Prospective Single-arm Pilot Study Research Articles

A Pilot Study of Omalizumab to Treat Severe Allergic Asthma in South Indian Population

Background: Asthma is a respiratory disease that affects your lungs. In asthma, airways of the lungs constrict due to swelling and accumulation of mucus. Newer remedies known as targeted therapies have evolved as a result of advancements in medical research, greatly relieving these patients. The biologics used in the severe allergic asthma is Omalizumab.
 Purpose: Demonstrating the clinical efficacy of Omalizumab in severe allergic asthma by reducing exacerbation rates and increasing quality of life.
 Methods: A single-arm prospective pilot study of omalizumab in severe allergic asthma was conducted in a tertiary care hospital for the duration of one year with the help of Asthma Quality of Life Questionnaire (AQLQ).
 Results and discussions: On an initial dose of omalizumab of 150 mg in 2 vials subcutaneously every month for 6 months, among our study population, 45% of the patients had their symptoms improve more than they had with prior medications. Results show that the patient's overall score has improved by nearly 50%. This shows that omalizumab improves the quality of life of severe asthmatic patients.
 Conclusion: Patients treated with omalizumab have improved their clinical conditions and quality of life, and it can prevent exacerbations by controlling the severity of the condition.
 Keywords: AQLQ, Allergic asthma, Exacerbation, IgE, Omalizumab.

Evaluation of Tumor Grade and Proliferation Indices before and after Short-Course Anti-Inflammatory Prednisone Therapy in Canine Cutaneous Mast Cell Tumors: A Pilot Study.

Glucocorticoid administration is a common clinical practice that attempts to decrease the inflammation associated with and improve the resectability of canine mast cell tumors (MCTs). However, the impact of neoadjuvant glucocorticoids on the histological features and proliferation indices of canine MCTs is unknown. The objective of this study was to evaluate changes in tumor grade, mitotic count, Ki67, AgNOR, and AgNORxKi67 scores following short-course anti-inflammatory neoadjuvant prednisone in canine patients with MCTs. This was a prospective single-arm pilot study. Client-owned dogs with treatment-naïve cytologically confirmed MCTs were enrolled. Patients underwent an initial incisional biopsy followed by a 10–14-day course of anti-inflammatory prednisone and surgical resection. All histological samples were randomized, masked, and evaluated by a single pathologist. Unstained paired pre- and post-treatment samples were submitted to a commercial laboratory for Ki67 and AgNOR immunohistochemical analysis. There were 11 dogs enrolled with 11 tumors. There were no statistical differences between the pre- and post-treatment histological parameters of mitotic index, Ki67, AgNOR, or Ki67xAgNOR. There were no clinically significant alterations between pre-treatment and post-treatment in the assignment of tumor grades. A short course of anti-inflammatory prednisone does not appear to alter the histological parameters that affect grade determination or significantly alter the proliferation indices in canine MCTs.

Barriers and enablers for older adults participating in a home-based pragmatic exercise program delivered and monitored by Amazon Alexa: a qualitative study

BackgroundThe remote delivery and monitoring of individually-tailored exercise programs using voice-controlled intelligent personal assistants (VIPAs) that support conversation-based interactions may be an acceptable alternative model of digital health delivery for older adults. The aim of this study was to evaluate the enablers and barriers for older adults participating in a home-based exercise program delivered and monitored by VIPAs.MethodThis qualitative study used videoconferencing to conduct semi-structured interviews following a 12-week, prospective single-arm pilot study in 15 adults aged 60 to 89 years living alone in the community. All participants were prescribed an individualized, brief (10 min, 2–4 times per day), home-based muscle strengthening and balance exercise program delivered and monitored using an Amazon Echo Show 5 device (Alexa). Qualitative interview data were analysed using inductive thematic analysis.ResultsAll 15 participants (aged 70.3 ± 4.3 years, mean ± SD) attended the semi-structured interview. Themes including enjoyability and ease of use, social engagement and motivation were enablers for participation in the exercise program. Errors in voice recognition, lack of feedback, and preference for other existing digital health modes of exercise delivery were barriers associated with the Alexa technology.ConclusionsThis qualitative study identified enablers and barriers associated with using an Alexa device to deliver and monitor an individualized, home-based exercise program in older adults living alone. Future interventions using VIPAs should focus on reducing technical errors, providing regular exercise feedback, and comparing participants’ experiences of exercise programs delivered by VIPAs to programs delivered via other digital health tools.

