ABSTRACT
With 2176 participants recruited, D-CARE is the largest pragmatic clinical trial of dementia care strategies, to date. At four clinical trial sites (CTS), D-CARE will compare the effectiveness of three dementia care strategies over 18 months: 1) by nurse practitioners or physician assistants within a health care system, 2) by social workers or nurses at community-based service organizations (CBO), or 3) usual care. Primary outcomes include person with dementia (PWD) behavioral symptoms and caregiver strain. Other outcomes include the PWD quality of life and ability to reach personal goals, and caregiver self-efficacy, distress, and depressive symptoms. Recruitment began in June 2019 with a basic protocol in which participating providers reviewed lists generated from the electronic health records (EHR) of patients who had a diagnosis of dementia, allowing the removal of patients who should not be contacted and giving an opportunity to provide information about the family caregiver. Some practices gave "blanket” referral allowing research staff to recruit participants directly. Other practices provided direct referrals via EHR communications to the research team. Self-referrals triggered by public postings in clinics and CBOs, social media, and media coverage were also accepted if a dementia diagnosis was confirmed in the EHR. By March 16, 2020, all in-person recruitment visits were suspended due to COVID-19. In response, informed consent was switched to telephone with verbal consent as permitted by State and Institutional regulations. This symposium describes the creative approaches employed by CTS' to respond to these challenges and reach the recruitment goal in January 2022.
ABSTRACT
Background: Sarcoma pts often receive aggressive, highly immunosuppressive therapy and may be at high risk for severe COVID-19. Demographics, outcomes and risk factors for pts with sarcoma and COVID-19 are unknown. We aimed to describe the course of COVID-19 in sarcoma pts and to identify factors associated with adverse outcomes. Methods: The COVID-19 and Cancer Consortium (NCT04354701) is an international registry of pts with cancer and COVID-19. Adult pts (≥18 years old) with a diagnosis of sarcoma and laboratory confirmed SARS-CoV-2 were included from 50 participating institutions. Data including demographics, sarcoma diagnosis and treatment, and course of COVID-19 infection were analyzed. Primary outcome was the composite rate of hospitalization or death at 30 days from COVID-19 diagnosis. Secondary outcomes were 30 day all-cause mortality, rate of hospitalization, O2 need, and ICU admission. Descriptive statistics and univariate Fisher tests are reported. Results: From March 17, 2020 to February 6, 2021, N=204 pts were included. Median follow up was 42 days. Median age was 58 years (IQR 43-67). 97 (48%) were male. 30 (15%) had ECOG performance status ≥2. 104 (51%) received cancer treatment, including surgery or radiation, within 3 months of COVID-19 diagnosis. 153 (75%) had active cancer, of whom 34 (22%) had lung metastases. 100 (49%) pts met the composite primary endpoint;96 (47%) were hospitalized and 18 (9%) died within 30 days from COVID-19 diagnosis. 64 (31%) required oxygen, and 16 (8%) required ICU admission. Primary endpoint rates were similar for pts who received cytotoxic chemotherapy (38/58, 66%) or targeted therapy (16/28, 57%). Pts with higher rates of the primary endpoint included patients ≥60 years old (59% vs 40%, OR 2.04, 95% CI 1.12-3.74, p=0.016), pts with ECOG PS ≥2 vs 0-1 (90% vs 41%, OR 12.2, 95% CI 3.44-66.8, p<0.001), pts receiving any systemic therapy within 3 months of COVID-19 diagnosis (62% vs 39%, OR 2.65, 95% CI 1.43-4.97, p=0.001), and pts with lung metastases (68% vs 42%, OR 2.77, 95% CI 1.19- 6.79, p=0.013). Primary endpoint rates were similar across sarcoma subtypes (Table). Conclusions: This is the largest cohort study of pts with sarcoma and COVID-19 to date. Sarcoma pts have high rates of complications from COVID-19. Older patients, those with poor performance status, those recently receiving systemic cancer therapy, and those with lung metastases appear to have worse outcomes.