ABSTRACT
Background: Historically, less than 10% of adult patients with cancer enroll in clinical trials, however, enrollment dropped further at the onset of the COVID-19 pandemic. Barriers to trial participation during the pandemic have not been reported. As part of the TBCRC 057 survey on the impact of the pandemic on willingness to participate in breast cancer trials, we assessed reasons for reluctance to participate in trials during the pandemic. Method(s): US residents who self-reported a breast cancer diagnosis were eligible to complete the online survey 8/6/21-9/30/21. Respondents indicated whether they were current trial participants and, if not, their willingness to consider participating in a trial during the pandemic using a 5-point scale (0-not at all willing to 4-definitely willing). Respondents who were not current trial participants and who were not "definitely willing" to consider participation during the pandemic were characterized as "reluctant" and asked to select reasons for their reluctance from a checklist. Pandemic-related anxiety was assessed on an 11-point scale (0-no anxiety to 10-worst anxiety possible). Respondents indicated how the option to conduct trial activities online would affect their decision to participate in a trial (much less likely, somewhat less likely, would not affect my decision, somewhat more likely, or much more likely). In exploratory analyses, we evaluated whether pandemic-related anxiety and favorable reactions towards opportunities to conduct trial activities online were associated with reluctance to consider trial participation during the pandemic due to fear of SARS-CoV-2 exposure. Means were compared with two sample t-tests and proportions with Fisher's exact tests. Result(s): Of 385 survey respondents, 185 (48%) were characterized as reluctant to consider trial participation during the pandemic. Among these 185, median age was 55 (range 25-80), 85.7% were non-Hispanic White, 48.1% had metastatic disease and 44.2% received care at academic centers. Reasons for reluctance to consider trial participation during the pandemic cited by >=15% of the 185 reluctant respondents are shown in the Table. Respondents who selected fear of exposure to SARS-CoV-2 as a reason for their reluctance to consider participating in a trial during the pandemic had higher mean pandemic-related anxiety (7.0 vs 5.2, p< 0.001). These respondents were more likely to indicate telemedicine doctor visits (p=0.01), virtual consents (p=0.001) and online study questionnaires (p=0.001) would make them somewhat or much more likely to participate in trials than respondents who did not select fear of exposure to SARS-CoV-2 as a reason for their reluctance. Conclusion(s): Reasons for reluctance of patients with breast cancer to consider participation in clinical trials during the pandemic are multifactorial. Although concerns about safety and efficacy remain prominent, fear of exposure to SARS-CoV-2 drives unwillingness to participate in >25% of reluctant patients. Trial accrual may benefit from incorporation of electronic activities when possible.
ABSTRACT
Background: In order to maintain safety, clinical trial activities have been modified during the COVID- 19 pandemic. As part of the TBCRC 057 survey, we assessed how pandemic-related modifications to trial activities affect breast cancer patients' willingness to participate in clinical trials. Method(s): US residents with breast cancer were eligible to complete the online survey 8/6/21 - 9/30/21. Respondents rated whether each of 11 modifications to clinical trial activities would affect their decision to participate in a trial during or after the pandemic. Items evaluated modifications that involved changing the location of trial activities to closer to home, switching trial activities to telemedicine and making the trial schedule more flexible and convenient. Response options were much less likely to participate, somewhat less likely to participate, would not affect my decision whether or not to participate, somewhat more likely to participate and much more likely to participate. Current trial participants were asked to consider how modifications would affect their decision to participate in another trial. Results are reported descriptively. Result(s): Among 385 respondents, median age was 52 (range 25-85), 88.6% were non-Hispanic White, 52.5% had metastatic disease, 93% were receiving active treatment, 48.6% received care at an academic center and 9.6% were current trial participants. Changing location of trial activities was viewed favorably, with 70.2%, 64.6% and 54.1% of respondents indicating they would be much or somewhat more likely to participate if they could complete trial blood tests, x-ray tests or doctor visits closer to home, respectively. Similarly, the option to complete trial activities electronically was viewed favorably, with 59.6%, 58.6% and 60.9% of respondents indicating they would be much or somewhat more likely to participate if they could complete trial doctor visits, consent and questionnaires via telemedicine, respectively. With regard to modifications to make the trial schedule more flexible and convenient, respondent feedback was also favorable. 71.4%, 67.7% and 82.4% of respondents indicated that requiring study site visits no more than once per 3 weeks, widening windows for trial activities and offering home delivery of oral study medications, respectively, would make them much or somewhat more likely to participate. Finally, 30.4% and 51.7% indicated that the flexibility to opt-out of research-only blood tests and biopsies, respectively, would make them much or somewhat more likely to participate. Conclusion(s): Patients view modifications to trial activities implemented during the pandemic favorably. Trials should be flexible and the option to conduct study activities close to home or electronically when possible should be maintained during the pandemic and beyond.