Microwave ablation via a flexible catheter for the treatment of nonsurgical peripheral lung cancer: A pilot study.

BackgroundEndobronchial microwave ablation via flexible catheter offers the potential for local therapy for inoperable peripheral lung cancer. The study aimed to evaluate the feasibility and safety of navigation bronchoscopy‐guided water‐cooled microwave ablation catheter for nonsurgical peripheral lung cancer.MethodsThis was a prospective single arm pilot study. Patients with early stage or multiple primary peripheral lung cancer who were nonsurgical candidates for surgery were enrolled in the study. Bronchoscopic microwave ablation was performed via a flexible water‐cooled microwave ablation antenna under the guidance of navigation bronchoscopy. Radial probe endobronchial ultrasound combined with fluoroscopy was used to confirm the position. Treatment outcomes were evaluated based on follow‐up chest CT and positron emission tomography scans. Primary endpoints were technical success and safety. Secondary endpoints were complete ablation rate, 2‐year local control rate, and progression‐free survival.ResultsThirteen patients were enrolled in the study from April 2018 to July 2019. A total of 19 sessions of microwave ablation were performed on 14 tumors under the guidance of navigation bronchoscopy. The technical success was 100%. Treatment‐related complications occurred in two patients. The complete ablation rate was 78.6% (11/14). The 2‐year local control rate was 71.4%. Median progression‐free survival was 33 months for all patients.ConclusionsIn this pilot study, bronchoscopic microwave ablation appears to be feasible with acceptable occurrence of complication in the treatment of peripheral lung cancer under the guidance of navigation bronchoscopy.

A Pilot Study of Omalizumab to Treat Oxaliplatin-Induced Hypersensitivity Reaction.

Oxaliplatin hypersensitivity reactions (HSRs) are immunoglobulin E (IgE)-mediated and prevent maximum benefit from this drug. This study was designed to determine whether oxaliplatin HSRs could be prevented or reduced with omalizumab (Xolair), an anti-IgE antibody. This was a single-arm prospective pilot study. Patients receiving oxaliplatin-based chemotherapy for gastrointestinal cancers who were experiencing grade 1/2 HSRs were eligible. Patients received omalizumab 300 mg subcutaneously every 2 weeks, alternating with oxaliplatin-based chemotherapy. Nine patients enrolled. The primary end point was reduction of repeat HSR over the next 2 cycles. The sample size of 12 patients would achieve 79% power to detect a decrease from HSR rate of 70% (the null hypothesis) to 35% using a 1-sided binomial test. The study would be considered positive if fewer than 6 HSR events over 2 cycles occurred on omalizumab. Nine patients received 58 cycles of omalizumab. The mean number of treatments was 6 (range, 1-12). Eight of 9 patients (88%) completed 2 or more cycles and 7 (78%) completed 4 or more cycles; the overall rate of HSR was 12%. Five of 7 evaluable patients had stable disease, including 1 with near partial response. Omalizumab reduces or abrogates oxaliplatin HSRs and allows months of additional therapy with apparent clinical benefit.

Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM)

IntroductionNipple-sparing mastectomy (NSM) can be performed for the treatment of breast cancer and risk reduction, but total mammary glandular excision in NSM can be technically challenging. Minimally invasive robot-assisted NSM...

Colorectal Cancer and Polyp Detection Using a New Preparation-Free, Colon-Scan Capsule: A Pilot Study of Safety and Patient Satisfaction.

Current strategies to prevent colorectal cancer (CRC) vary considerably regarding safety, invasiveness, and patient satisfaction. A known deterrent for patients is the required bowel cleansing for colonoscopy. A new colon-scan capsule system is a unique preparation-free approach that provides structural information on colonic mucosa intended for detection of colorectal polyps and masses. The aim of this study was to determine safety and patient satisfaction with the colon-scan capsule. Prospective single-arm pilot study conducted at two tertiary care centers. Patients with a pre-scheduled colonoscopy for CRC screening or surveillance were included. Patients participating in this study underwent the colon-scan capsule and colonoscopy. Safety was defined by the occurrence of procedure or device-related adverse events. Satisfaction was based on survey questionnaires using a scoring system 1 (strongly disagree) to 5 (strongly agree). Patient satisfaction with the colon-scan capsule was compared to colonoscopy. Forty patients were included (52.9 [5.7] years; 64.1% females). There were no serious adverse events and no occurrences of capsule retention. The most common (12.5%) complaint was self-limiting abdominal cramping. Satisfaction questionnaires were completed by more than 87% of patients, with patients likely to recommend the capsule (score 4.1 [1.03]) compared to colonoscopy (score 2.8 [1.2]), p = 0.001. The new prepless colon-scan capsule system is an innovative, minimally invasive technology with demonstrated safety and high patient satisfaction. A multicenter pivotal study is planned to validate the performance, safety, and accuracy of polyp detection using the capsule system in comparison with colonoscopy.

