The ENGAGE study: A 3-arm randomized hybrid type 1 effectiveness and implementation study of an in-home, collaborative PCP model of remote telegenetic services to increase uptake of cancer genetic services in childhood cancer survivors

Background: Germline cancer genetic testing has become a standard evidence-based practice, with established risk reduction and screening guidelines for genetic carriers. Access to genetic services is limited in many places, which leaves many genetic carriers unidentified and at risk for late diagnosis of cancers and poor outcomes. This poses a problem for childhood cancer survivors, as this is a population with an increased risk for subsequent malignant neoplasms (SMN) due to cancer therapy or inherited cancer predisposition. The ENGaging and Activating cancer survivors in Genetic services (ENGAGE) study evaluates the effectiveness of an in-home, collaborative PCP model of remote telegenetic services to increase uptake of cancer genetic testing in childhood cancer survivors compared to usual care options for genetic testing. Methods: The ENGAGE study is a 3-arm randomized hybrid type 1 effectiveness and implementation study within the Childhood Cancer Survivor Study population which tests a clinical intervention while gathering information on its delivery during the effectiveness trial and its potential for future implementation among 360 participants. Participants are randomized into three arms. Those randomized to Arm A receive genetic services via videoconferencing, those in Arm B receive these services by phone, and those randomized to Arm C will receive usual care services. Discussion: With many barriers to accessing genetic services, innovative delivery models are needed to address this gap and increase uptake of genetic services. The ENGAGE study evaluates the effectiveness of an adapted model of remote delivery of genetic services to increase the uptake of recommended genetic testing in childhood cancer survivors. This study assesses the uptake in remote genetic services and identify barriers to uptake to inform future recommendations and a theoretically-informed process evaluation which can inform modifications to enhance dissemination beyond this study population and to realize the benefits of precision medicine. Trial registration: This protocol was registered at clinicaltrials.gov (NCT04455698) on July 2, 2020.</p

A randomized, placebo-controlled trial of long-acting dexamethasone viscous gel delivered by transforaminal injection for lumbosacral radicular pain

Epidural steroid injections are used to treat lumbosacral radicular pain. However, there are no Food and Drug Administration–approved corticosteroids for lumbosacral radicular pain and all currently available injectable corticosteroids carry safety warnings about their use in epidural steroid injection procedures. SP-102 (dexamethasone injectable viscous gel) was developed to provide a safer option with extended local effect. In a randomized, double-blind, placebo-controlled, multicenter trial, 401 patients with moderate-to-severe leg pain from unilateral intervertebral lumbar disc herniation were randomized (1:1) to receive transforaminal SP-102 or sham intramuscular (IM) placebo injection and followed for 24 weeks. If clinically warranted, a repeat open-label SP-102 injection was allowed between 4 and 20 weeks for both groups. Primary and key secondary end points were change in average daily pain on the Numeric Pain Rating Scale in the affected leg and disability measured by Oswestry Disability Index over 4 weeks. Other secondary end points included time to repeat injection, pain, and quality of life assessments. Over 4 weeks, SP-102 demonstrated statistically significant pain relief compared with placebo (least-squares mean group difference −0.52 [SE 0.163] [ P = 0.002]) in the intent-to-treat population. Oswestry Disability Index mean improvement was −3.38 (1.388) (least-squares mean group difference [SE]) for SP-102 vs placebo ( P = 0.015). Median time to repeat injection was 84 days for SP-102 vs 58 days for placebo ( P = 0.001). Most other secondary end points were statistically significant for SP-102 compared with placebo. There were no serious adverse events related to study medication or procedure, no adverse events leading to death, and no AEs of special interest (paraplegia, hematoma, or infection)