ABSTRACT
Background: Enrollment in clinical trials has declined during the COVID-19 pandemic. Simultaneously, breast cancer patients have reported heightened anxiety. We assessed whether breast cancer patients' anxiety about the pandemic affects their willingness to participate in trials. Methods: English or Spanish- speaking US residents with breast cancer were eligible to complete the online REDCap survey 8/6/ 21 - 9/30/21. Respondents rated their anxiety about the pandemic on an 11-point scale from 0 (no anxiety) to 10 (worst anxiety possible). Anxiety scores were categorized as no/mild (0-3), moderate (4- 6) or severe (7-10). Knowledge about trials was assessed with 11 true/false items and attitudes toward trials with the Attitudes Toward Cancer Trials Scales - Cancer Treatment Subscale (ATCTS-CTS). Respondents rated their willingness to participate in a breast cancer clinical trial before and during the pandemic on 5-point scales from 0 (not at all willing) to 4 (definitely willing). Trial participants were considered “definitely willing.” Change in willingness to participate in trials during the pandemic compared to prior was defined as a binary outcome, “less willing” vs “no less willing.” Means were compared via t-test and mean difference was tested via paired t-test. Multivariable logistic regression was used to model the association of anxiety and other factors with being less willing to participate in trials during compared to prior to the pandemic. Results: Among 385 respondents, median age was 52 (range 25-85), 271 (70%) were non-Hispanic White and 202 (53%) had metastatic disease. 154 (40%) received care at academic centers and 37 (10%) were current trial participants. Most rated their anxiety as moderate (43%) or severe (38%). Mean willingness to participate in a trial was lower during compared to prior to the pandemic (2.97 vs 3.10;p < 0.0001). Fifty (13%) respondents were less willing to participate in a trial during the pandemic compared to prior. After controlling for covariates, those with severe anxiety had 5.07 times odds of being less willing to participate during the pandemic compared to prior than those with no/mild anxiety (p = 0.01). For every 1-point increase in ATCTS-CTS score (indicating better attitude toward trials) there was a 3% decrease in the odds of being less willing to participate during the pandemic (p = 0.006). For every 1-point increase in the clinical trials knowledge score (indicating more knowledge) there was a 15% decrease in the odds of being less willing to participate during the pandemic (p = 0.02). Conclusions: Pandemic-related anxiety is common in breast cancer patients and is associated with being less willing to participate in trials during the pandemic compared to prior. Education about trials, including safety modifications implemented during the pandemic, may mitigate anxiety and improve willingness to participate.
ABSTRACT
Background: Use of patient-reported outcomes (PRO) to evaluate symptoms improves clinical outcomes. Best practices for implementing PROs into routine care may vary according to clinical scenario, site-specific resources and programmatic goals. Patients with metastatic breast cancer (MBC) often experience a variety of symptoms. Methods: As a quality improvement project, we are pilot testing incorporation of a battery of PRO measures into routine care for patients with MBC at Johns Hopkins in order to gain experience that will guide future broader implementation of PROs across our program. Participants complete the PROs on paper at baseline (BL), 3, and 6 months (mo). Measures include NCCN Distress Thermometer (BL only), Patient Health Questionnaire-8 (PHQ-8), Generalized Anxiety Disorder-7 (GAD-7), PRO-CTCAE Insomnia questions and a modified version of the revised Edmonton Symptom Assessment System (rESAS) questionnaire with 3 extra symptom domains. Project team members alert clinicians by email of scores that exceed severity thresholds as follows-Distress: ≥4, PHQ-8: ≥8, GAD-7: ≥10, any item on r-ESAS: ≥4 and PROCTCAE Insomnia: Severe/very severe or quite a bit/very much. Results: From May 29, 2020 and April 5, 2021, 67 patients were approached for participation, and 40 (59.7%) completed the BL PROs. Median age was 64 (range 36-85). Most participants were White (70%), non-Hispanic (90%) and had hormone receptor-positive (93%) MBC. At BL, 22 (55%) had visceral disease and most were receiving endocrine-based regimens [21 (53%)] or chemotherapy [16 (40%)]. 27 (68%) participants had ≥1 BL alert. The most common BL alerts were for symptoms on the r-ESAS [23 participants (58%)]. The most frequent items on the r-ESAS for which participants had BL alerts were pain, tiredness, well-being, tingling/numbness and rash. Other BL alerts were: Distress [9 participants (23%)], PROCTCAE Insomnia [5 participants (13%)], PHQ-8 [4 participants (10%)] and GAD-7 [2 participants (5%)]. To date, 24 of 35 (69%) and 15 of 28 (54%) participants who have reached the 3 and 6 mo time points have completed the respective follow-up (FU) PROs. Most common FU alerts to date are on the r-ESAS [3 mo: 14 participants (58%), 6 mo: 9 participants (60%)]. The project team has successfully notified providers of all alerts to date. Clinical actions (phone calls, provider visits and/or referrals) have been taken within 30 days of notification for > 75% of alerts. Conclusions: Implementation of a PRO battery for patients receiving routine care for MBC led to detection of a range of symptoms, the majority of which were clinically actionable. Restrictions on in-person interactions during the COVID-19 pandemic may have contributed to low rates of PRO completion in this pilot project. Prior to broader implementation, we will consider strategies such as an electronic platform and a shorter battery to enhance patient engagement.