Patient responses to weekly electronic patient-reported outcomes.

182 Background: Home-based symptom monitoring using patient reported outcomes has been shown to reduce symptom burden and hospitalizations, while improving quality of life and overall. The primary goal of this study was to evaluate the early feasibility of home-based symptom monitoring. Methods: This prospective single-arm pilot study evaluated a two-part education and technology intervention (home-based symptom monitoring) for clinicians treating Multiple Myeloma (MM) and Acute Myeloid Leukemia (AML) patients. Inclusion criteria included patients ≥ 60 who were anticipating a treatment decision. Participants completed a baseline survey and then enrolled into the PROmpt® symptom monitoring platform, which used text or email to prompt weekly symptom surveys. Patients receive an auto-generated self-management plan based on electronic patient reported outcomes (ePRO). If severe symptoms were reported (score of > 7/10), alerts were sent to clinical nurses. Outcomes for this study included proportion of patient approach who agreed to participate, patient completion rates (completion of weekly surveys), compliance rate (completion of total surveys), number of alerts generated, and type of alert. Feasibility was defined as a completion rate of > 70%. Results: Between September 1, 2020 –May 19, 2021; 114 patients were screened, 77 were approached, and 35 were enrolled (18) MM, (17) AML patients. Of non-participants, 11 were not seeking care at the institution, 10 patients were uninterested or did not have a smartphone, 9 patients were ineligible, and 9 were unsure and left with information about the study, 3 declined enrollment. The majority (80%) or participants were ages 60-74; 20% of patients were ages 75+. Over the 13-week period, AML patients completed 195/220 (compliance rate of 89%). The average completion rate was 92%. For MM, 192/233 surveys were completed (82% compliance rate). The average completion rate was 94%. For AML, 9 was the average number of completed surveys and the average number for MM was 8. Over 3 months, there were 294 moderate to severe alerts generated for AML and MM patients. For AML patients, there were 40 fatigue, 25 constipation, 21 pain, 17 decreased appetite, 11 insomnia, 11 rash, 6 anxiety, 7 dyspnea/cough, 7 diarrhea, 5 depression/sadness, 4 nausea/ vomiting, 4 mouth/ throat sores, 3 neuropathy, 3 fever, and 2 alerts for other symptoms. Within a 3 month time span for MM patients, there was 35 pain, 21 constipation, 18 fatigue, 11 rash, 10 neuropathy, 9 anxiety, 7 insomnia, 6 depression/sadness, 4 decreased appetite, 4 other symptom, and 1 nausea/vomiting alert. Conclusions: This study demonstrated early feasibility with over 80% of patient completing their surveys with a high compliance rate. Future analysis will include both final implementation outcomes as well as patient outcomes for all patients within the study.

Barriers to patient-centered oncology care: Pilot study of home infusion of anticancer immunotherapy.

