. An MSC intervention would be beneficial in supporting YA survivors' management of psychosocial challenges that arise in survivorship; however, a telehealth intervention modality is essential for reaching this geographically dispersed population. We conducted a single-arm feasibility study of an MSC 8-week videoconference intervention for nationally recruited YA survivors (ages 18-29). The MSC intervention was group-based, 90-minute videoconference sessions, held weekly over 8weeks, with audio-supplemented home practice. Feasibility and acceptability were assessed via attendance rate and an intervention satisfaction scale. Baseline to post-intervention changes in psychosocial outcomes (body image, anxiety, depression, social isolation, posttraumatic growth, resilience, self-compassion, mindfulness) were assessed using paired t tests and Cohen's d effect sizes. Thirty-four participants were consented and 25 attended a videoconference group. Feasibility was established with 84% attending at least six of the eight sessions, and intervention acceptability was high (M=4.36, SD=0.40, score range=1-5). All psychosocial outcomes, except for resilience, demonstrated significant changes (p<0.002), with medium to large effect sizes (Cohen's d>0.5). YA survivors are interested in receiving an MSC videoconference intervention. Feasibility, acceptance, and potential psychosocial benefits of the intervention were demonstrated. Findings can be applied toward the design of an efficacy randomized controlled trial to improve quality of life for YA survivors in transition after cancer treatment.

Safety and Effectiveness of Bone Marrow Cell Concentrate in the Treatment of Chronic Critical Limb Ischemia Utilizing a Rapid Point-of-Care System.

Critical limb ischemia (CLI) is the end stage of lower extremity peripheral vascular disease (PVD) in which severe obstruction of blood flow results in ischemic rest pain, ulcers and/or gangrene, and a significant risk of limb loss. This open-label, single-arm feasibility study evaluated the safety and therapeutic effectiveness of autologous bone marrow cell (aBMC) concentrate in revascularization of CLI patients utilizing a rapid point-of-care device. Seventeen (17) no-option CLI patients with ischemic rest pain were enrolled in the study. Single dose of aBMC, prepared utilizing an intraoperative point-of-care device, the Res-Q™ 60 BMC system, was injected intramuscularly into the afflicted limb and patients were followed up at regular intervals for 12 months. A statistically significant improvement in Ankle Brachial Index (ABI), Transcutaneous Oxygen Pressure (TcPO2), mean rest pain and intermittent claudication pain scores, wound/ ulcer healing, and 6-minute walking distance was observed following aBMC treatment. Major amputation-free survival (mAFS) rate and amputation-free rates (AFR) at 12 months were 70.6% and 82.3%, respectively. In conclusion, aBMC injections were well tolerated with improved tissue perfusion, confirming the safety, feasibility, and preliminary effectiveness of aBMC treatment in CLI patients.

The Gestational Diabetes Management System (GooDMomS): development, feasibility and lessons learned from a patient-informed, web-based pregnancy and postpartum lifestyle intervention.

BackgroundGestational diabetes mellitus (GDM) contributes to the epidemic of diabetes and obesity in mothers and their offspring. The primary objective of this pilot study was to: 1) refine the GDM Management System (GooDMomS), a web-based pregnancy and postpartum behavioral intervention and 2) assess the feasibility of the intervention.MethodsIn phase 1, ten semi-structured interviews were conducted with women experiencing current or recent GDM mellitus GDM to garner pilot data on the web based intervention interface, content, and to solicit recommendations from women about refinements to enhance the GooDMomS intervention site. Interviews were audiotaped, transcribed and independently reviewed to identify major themes with Atlas.ti v7.0. In phase 2, a single-arm feasibility study was conducted and 23 participants were enrolled in the GooDMomS program. Participants received web lessons, self-tracking of weight and glucose, automated feedback and access to a message board for peer support. The primary outcome was feasibility, including recruitment and retention and acceptability. Secondary outcomes included the proportion of women whose gestational weight gain (GWG) was within the Institute of Medicine (IOM) guidelines and who were able to return to their pre-pregnancy weight after delivery.ResultsComments from semi-structured interviews focused on: 1) usability of the on-line self-monitoring diary and tracking system, 2) access to a safe, reliable social network for peer support and 3) ability of prenatal clinicians to access the on-line diary for clinical management. Overall, 21 (91 %) completed the pregnancy phase. 15/21 (71 %) of participants were within the Institute of Medicine (IOM) guidelines for GWG. Sixteen (70 %) completed the postpartum phase. 7/16 (43 %) and 9/16 (56 %) of participants returned to their pre-pregnancy weight at 6 and 30 weeks postpartum, respectively.ConclusionsThis study documents the feasibility of the GooDMomS program. The results can have implications for web technology in perinatal care and inform the current care paradigm for women with GDM. Findings are supportive of further research with recruitment of a larger sample of participants and comparison of the outcomes with the intervention and standard care.Trial registrationThe study was registered at ClinicalTrials.gov on May 15, 2012 under protocol no. NCT01600534.