JCO oncology practice最新文献

Purpose: Over the course of the COVID-19 pandemic, the Food and Drug Administration allowed cancer clinical trials to make modifications. As policymakers consider sustaining these modifications, understanding patient perspectives on impact is critical.

Methods: This cross-sectional study used survey data collected between August 2021 and September 2021 by the Translational Breast Cancer Research Consortium and December 2022 by Patient Advocate Foundation among female breast cancer survivors. Respondents reported how changes to location, telemedicine, convenience, and opting out of certain procedures would affect their willingness to participate in a trial. Respondents' county-level vulnerability was determined using five-digit Federal Information Processing Standard codes to link to the Social Vulnerability Index (SVI) overall theme (range, 0-1). According to the SVI, the most vulnerable counties are those in the upper 10% of the overall theme. Model-estimated odds ratios (ORs) and 95% CIs were estimated using multinomial logistic regression models to explore the association between county-level social vulnerability and willingness to participate.

Results: Overall, 573 women were included, 12% lived in the most vulnerable counties, and 18% had previous trial participation. Over half (53%) reported that they would be very willing to participate in a trial that offered medication delivery to the home. When compared with all other counties, respondents in most vulnerable counties did not have increased willingness to participate in a trial using telemedicine (OR, 0.21 [95% CI, 0.07 to 0.63]). Results were similar for all other trial modifications, though not statistically significant.

Conclusion: Our sample of breast cancer survivors viewed trial modifications favorably. However, respondents in the most vulnerable counties were less likely to be influenced by these modifications. Research is needed to understand if additional modifications would influence participation of this vulnerable population.

Purpose: Minority representation in cancer-related clinical trials (CCTs) is often inadequate. This poses a threat to the generalizability of studies and risks promoting health inequities. This scoping review set out to examine strategies to promote minority participation in CCTs and across the entire continuity of cancer-related care.

Methods: We reviewed articles in the following databases: EMBASE, Scopus, and PubMed. For inclusion, studies were required to focus, to a significant extent, on interventions to increase minority enrollment/retention. They were also required to objectively report the strength of these interventions, and either compare them with a control, or with a different intervention attempted.

Results: After initially identifying 817 articles, we reviewed 337 articles in their entirety, and found 37 that satisfied our full list of inclusion and exclusion criteria. Five general categories of interventions emerged in these studies. These included educational interventions (n = 17), patient navigation (n = 12), community engagement (n = 8), autonomous recruitment strategies (n = 4), and financial assistance/incentives (n = 4). We then examined rates of statistical significance (for studies that assessed this). Seven of 10 articles that used education intervention strategies and assessed statistical significance demonstrated improvement in at least one variable. For patient navigation, 5/5 showed significance. For community engagement, 1/1 found a significant difference. For studies using an autonomous recruitment strategy, 2/2 showed an improvement. Finally, for financial assistance/incentives, 1/3 found a significant improvement in minority enrollment.

Conclusion: Our study highlights the critical role of tailored educational interventions and patient navigation in increasing minority participation in cancer-related clinical trials. However, all five categories of interventions showed promise. More research is needed, particularly in assessing the efficacy of multipronged approaches, to ensure adequate minority participation in CCTs.

Purpose: The Anal Cancer/High-grade squamous intraepithelial lesions Outcomes Research (ANCHOR) trial demonstrated that treating precancerous anal HSIL reduces the incidence of anal cancer by 57% in people with HIV. It remains unclear how HSIL treatment or monitoring without treatment affects patient-reported health-related quality of life (HRQoL). We evaluated differences in HRQoL for individuals who were randomly assigned to active monitoring (AM) or treatment for anal HSIL.

Methods: Using an index designed and validated for use in ANCHOR, HRQoL was assessed before random assignment (T1), 2-7 days (+3 days) after random assignment/treatment (T2), and 28 days (±7 days) after random assignment/treatment (T3).

Results: ANCHOR participants living with HIV (N = 124; mean [standard deviation, SD] age, 52.6 years [10.3]; n = 101 [81.5%] men; n = 65 [52.4%] White; n = 95 [76.6%] non-Hispanic; treatment n = 70 [56.4%]; and AM n = 54 [43.6%]) were included. Treatment arm participants had significant mean worsening from T1-T2 in physical symptoms (mean [SD] difference, 0.31 [0.51]; P = .0001) and impact on psychological functioning (mean [SD] difference, 0.25 [0.64]; P = .022) that significantly improved to T1 levels from T2-T3 (ie, mean [SD] difference, -0.25 [0.52]; P = .003; and mean [SD] difference, -0.07 [0.23]; P = .039, respectively). AM arm participants experienced significant mean improvement in impact on psychological functioning from T1-T3 (mean [SD], difference, -0.20 [0.50]; P = .017). After adjusting for T1, treatment arm participants had a larger mean improvement than AM arm participants in physical symptoms from T2-T3 (mean [SD] difference, -0.25 [0.52]; P = .024); no between-arm differences were observed for impact on physical or psychological functioning.

Conclusion: Treatment arm participants experienced significant worsening in physical symptoms and impact on psychological functioning from T1-T2 but returned to prerandomization levels by T3, indicating that any immediate anal HSIL treatment-related impacts to HRQoL are temporary. Further research is needed to determine long-term impacts of anal HSIL treatment on HRQoL.