36 Background: ASCO published a position statement regarding home infusion of anticancer therapy in June 2020. This statement recommends independent research to evaluate the safety and effectiveness of home infusions. Intermountain Healthcare (IM) incorporated this statement into its oncology care with an IRB-approved, prospective single-arm pilot study to determine the safety and feasibility of home administration of checkpoint inhibitor (CPI) immunotherapy with synchronous telemedicine visits. Methods: Patients with cancer receiving treatment at Intermountain Medical Center and Intermountain Cancer Center St. George were screened for enrollment into an IRB-approved, non-randomized pilot study of 20 patients. Eligibility criteria required patients to receive a CPI for an FDA-approved indication, live in Washington County or Salt Lake County, Utah, and have commercial payer coverage of CPI home infusion. Eligible patients were required to receive 2 doses of CPI at an infusion center, and patients who experienced an infusion reaction were excluded from receiving home infusion. Home infusion nurses are trained in oncology, CPIs, and home infusion reaction protocol. During synchronous video visits, infusion nurses are trained to perform the hands-on portions of the physical exam. A financial analysis estimated cost to IM and commercial payers for routine and home CPI infusions. Results: 622 patients were screened, of which 104 were receiving a CPI. 64 patients lived in an eligible county and 19 patients had commercial payer coverage. Of patients on CPIs, 8.7% (9/104) met all eligibility criteria accounting for 1.4% (9/622) of all patients with cancer screened (Table). Financial analysis estimated $829 cost (excluding drug cost) to IM for standard infusion reimbursement compared to $599 for in-home CPI infusions, accounting for savings of $230 per infusion. Majority of cost savings are from elimination of infusion center facilities fee ($495). Analysis includes $269 for home infusion nurse wages. Subsequent analysis for commercial payer SelectHealth estimates $270 reimbursement savings for the payer. Conclusions: Home immunotherapy infusions are estimated to be cost effective for both IM and commercial payers. However, lack of drug coverage and the rural demographics of Utahns with cancer are barriers to home CPI infusions. The pilot study was discontinued per infeasibility stopping criteria.[Table: see text]

Use of the helical SUPERA™ stent and Passeo-18 Lux™ drug-coated balloon to treat recurrent cephalic arch stenosis for dysfunctional brachiocephalic fistulas: 1 year results of the Arch V SUPERA-LUX study.

Aim of Arch V SUPERA-LUX was to evaluate the safety and efficacy of the combination therapy of SUPERA™ (Abbott Vascular, Santa Clara, CA, USA) helical stent implantation and Passeo-18 Lux™ (Biotronik Asia Pacific Pte Ltd, Singapore) drug coated balloon (DCB) elution to treat recurrent cephalic arch stenosis (CAS) in the setting of AV access dysfunction. Investigator-initiated, single-center, single-arm prospective pilot study of 20 end-stage renal failure Asian patients with a dysfunctional brachiocephalic fistula. All had symptomatic recurrent CAS within 6 months of prior intervention. The lesion was pre-dilated with a standard high-pressure balloon (Biotronik Passeo-35 HP balloon). The DCB (Passeo-18 Lux™) is subsequently inflated and the SUPERA™ stent deployed to sit 2 mm distal to the cephalic arch and covering the CAS but within the DCB zone. All patients were prescribed dual antiplatelet therapy for 3 months and followed up with Duplex ultrasound at 6- and 12-months. There were 9 (45%) males and mean age was 67 ± 11.0 years. Mean time from prior procedure was 113 ± 68 days and main indication for reintervention was high venous pressure (9/20, 45%). Technical success was 100% and there were no peri-procedural complications related to either stent or DCB deployment. Target lesion primary patency at 6- and 12-months was 10/18 (55%) and 5/16 (31%), respectively. Mean time to target lesion re-intervention was 170 ± 82 days. Circuit access patency was 8/18 (44%) and 2/16 (13%) at 6- and 12-months respectively and mortality was 3/20 (15%) attributed to the patients' underlying co-morbidities. Dual prong strategy of using SUPERA™ stenting and Passeo-18 Lux™ drug elution for recurrent CAS, although safe, was no more efficacious than conventional balloon angioplasty or stenting alone. Development of an intense inflammatory reaction within the stent led to reinterventions of a number of cases with suboptimal results.

Utility of 18F-Fluciclovine PET/MRI for Staging Newly Diagnosed High-Risk Prostate Cancer and Evaluating Response to Initial Androgen Deprivation Therapy: A Prospective Single-Arm Pilot Study.

