CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: Two concurrent blinded randomized controlled trials

Background: CommunityRx is an evidence-based social care intervention delivered to family and friend caregivers (“caregivers”) at the point of healthcare to address health-related social risks (HRSRs). Two CommunityRx randomized controlled trials (RCTs) are being fielded concurrently on Chicago’s South Side, a predominantly African American/Black community. CommunityRx-Hunger is a double-blind RCT enrolling caregivers of hospitalized children. CommunityRx-Dementia is a single-blind RCT enrolling caregivers of community-residing people with dementia. RCTs with caregivers face recruitment barriers, including caregiver burden and lack of systematic strategies to identify caregivers in clinical settings. COVID-19 pandemic-related visitor restrictions exacerbated these barriers and prompted the need for iteration of the protocols from in-person to remote operations. This study describes these protocols and methods used for successful iteration to overcome barriers. Methods and findings: CommunityRx uses individual-level data to generate personalized, local community resource referrals for basic, health and caregiving needs. In early 2020, two in-person RCT protocols were pre-tested. In March 2020, when pandemic conditions prohibited face-to-face clinical enrollment, both protocols were iterated to efficient, caregiver-centered remote operations. Iterations were enabled in part by the Automated Randomized Controlled Trial Information-Communication System (ARCTICS), a trial management system innovation engineered to integrate the data collection database (REDCap) with community resource referral (NowPow) and SMS texting (Mosio) platforms. Enabled by engaged Community Advisory Boards and ARCTICS, both RCTs quickly adapted to remote operations. To accommodate these adaptations, launch was delayed until November (CommunityRx-Hunger) and December (CommunityRx-Dementia) 2020. Despite the delay, 65% of all planned participants (CommunityRx-Hunger n = 417/640; CommunityRx-Dementia n = 222/344) were enrolled by December 2021, halfway through our projected enrollment timeline. Both trials enrolled 13% more participants in the first 12 months than originally projected for in-person enrollment. Discussion: Our asset-based, community-engaged approach combined with widely accessible institutional and commercial information technologies facilitated rapid migration of in-person trials to remote operations. Remote or hybrid RCT designs for social care interventions may be a viable, scalable alternative to in-person recruitment and intervention delivery protocols, particularly for caregivers and other groups that are under-represented in traditional health services research. Trial registration: ClinicalTrials.gov: CommunityRx-Hunger (NCT04171999, 11/21/2019); CommunityRx for Caregivers (NCT04146545, 10/31/2019).</p

Absolute oxygen-guided radiation therapy improves tumor control in three preclinical tumor models

BackgroundClinical attempts to find benefit from specifically targeting and boosting resistant hypoxic tumor subvolumes have been promising but inconclusive. While a first preclinical murine tumor type showed significant improved control with hypoxic tumor boosts, a more thorough investigation of efficacy from boosting hypoxic subvolumes defined by electron paramagnetic resonance oxygen imaging (EPROI) is necessary. The present study confirms improved hypoxic tumor control results in three different tumor types using a clonogenic assay and explores potential confounding experimental conditions.Materials and methodsThree murine tumor models were used for multi-modal imaging and radiotherapy: MCa-4 mammary adenocarcinomas, SCC7 squamous cell carcinomas, and FSa fibrosarcomas. Registered T2-weighted MRI tumor boundaries, hypoxia defined by EPROI as pO2 ≤ 10 mmHg, and X-RAD 225Cx CT boost boundaries were obtained for all animals. 13 Gy boosts were directed to hypoxic or equal-integral-volume oxygenated tumor regions and monitored for regrowth. Kaplan–Meier survival analysis was used to assess local tumor control probability (LTCP). The Cox proportional hazards model was used to assess the hazard ratio of tumor progression of Hypoxic Boost vs. Oxygenated Boost for each tumor type controlling for experimental confounding variables such as EPROI radiofrequency, tumor volume, hypoxic fraction, and delay between imaging and radiation treatment.ResultsAn overall significant increase in LTCP from Hypoxia Boost vs. Oxygenated Boost treatments was observed in the full group of three tumor types (p &lt; 0.0001). The effects of tumor volume and hypoxic fraction on LTCP were dependent on tumor type. The delay between imaging and boost treatments did not have a significant effect on LTCP for all tumor types.ConclusionThis study confirms that EPROI locates resistant tumor hypoxic regions for radiation boost, increasing clonogenic LTCP, with potential enhanced therapeutic index in three tumor types. Preclinical absolute EPROI may provide correction for clinical hypoxia images using additional clinical physiologic MRI

Presentation_1_Absolute oxygen-guided radiation therapy improves tumor control in three preclinical tumor models.pdf

BackgroundClinical attempts to find benefit from specifically targeting and boosting resistant hypoxic tumor subvolumes have been promising but inconclusive. While a first preclinical murine tumor type showed significant improved control with hypoxic tumor boosts, a more thorough investigation of efficacy from boosting hypoxic subvolumes defined by electron paramagnetic resonance oxygen imaging (EPROI) is necessary. The present study confirms improved hypoxic tumor control results in three different tumor types using a clonogenic assay and explores potential confounding experimental conditions.Materials and methodsThree murine tumor models were used for multi-modal imaging and radiotherapy: MCa-4 mammary adenocarcinomas, SCC7 squamous cell carcinomas, and FSa fibrosarcomas. Registered T2-weighted MRI tumor boundaries, hypoxia defined by EPROI as pO2 ≤ 10 mmHg, and X-RAD 225Cx CT boost boundaries were obtained for all animals. 13 Gy boosts were directed to hypoxic or equal-integral-volume oxygenated tumor regions and monitored for regrowth. Kaplan–Meier survival analysis was used to assess local tumor control probability (LTCP). The Cox proportional hazards model was used to assess the hazard ratio of tumor progression of Hypoxic Boost vs. Oxygenated Boost for each tumor type controlling for experimental confounding variables such as EPROI radiofrequency, tumor volume, hypoxic fraction, and delay between imaging and radiation treatment.ResultsAn overall significant increase in LTCP from Hypoxia Boost vs. Oxygenated Boost treatments was observed in the full group of three tumor types (p ConclusionThis study confirms that EPROI locates resistant tumor hypoxic regions for radiation boost, increasing clonogenic LTCP, with potential enhanced therapeutic index in three tumor types. Preclinical absolute EPROI may provide correction for clinical hypoxia images using additional clinical physiologic MRI.</p