RECRUITMENT AND RETENTION OF PATIENT-PARTNER DYADS FROM A CANCER REGISTRY FOR AN E-HEALTH INTERVENTION DELIVERED IN A RANDOMIZED CONTROLLED TRIAL

Healthcare Delivery Randomized clinical trials (RCT) that test the effects of dyadic interventions often face challenges in recruitment and retention. Because most cancer-focused RCTs recruit convenience samples from local cancer centers and hospitals, little is known about recruitment and retention using a population-based cancer cohort. This study describes the recruitment and retention of patient-partner dyads using a cancer registry to obtain participants for an RCT testing the efficacy of a dyadic, tailored eHealth intervention to improve quality of life in patients with prostate cancer and their partners. This study was a two-arm, parallel groups RCT. Men who recently completed treatment for localize prostate cancer were recruited from the North Carolina Central Cancer Registry Rapid Case Ascertainment (NCCCR RCA) from April 2018 to February 2021. Notably, recruitment coincided with the COVID-19 pandemic. After receiving a list of patients from the NCCCR RCA, we mailed patients' physicians an introductory letter that included the ability to opt out if they preferred that their patient(s) not participate. Next, introductory letters were mailed to patients, who were further screened for eligibility, invited to participate, and asked for permission to contact their partner. Using the same procedure, we obtained informed consent from the partners for their study participation. After baseline assessments, patient-partner dyads were randomly assigned to the intervention or control group. Dyads completed follow-up surveys 4-, 8-, and 12-month post-baseline. Data for this report were extracted from the research administrative log and analyzed using descriptive analyses. See the Consort Diagram (Fig.i) for participant flow through the study. Of 3,078 patients referred from RCA, 2,899 were contacted for screening;2,195 partners were approached after obtaining patients' permission;280 patient-partner dyads completed baseline assessments and were randomized (enrollment rate: 12.76%;95% CI (11.39%, 14.22%);and 221 dyads completed the 12-month follow-up (retention rate: 78.93%;95% CI (73.68%, 83.56%). Referral and recruitment were significantly affected by the pandemic. Conclusions: Despite the negative impacts of the COVID-19 pandemic, we used the NCCCR RCA to achieve a recruitment rate for patient-partner dyads that was equivalent to other epidemiologic cohort studies. Our retention rate was higher than the retention rates in most dyadic intervention studies (69%). A well-functioning research team and specific strategies (e.g. eHealth intervention, Internet phone, online surveys) facilitated recruitment and retention in this population-based, dyadic study with cancer patients and their partners.

Changes Over Time in COVID-19 Severity and Mortality in Patients Undergoing Cancer Treatment in the United States: Initial Report From the ASCO Registry.

PURPOSE: People with cancer are at increased risk for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. ASCO's COVID-19 registry promotes systematic data collection across US oncology practices. METHODS: Participating practices enter data on patients with SARS-CoV-2 infection in cancer treatment. In this analysis, we focus on all patients with hematologic or regional or metastatic solid tumor malignancies. Primary outcomes are 30- and 90-day mortality rates and change over time. RESULTS: Thirty-eight practices provided data for 453 patients from April to October 2020. Sixty-two percent had regional or metastatic solid tumors. Median age was 64 years. Forty-three percent were current or previous cigarette users. Patients with B-cell malignancies age 61-70 years had twice mortality risk (hazard ratio = 2.1 [95% CI, 1.3 to 3.3]) and those age > 70 years had 4.5 times mortality risk (95% CI, 1.8 to 11.1) compared with patients age ≤ 60 years. Association between survival and age was not significant in patients with metastatic solid tumors (P = .12). Tobacco users had 30-day mortality estimate of 21% compared with 11% for never users (log-rank P = .005). Patients diagnosed with SARS-CoV-2 before June 2020 had 30-day mortality rate of 20% (95% CI, 14% to 25%) compared with 13% (8% to 18%) for those diagnosed in or after June 2020 (P = .08). The 90-day mortality rate for pre-June patients was 28% (21% to 34%) compared with 21% (13% to 28%; P = .20). CONCLUSION: Older patients with B-cell malignancies were at increased risk for death (unlike older patients with metastatic solid tumors), as were all patients with cancer who smoke tobacco. Diagnosis of SARS-CoV-2 later in 2020 was associated with more favorable 30- and 90-day mortality, likely related to more asymptomatic cases and improved clinical management.

Association of Cancer Screening Deficit in the United States With the COVID-19 Pandemic.