BACKGROUND. Despite advances in prostate cancer treatment, rates of biochemical recurrence remain high, relating to lack of detection of small-volume metastatic disease using conventional imaging for initial staging. OBJECTIVE. The purpose of this study was to assess the potential use of 18F-fluciclovine PET/MRI for initial staging of high-risk prostate cancer and evaluating response to androgen deprivation therapy (ADT). METHODS. This prospective clinical trial enrolled 14 men with newly diagnosed high-risk prostate cancer and negative or equivocal conventional staging imaging for metastatic disease between January 2018 and February 2019. All patients underwent pretreatment 18F-fluciclovine PET/MRI including multiparametric prostate MRI; 12 underwent 18F-fluciclovine PET/MRI after surgery or between ADT and radiotherapy. Confidence in identification of the primary intraprostatic lesion and nodal metastases was independently rated on a 0-3 Likert scale by three readers with nuclear medicine experience for 18F-fluciclovine PET/MRI and three readers with abdominal imaging experience for MRI alone. Findings scored as 2 or 3 by at least two readers of a given modality were considered positive. A single reader measured SUVmean, SUVmax, and volume of the MRI-defined intraprostatic lesion and SUVmax of suspicious lymph nodes on PET before and after initiation of ADT. Changes in SUV were analyzed using nonparametric Wilcox-on signed-rank tests. RESULTS. The biopsy-proven lesion in the prostate gland was accurately identified in all 14 patients on both MRI and 18F-fluciclovine PET/MRI. Suspected nodal metastases were detected in three patients on MRI and seven patients on 18F-fluciclovine PET/MRI. After ADT, all patients showed decreased activity within the intraprostatic lesion and/or all suspicious lymph nodes. The primary lesion SUVmean was 4.5 ± 1.1 (range, 2.7-6.5) before treatment and 2.4 ± 1.1 (range, 0.0-3.6) after initiation of ADT (p = .008). For suspicious lymph nodes, the pretreatment SUVmax was 5.5 ± 3.7 (range, 2.8-12.7) and the post-treatment SUVmax was 2.8 ± 1.4 (range, 1.4-5.5) (p = .03). CONCLUSION.18F-labeled fluciclovine PET/MRI shows potential utility in initial staging of high-risk prostate cancer and in evaluating response to ADT. CLINICAL IMPACT. Given the FDA approval and widespread availability of 18F-fluciclovine, the findings could have an impact in the immediate future in guiding initial management of patients with prostate cancer. TRIAL REGISTRATION. ClinicalTrials.gov NCT03264456.

Safety and tolerability of subcutaneous trastuzumab and intravenous pertuzumab as adjuvant treatment for HER2 positive breast cancer: a pilot study

BackgroundSubcutaneous (SC) trastuzumab is similar to intravenous trastuzumab in terms of pharmacokinetics, efficacy and tolerability. The use of dual anti-HER2 agents trastuzumab and pertuzumab has become the new standard for...

Primary care oncology model (PCOM): Implementation of a model integrating primary and oncology care for patients taking oral anticancer agents.

TPS1587 Background: Non-adherence to oral anticancer agents (OAA) has been reported among 30% of individuals. Often, individuals with cancer are not just managing their new OAA but also medications to treat multiple chronic conditions (MCC). Multiple factors contribute to the extent patients on OAAs and MCC medications adhere to therapy. The objective of this study is to improve medication, symptom, and disease management of patients with hematological malignancies and MCC through care coordination between pharmacists. Methods: Design. This is a multi-center prospective single arm pilot study at two academic medical centers in Michigan and Tennessee. Subjects. Ninety participants will be recruited, 60 from site 1 and 30 from site 2. Inclusion criteria are: adults > 18 years, diagnosed with and initiating oral treatment for chronic myeloid leukemia, chronic lymphocytic leukemia, or multiple myeloma, diagnoses of at least 2 chronic conditions, where one is type 2 diabetes, hypertension, congestive heart failure, depression/anxiety, gastroesophageal reflux disease, hyperlipidemia, or chronic obstructive pulmonary disease, taking at least two chronic medications, and able to provide electronic consent. Exclusion criteria are: inability to speak English, and diagnosis of type 1 diabetes or HIV. Intervention. Participants will complete two Patient Reported Outcome Measures (PROMs) for their OAA that will be reviewed by the oncology pharmacist, with follow-up to the care team if needed. Participants will be scheduled for a Comprehensive Medication Review with a primary care pharmacist for up to two visits for their chronic medications. The intervention over 2 months, and the oncology and primary care pharmacists communicate via electronic health record about medications, symptoms, and disease control. Outcomes. The primary endpoints are (a) dose-adjusted adherence by proportion days covered (PDC) for the OAA and (b) PDC for chronic condition medications, assessed using 6 months of prescription claims. Data will be collected from patients using REDCap surveys and abstracted data will be entered into REDCap. Implementation by pharmacists and patient acceptability will be examined. Analysis. The association of OAA and chronic medication adherence (PDC) will be examined via correlation. Participant demographics,clinical characteristics, and the symptom experience from the PROM will be described. Using CMR results, medication problems, recommendations, and changes will be provided. Program implementation will be assessed and patient perceptions obtained from post-CMR interviews. A joint display for the quantitative and qualitative data for feasibility, appropriateness, and acceptability from pharmacists will be completed. Results: Screening and recruitment has begun. Clinical trial information: NCT04595851 and NCT04663100.