ABSTRACT
Background: Children and young adults were initially reported as largely spared from severe complications of SARS-CoV-2 infection, but the impact to this population has been significant. Methods: This observational retrospective cohort study includes 420 symptomatic children and young adults with lab confirmed SARS-CoV-2 infection treated between March 15 and June 16, 2020 at Children's National Hospital in Washington DC. We identified and compared cohorts of non-hospitalized (N=324) and hospitalized (N=96) patients, including non-critically ill (N=64) and critically ill hospitalized (N=32) patients. Clinical and demographic data were extracted from medical records Results: Of 420 SARS-CoV-2-infected symptomatic patients, 23% required hospitalization, of which 67% were non-critically ill and 33% were critically ill. All age groups were represented in the symptomatic cohort, with a median age of 8.6 years. Patients > 15 years of age represented 44% of critical care admissions. Males and females were equally represented in all cohorts. Underlying medical conditions were present in 36%, but more common in hospitalized (59 %) and critically ill (66 %) patients. The most frequent underlying diagnosis overall was asthma (16 %), but also included neurologic (6 %), diabetes (3 %), obesity (3 %), cardiac (3 %), hematologic (3 %) and oncologic (1 %) conditions. The majority (66 %) of SARSCoV- 2 infected patients presented with respiratory symptoms with or without fever. Other symptoms were also present, including diarrhea/vomiting (21 %), myalgia (11 %), chest pain (8 %) and loss of sense of smell or taste (7%). Hospitalized patients required varying levels of respiratory support, including mechanical ventilation, BiPAP, RAM cannula and HFNC. Additional presentations included diabetic hyperglycemia, sickle cell vaso-occlusive crisis, vascular complications, and multisystem inflammation. Treatment included remdesivir, convalescent plasma, tocilizumab and other therapies. Conclusion: Although children/young adults have been less affected than elderly adults, the impact of SARS-CoV2 on this population has been significant in Washington DC and informs other regions anticipating their surge.
ABSTRACT
Background: Background: Multi-system Inflammatory Syndrome of Children (MIS-C) has recently emerged internationally as a serious inflammatory complication of SARS-CoV-2 infection with significant morbidity for the pediatric population. Methods: This observational retrospective cohort study includes 33 children meeting CDC criteria for MIS-C treated between March 15 and June 17, 2020 at Children's National Hospital in Washington DC. Clinical and demographic data were extracted from medical records and are summarized. Results: Of 33 hospitalized MIS-C patients, 42% were critically ill, and 58% were non-critically ill. The median age was 8.9 years (0.7-18.7 years). More males (58 %) than females (43 %) were represented in the MIS-C cohort. The majority (75%) of children had no underlying medical condition. Criteria for incomplete or complete Kawasaki Disease (KD) were present in 39% of patients, while an additional 9% had some features of KD. However the remaining 52% of MIS-C patients presented with other sub-phenotypes including prominent severe abdominal pain and/or nonspecific multiorgan dysfunction. 30% presented with shock requiring volume and/or inotropic support. SARS-CoV-2 antibodies were present in 61% of patients. Virus was detectable by PCR in 36% of patients. At the time of initial evaluation, 39% (13/33) of children had identified cardiac abnormalities including myocardial dysfunction (5/33;15%), coronary ectasia (4/33;12%), coronary aneurysm (3/33;9%), or pericardial effusion 5/33;15%) either alone or in combination. Cytokine profiling identified elevation of several cytokines in this cohort, including IL-6. Treatment has included intravenous immunoglobulin, aspirin, anakinra and other immunomodulatory therapies, with overall rapid response to therapy. No deaths have occurred. Conclusion: The emergence of MIS-C late in the surge of SARS-CoV-2 circulation in the Washington DC metropolitan region has added to the already significant burden of hospitalized and critically ill children in our region. A significant percentage of these children present with cardiac dysfunction and abnormalities, whether or not with KD features at presentation. Detailed characterization of immune responses and long term outcome of these patients is a priority.