Importance: The COVID-19 pandemic led to sharp declines in cancer screening. However, the total deficit in screening in the US associated with the pandemic and the differential impact on individuals in different geographic regions and by socioeconomic status (SES) index have yet to be fully characterized. Objectives: To quantify the screening rates for breast, colorectal, and prostate cancers associated with the COVID-19 pandemic in different geographic regions and for individuals in different SES index quartiles and estimate the overall cancer screening deficit in 2020 across the US population. Design, Setting, and Participants: This retrospective cohort study uses the HealthCore Integrated Research Database, which comprises single-payer administrative claims data and enrollment information covering approximately 60 million people in Medicare Advantage and commercial health plans from across geographically diverse regions of the US. Participants were individuals in the database in January through July of 2018, 2019, and 2020 without diagnosis of the cancer of interest prior to the analytic index month. Exposures: Analytic index month and year. Main Outcomes and Measures: Receipt of breast, colorectal, or prostate cancer screening. Results: Screening for all 3 cancers declined sharply in March through May of 2020 compared with 2019, with the sharpest decline in April (breast, -90.8%; colorectal, -79.3%; prostate, -63.4%) and near complete recovery of monthly screening rates by July for breast and prostate cancers. The absolute deficit across the US population in screening associated with the COVID-19 pandemic was estimated to be 3.9 million (breast), 3.8 million (colorectal), and 1.6 million (prostate). Geographic differences were observed: the Northeast experienced the sharpest declines in screening, while the West had a slower recovery compared with the Midwest and South. For example, percentage change in breast cancer screening rate (2020 vs 2019) for the month of April ranged from -87.3% (95% CI, -87.9% to -86.7%) in the West to -94.5% (95% CI, -94.9% to -94.1%) in the Northeast (decline). For the month of July, it ranged from -0.3% (95% CI, -2.1% to 1.5%) in the Midwest to -10.6% (-12.6% to -8.4%) in the West (recovery). By SES, the largest screening decline was observed in individuals in the highest SES index quartile, leading to a narrowing in the disparity in cancer screening by SES in 2020. For example, prostate cancer screening rates per 100 000 enrollees for individuals in the lowest and highest SES index quartiles, respectively, were 3525 (95% CI, 3444 to 3607) and 4329 (95% CI, 4271 to 4386) in April 2019 compared with 1535 (95% CI, 1480 to 1589) and 1338 (95% CI, 1306 to 1370) in April 2020. Multivariable analysis showed that telehealth use was associated with higher cancer screening. Conclusions and Relevance: Public health efforts are needed to address the large cancer screening deficit associated with the COVID-19 pandemic, including increased use of screening modalities that do not require a procedure.

Prostate Cancer Radiation Therapy Recommendations in Response to COVID-19.

PURPOSE: During a global pandemic, the benefit of routine visits and treatment of patients with cancer must be weighed against the risks to patients, staff, and society. Prostate cancer is one of the most common cancers radiation oncology departments treat, and efficient resource utilization is essential in the setting of a pandemic. Herein, we aim to establish recommendations and a framework by which to evaluate prostate radiation therapy management decisions. METHODS AND MATERIALS: Radiation oncologists from the United States and the United Kingdom rapidly conducted a systematic review and agreed upon recommendations to safely manage patients with prostate cancer during the COVID-19 pandemic. A RADS framework was created: remote visits, and avoidance, deferment, and shortening of radiation therapy was applied to determine appropriate approaches. RESULTS: Recommendations were provided by the National Comprehensive Cancer Network risk group regarding clinical node-positive, postprostatectomy, oligometastatic, and low-volume M1 disease. Across all prostate cancer stages, telemedicine consultations and return visits were recommended when resources/staff available. Delays in consultations and return visits of between 1 and 6 months were deemed safe based on stage of disease. Treatment can be avoided or delayed until safe for very low, low, and favorable intermediate-risk disease. Unfavorable intermediate-risk, high-risk, clinical node-positive, recurrence postsurgery, oligometastatic, and low-volume M1 disease can receive neoadjuvant hormone therapy for 4 to 6 months as necessary. Ultrahypofractionation is preferred for localized, oligometastatic, and low-volume M1, and moderate hypofractionation is preferred for postprostatectomy and clinical node positive disease. Salvage is preferred to adjuvant radiation. CONCLUSIONS: Resources can be reduced for all identified stages of prostate cancer. The RADS (remote visits, and avoidance, deferment, and shortening of radiation therapy) framework can be applied to other disease sites to help with decision making in a global pandemic.

Prostate Cancer Radiation Therapy Recommendations in Response to COVID-19.

PURPOSE: During a global pandemic, the benefit of routine visits and treatment of patients with cancer must be weighed against the risks to patients, staff, and society. Prostate cancer is one of the most common cancers radiation oncology departments treat, and efficient resource utilization is essential in the setting of a pandemic. Herein, we aim to establish recommendations and a framework by which to evaluate prostate radiation therapy management decisions. METHODS AND MATERIALS: Radiation oncologists from the United States and the United Kingdom rapidly conducted a systematic review and agreed upon recommendations to safely manage patients with prostate cancer during the COVID-19 pandemic. A RADS framework was created: remote visits, and avoidance, deferment, and shortening of radiation therapy was applied to determine appropriate approaches. RESULTS: Recommendations were provided by the National Comprehensive Cancer Network risk group regarding clinical node-positive, postprostatectomy, oligometastatic, and low-volume M1 disease. Across all prostate cancer stages, telemedicine consultations and return visits were recommended when resources/staff available. Delays in consultations and return visits of between 1 and 6 months were deemed safe based on stage of disease. Treatment can be avoided or delayed until safe for very low, low, and favorable intermediate-risk disease. Unfavorable intermediate-risk, high-risk, clinical node-positive, recurrence postsurgery, oligometastatic, and low-volume M1 disease can receive neoadjuvant hormone therapy for 4 to 6 months as necessary. Ultrahypofractionation is preferred for localized, oligometastatic, and low-volume M1, and moderate hypofractionation is preferred for postprostatectomy and clinical node positive disease. Salvage is preferred to adjuvant radiation. CONCLUSIONS: Resources can be reduced for all identified stages of prostate cancer. The RADS (remote visits, and avoidance, deferment, and shortening of radiation therapy) framework can be applied to other disease sites to help with decision making in a global pandemic.