Conversion hepatectomy for hepatocellular carcinoma with inadequate future- remnant- liver after portal vein ligation in combination with apatinib plus camrelizimab: A single-arm prospective pilot study (PLACES).

e16132 Background: A variety of staged hepatic resection has been applied in patients (pts) with hepatocellular carcinoma (HCC) who had an inadequate future-remnant-liver (FRL), but the clinical outcomes remain unsatisfactory. Based on the clinical data of apatinib (a highly selective VEGFR-2 inhibitor) and camrelizimab (anti‐PD‐1 antibody) in HCC pts, we therefore evaluated the safety and efficacy of portal vein ligation (PVL) in combination with apatinib plus camrelizimab for primary HCC with insufficient residual liver volume. Methods: Pts aged 18-75, with HCC, Child-Pugh A status, BCLC stage A-C, preoperative indocyanine green retention rate at 15 min < 10%, and preoperative FLR/standardized liver volume (SLV) < 30% (for pts without cirrhosis ) and < 40% (for pts with cirrhosis ) were enrolled. Pts received PVL followed by camrelizimab (200mg, iv, d1 q2w) plus apatinib (250mg, po, pd, q2w) until surgical criteria were met. Pts underwent second-stage hepatic resection 4 weeks after treatment discontinuation, and continued treatment with apatinib plus camrelizimab for 1 year or endpoints occurred. The primary endpoints were resection rate of conversion surgery and ORR (objective response rate). Results: Between Apr 21, 2020 to Jan 20, 2021, 14 pts were enrolled in this trial. The estimated median preoperative FLR/SLV for all pts was 34.6%. Among the 10 evaluable pts, 7 met the criteria for surgery and 5 completed second-stage hepatectomy except for 2 pt who refused and waited for surgery, respectively. The median interval time of the two stages of surgery was 138.8 days. ORR was 40%, and disease control rate (DCR) was 100% (4 pts with partial response and 6 pts with stable disease). The other 4 pts are waiting for the evaluation. No adverse events (AEs) of grade 3 or worse occurred after PVL. The most common treatment-related AEs in pts during treatment with apatinib plus camrelizimab included hypoalbuminemia (36%), increased aspartate aminotransferase (AST) (100%) and rash (29%). Major AEs in pts underoing second-stage hepatectomy were pneumonia (100%), increased AST (100%), increased alanine transaminase (100%) and anemia (100%). One patient died of postoperative pulmonary infection. Conclusions: PVL in combination with apatinib plus camrelizimab followed by staged resection may be a safe and effective treatment option for HCC pts with insufficient FLR. Clinical trial information: ChiCTR2000033692.

A pilot study of a yoga intervention for the treatment of anxiety in young people with early psychosis.

Anxiety is common in young people with early psychosis and treatment options for this co-morbidity remain limited. Yoga is a promising adjunct intervention that has been shown to reduce anxiety for adults with schizophrenia, therefore this pilot study evaluated the acceptability and potential effectiveness of yoga for anxiety in early psychosis. A prospective single arm pilot study of a yoga intervention was conducted within an Early Intervention for psychosis service. Rates of attendance, as well as symptoms of anxiety pre and post yoga session were measured. A total of 14 young people participated in the study and over 70% attended half or more of the yoga sessions offered. Significant transient reduction in state anxiety after a single session of yoga was observed (p < 0.01). Yoga was found to be an acceptable and potentially effective adjunctive treatment for anxiety in early psychosis and the results warrant further clinical trials.

