Impact of the COVID-19 Pandemic on Oncology Clinical Research in Latin America (LACOG 0420).

PURPOSE: COVID-19 has affected cancer care worldwide. Clinical trials are an important alternative for the treatment of oncologic patients, especially in Latin America, where trials can be the only opportunity for some of them to access novel and, sometimes, standard treatments. METHODS: This was a cross-sectional study, in which a 22-question survey regarding the impact of the COVID-19 pandemic on oncology clinical trials was sent to 350 representatives of research programs in selected Latin American institutions, members of the Latin American Cooperative Oncology Group. RESULTS: There were 90 research centers participating in the survey, with 70 of them from Brazil. The majority were partly private or fully private (n = 77; 85.6%) and had confirmed COVID-19 cases at the institution (n = 57; 63.3%). Accruals were suspended at least for some studies in 80% (n = 72) of the responses, mostly because of sponsors' decision. Clinical trials' routine was affected by medical visits cancelation, reduction of patients' attendance, reduction of other specialties' availability, and/or alterations on follow-up processes. Formal COVID-19 mitigation policies were adopted in 96.7% of the centers, including remote monitoring and remote site initiation visits, telemedicine visits, reduction of research team workdays or home office, special consent procedures, shipment of oral drugs directly to patients' home, and increase in outpatient diagnostic studies. Importantly, some of these changes were suggested to be part of future oncology clinical trials' routine, particularly the ones regarding remote methods, such as telemedicine. CONCLUSION: To our knowledge, this was the first survey to evaluate the impact of COVID-19 on Latin American oncology clinical trials. The results are consistent with surveys from other world regions. These findings may endorse improvements in clinical trials' processes and management in the postpandemic period.

Pacific island 'Awa (Kava) extracts, but not isolated kavalactones, promote proinflammatory responses in model mast cells.

Kava ('Awa) is a traditional water-based beverage in Pacific island communities, prepared from the ground root and stems of Piper methysticum. Kava use is associated with an ichthyotic dermatitis and delayed type hypersensitivity reactions. In the current study we collated preparative methodologies from cultural practitioners and recreational kava users in various Pacific communities. We standardized culturally informed aqueous extraction methods and prepared extracts that were subjected to basic physicochemical analysis. Mast cells exposed to these extracts displayed robust intracellular free calcium responses, and concomitant release of proinflammatory mediators. In contrast, mast cells were refractory to single or combinatorial stimulation with kavalactones, including methysticin, dihydromethysticin and kavain. Moreover, we reproduced a traditional modification of the kava preparation methodology, pre-mixing with the mucilage of Hibiscus tiliaceus, and observed its potentiating effect on the activity of aqueous extracts in mast cells. Taken together, these data indicate that water extractable active ingredients may play a role in the physiological and pathophysiological effects of kava, and suggests that mast cell activation may be a mechanistic component of kava-related skin inflammations.

A family and community focused lifestyle program prevents weight regain in Pacific Islanders: a pilot randomized controlled trial.

Preventing weight regain after the loss of excess weight is challenging for people, especially for ethnic minorities in the United States. A 6-month weight loss maintenance intervention designed for Pacific Islanders, called the PILI Lifestyle Program (PLP), was compared with a 6-month standard behavioral weight loss maintenance program (SBP) in a pilot randomized controlled trial using a community-based participatory research approach. Adult Pacific Islanders (N = 144) were randomly assigned to either PLP (n = 72) or SBP (n = 72) after completing a 3-month weight loss program. Successful weight maintenance was defined as participants' postintervention weight change remaining ≤ 3% of their preintervention mean weight. Both PLP and SBP participants achieved significant weight loss maintenance (p ≤ .05). Among participants who completed at least half of the prescribed sessions, PLP participants were 5.1-fold (95% confidence interval = 1.06, 24; p = .02) more likely to have maintained their initial weight loss than SBP participants. The pilot PLP shows promise as a lifestyle intervention to address the obesity disparities of Pacific Islanders and thus warrants further investigation.

Translating diabetes prevention into native Hawaiian and Pacific Islander communities: the PILI 'Ohana Pilot project.

BACKGROUND: Native Hawaiians (NH) and Other Pacific Islanders (OPI) bear an excess burden of diabetes health disparities. Translation of empirically tested interventions such as the Diabetes Prevention Program Lifestyle Intervention (DPP-LI) offers the potential for reversing these trends. Yet, little is known about how best to translate efficacious interventions into public health practice, particularly among racial/ethnic minority populations. Community-based participatory research (CBPR) is an approach that engages the community in the research process and has recently been proposed as a means to improve the translation of research into community practice. OBJECTIVES: To address diabetes health disparities in NHOPIs, CBPR approaches were used to: (1) culturally adapt the DPP-LI for NHOPI communities; and (2) implement and examine the effectiveness of the culturally-adapted program to promote weight loss in 5 NHOPI communities. METHODS: Informant interviews (n=15) and focus groups (n=15, with 112 NHOPI participants) were completed to inform the cultural adaptation of the DPP-LI program. A team of 5 community investigators and 1 academic research team collaboratively developed and implemented the 12-week pilot study to assess the effectiveness of the culturally adapted program. RESULTS: A total of 127 NHOPIs participated in focus groups and informant interviews that resulted in the creation of a significantly modified version of the DPP-LI, entitled the PILI 'Ohana Lifestyle Intervention (POLI). In the pilot study, 239 NHOPIs were enrolled and after 12 weeks (post-program), mean weight loss was -1.5 kg (95%CI -2.0, -1.0) with 26% of participants losing > or = 3% of their baseline weight. Mean weight loss among participants who completed all 8 lessons at 12 weeks was significantly higher (-1.8 kg, 95%CI -2.3, -1.3) than participants who completed less than 8 lessons (-0.70 kg, 95%CI -1.1, -0.29). CONCLUSION: A fully engaged CBPR approach was successful in translating an evidence based diabetes prevention program into a culturally relevant intervention for NHOPI communities. This pilot study demonstrates that weight loss in high risk minority populations can be achieved over a short period of time using CBPR approaches.