Use of Robotic Assistance to Reduce Proximity and air-sharing During Percutaneous Cardiovascular Intervention

Aim: Traditional percutaneous cardiovascular interventions require close physical proximity between the patients and the healthcare team, posing occupational hazards that range from radiation exposure to interpersonal air contamination. Materials & methods: Prospective single-arm pilot study (n=10) to investigate robotic-assisted intervention as a strategy to reduce proximity during the procedure. Primary end point: composite of angiographic success, intervention performed with the team positioned >2meters from the patient for ≥50% procedure duration, and absence of in-hospital death or acute target lesion occlusion. Results: The composite primary end point was achieved in 100% of cases. Conclusion: Robotic-assisted percutaneous intervention provided successful invasive treatment while reducing proximity and shared air space between the care-delivery team and the patient during the procedure. Trial registration number: NCT04379453 (Clinicaltrials.gov).

A Mobile Patient-Facing App for Tracking Patient-Reported Outcomes in Head and Neck Cancer Survivors: Single-Arm Feasibility Study.

BackgroundPatients with head and neck cancer (HNC) frequently experience disease-related symptoms and treatment adverse effects that impact their overall quality of life. Cancer-specific mobile health apps for patient-related outcomes allow patients to communicate with their clinicians and proactively track their symptoms, which have been shown to improve clinical management and disease outcomes.ObjectiveThe purpose of this study was to evaluate the feasibility of LogPAL, a novel iPhone-based mobile health app designed to help HNC survivors track and manage their posttreatment symptoms.MethodsPatients who completed curative treatment for HNC in the preceding 24 months were recruited from 2 clinical sites within a single institution. Upon enrollment, participants completed a brief sociodemographic survey, downloaded the app onto their iPhone devices, and were asked to complete a series of biweekly questionnaires (based on the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events) via the app for an 8-week study period. The primary feasibility endpoints included retention (retaining >80% of the enrolled participants for the duration of the study period), adherence (>50% of the participants completing 100% of the questionnaires over the study period), and usability (a mean system usability scale [SUS] score >68). Additional postintervention questions were collected to assess perceived usefulness, acceptance, and overall satisfaction.ResultsBetween January and October 2019, 38 participants were enrolled in the study. Three participants dropped out, and 3 were classified as nonusers. The remaining 32 (87%) were eligible for analysis. Their mean age was 57.8 (SD 12.3) years (range 24-77 years, 81% [26/32] male). Overall, 375 of 512 (73.2%) questionnaires were completed, with 17 (53%) of the 32 participants adherent. Participant-reported usability was acceptable; the mean SUS score was 71.9 (95% CI 64.3-79.5) with high satisfaction of LogPAL usefulness and likelihood to recommend to other cancer survivors.ConclusionsThis single-arm prospective pilot study showed that LogPAL is a feasible, regularly used, accepted app for HNC survivors, justifying a full-scale pilot. Based on the findings from this study, future iterations will aim to improve usability and test intervention efficacy.

Feasibility, Usability, and Enjoyment of a Home-Based Exercise Program Delivered via an Exercise App for Musculoskeletal Health in Community-Dwelling Older Adults: Short-term Prospective Pilot Study.

BackgroundMany older adults choose and prefer to exercise at home, but to attain the greatest benefits, the correct type and dose of exercise should be prescribed and adherence maintained. Advances in digital health technologies now provide the opportunity for exercise professionals to deliver and monitor personalized, evidence-based exercise programs to anyone at any time.ObjectiveThe aim of this study was to evaluate the feasibility, usability, and enjoyment of a web-based exercise prescription app as a platform for exercise professionals to remotely deliver and monitor an individually tailored, home-based multicomponent exercise program (delivered through tablet computers) to older adults living independently in the community.MethodsThis was an 8-week, prospective single-arm pilot study in 20 adults aged ≥65 years living independently in the community: 10 owned a tablet computer (tablet owners) and 10 did not own tablets (tablet nonowners). All participants were prescribed a home-based, muscle strengthening, weight-bearing impact and challenging balance/mobility program (3 days/week) using a commercial exercise prescription app on a tablet computer. Study endpoints were feasibility (retention, adherence, adverse events), usability (System Usability Scale), physical activity enjoyment (Physical Activity Enjoyment Scale), changes in lower extremity function (Short Physical Performance Battery [SPPB]), and level of physical activity (questionnaire). Process measures related to the participants' experiences and perceptions of the exercise program and web-based app were also included.ResultsA total of 19 participants (mean age, 70 years) completed the study (19/20, 95%), and mean adherence to the exercise program was 84% (95% CI 70%-97%). There were 2 minor adverse events in 2 participants from 401 completed sessions. Mean weekly walking time increased by 78 minutes (95% CI 0-156, P=.049) and moderate-to-vigorous physical activity time by 41 minutes (95% CI –8 to 90, P=.09). For SPPB scores, there was a 0.3 point (95% CI –0.1 to 0.7, P=.17) modest sized (effect size, d=0.42) improvement after 8 weeks. Mean (SD) system usability was high (86 [10] with 100 best imaginable). There was no change in the overall physical activity enjoyment scores after 8 weeks, but participants reported that they enjoyed using the web-based exercise app and the exercise program (median score 4 on a 5-point Likert scale). For all measures, there were no differences between previous tablet owners and nonowners.ConclusionsThis pilot feasibility study indicates that it is safe and feasible for community-dwelling older adults to participate in a home-based, multicomponent exercise program targeting musculoskeletal health and function that was delivered and monitored remotely by exercise professionals using a tablet-based exercise prescription app.

A Single Arm Prospective Pilot Study Examining the Efficacy and Safety of Bevacizumab Single Maintenance Therapy Following Platinum-Based Chemotherapy in Patients with Advanced or Recurrent Cervical Cancer.

Although the addition of bevacizumab to platinum-based combination chemotherapy has been recommended as a standard regimen for patients with advanced or recurrent cervical cancer, there is no clear evidence regarding the effectiveness of bevacizumab monotherapy as salvage chemotherapy. This study prospectively examined the efficacy and safety of switching from platinum-based chemotherapy combined with bevacizumab to single maintenance therapy in patients with advanced or recurrent cervical cancer. Patients were first treated with standard combination chemotherapy. However, if chemotherapy was discontinued because of an adverse event, bevacizumab monotherapy was continued for patients who agreed to participate in this study and provided written informed consent. The study protocol was approved by the Independent Review Board of Tohoku University School of Medicine (reception number 2017-1-540). A total of 15 patients (median age of 55 years, range 33-69 years) participated in this study. The median number of cycles of bevacizumab single maintenance administration was 8, and the main reasons for discontinuation were disease progression and adverse events. Bevacizumab single maintenance therapy had a disease control rate of 53.3% (CR 40%, PR 6.7%, SD 6.7%). The most frequent grade 3/4 clinical adverse events were proteinuria (5/15) and hypertension (4/15). No treatment-related deaths occurred. Bevacizumab single maintenance therapy was effective as salvage chemotherapy in patients with advanced or recurrent cervical cancer, and the safety profile was generally consistent with those reported in previous studies of bevacizumab monotherapy.

An Assessment of Combination of the Camrelizumab With Chemotherapy in Metastatic Biliary Tract Cancers.

Background:Monoclonal antibodies that target the PD-1 receptor are emerging as promising therapeutic candidates for the treatment of biliary tract cancers (BTCs). The purpose of the current study was to assess the combination of the camrelizumab with chemotherapy as a first-line treatment for metastatic BTCs.Methods:We conducted a prospective single-arm pilot study of PD-1 antibody (camrelizumab 3 mg/kg d1, Q2 W or Q3 W) combined with different chemotherapy regimens as first-line treatment for BTCs. Efficacy endpoints were objective response rate (ORR), disease control rate (DCR), progression free survival (PFS), and overall survival (OS). Treatment-related adverse events (TRAEs) were also evaluated.Results:Fourteen patients with histologically confirmed BTCs were evaluated. The ORR was 14.3% (95% CI: 1.8 to 42.8) and the DCR was 64.3% (95%CI: 41.7 to 86.9). The median PFS was 6.5 months (95% CI: 3.8 to 9.2), and the 6- and 12-month PFS rates were 61.6% and 12.3%, respectively. The median OS was 9.9 months (95% CI: 7.6 to 12.2), and the 6-and 12-month OS rates were 74.5% and 26.6%, respectively. All patients displayed at least 1 TRAE., and Grade 3 or 4 TRAEs occurred in 6 (42.86%) patients.Conclusions:Camrelizumab combined with chemotherapy as first-line treatment for metastatic BTCs demonstrated acceptable safety and efficacy in our pilot study. These findings warrant prospective controlled clinical trials comparing combinations of camrelizumab and chemotherapy to standard regimens.