Cristiane Decat Bergerot | City of Hope (original) (raw)

Papers by Cristiane Decat Bergerot

Europe PMC (PubMed Central), 2017

Journal of Clinical Oncology, Jun 1, 2023

Cancer Research, Jun 15, 2022

Background: In a previous randomized phase I trial, addition of CBM-588 to the nivolumab/ipilimum... more Background: In a previous randomized phase I trial, addition of CBM-588 to the nivolumab/ipilimumab (N/I) regimen showed improved objective response rate, clinical benefit rate, and progression free survival compared to N/I alone in patients (pts) with metastatic renal cell carcinoma (mRCC; Meza et al., ASCO 2021). Furthermore, genomic alterations such as PBRM1 have been associated with clinical benefit to anti-PD-1 monotherapy in patients with mRCC (Miao et al., Science 2018). The primary aim of this study was to investigate tumor genomic characteristics according to treatment arms. Methods: We retrospectively identified pts with mRCC who received N/I alone or with CBM-588 supplementation along with whole exome and transcriptome sequencing (Ashion Analytics). Responses were measured according to RECIST v1.1. A two-tailed Fischer’s exact test was performed to compare genomic characteristics across arms. Results: In this study, 29 mRCC pts were randomized to receive N/I +/- CBM-588 and 21 (72%) pts (71% in N/I with CBM-588 arm and 29% N/I arm) had available genomic data. Within this cohort, the median age was 66.8 (range 46-90) and 71% of pts were male. Eleven (52.4%) pts had clear-cell histology and 10 (47.6%) pts had sarcomatoid features; 15 pts received N/I with CBM-588 and 6 pts received N/I alone. The most commonly mutated genes in the overall cohort were VHL (61.9%), PBRM1 (42.9%), and SETD2 (33.3%). Alterations in VHL, PBRM1, and SETD2 were seen in 66.7% vs. 73.3% (p=0.115), 50.0% vs. 40.0% (p=0.523) and 33.3% vs. 33.3% (p=0.686), in N/I vs. N/I with CBM-588 arm, respectively. Conclusions: There was no significant difference observed in clinically relevant genomic features across study arms. The clinical benefit from CBM-588 appears to be independent of tumor genomic characteristics. More extensive investigations are needed to characterize the determinants of benefit from CBM-588 supplementation. Citation Format: Daniela V. Castro, Nazli Dizman, Zeynep B. Zengin, Jasnoor Malhotra, Luis A. Meza, Ramya Muddasani, Ameish Govindarajan, Neal S. Chawla, Alex Chehrazi-Raffle, JoAnn Hsu, Paulo G. Bergerot, Cristiane D. Bergerot, Tanya B. Dorff, Yung Lyou, Sumanta K. Pal. Genomic characteristics of nivolumab/ipilimumab with or without CBM-588 supplementation in patients with metastatic renal cell carcinoma [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2022; 2022 Apr 8-13. Philadelphia (PA): AACR; Cancer Res 2022;82(12_Suppl):Abstract nr 6293.

Journal of Clinical Oncology, Feb 20, 2022

324 Background: mRCC is associated with high rates of distress, high levels of symptom burden, an... more 324 Background: mRCC is associated with high rates of distress, high levels of symptom burden, and broad impairments in quality of life. In the setting of localized breast cancer, a smartphone application directed at enhancing mindfulness has been developed from a Mindfulness-Based Cancer Recovery program demonstrated to mitigate these factors (Utkarsh et al. Digital Health 2021); we sought to determine if the benefit of a similar application could be translated to patients with mRCC. Methods: Patients were recruited across two sites in the US and Brazil, and were eligible for the study if they had been diagnosed with mRCC, were receiving immunotherapy, reported clinically-relevant anxiety, had a smart phone with internet access, were currently not engaging in meditation, and had not participated in a mindfulness program in the past 5 years. Patients were asked to participate in mindfulness app-based activities for 20-30 minutes each day guided by the Mindfulness-Based Cancer Survivorship Journey program within AM Mindfulness smartphone app (AmDTx™), for a minimum of 4 days per week, over a period of 4 weeks. The application leads the patient through exercises in guided meditation and suggestions for cancer/cancer symptom coping. Patients were assessed at baseline and 2-weeks after using the 4-week smartphone-app based intervention using the Fear of Cancer Recurrence-7 and Functional Assessment of Chronic Illness Therapy-General scales. Reported data is evaluated using paired t-tests with a p-value of < 0.05 considered significant. Results: A total of 23 patients have been recruited to date. Median age was 59 years old; most were male (52%), white/Caucasian (52%), married (69%) and college educated (82%), and primarily receiving treatment with nivolumab (34%) or nivolumab/ipilimumab (30%). The majority of patients (78%) expressed satisfaction and engaged with the intervention; however, a minority (13%) noted that the intervention reminded them of their cancer diagnosis, which was seen as a negative aspect. Preliminary analyses of data after two weeks of the intervention have demonstrated a statistically significant decreases in fear of cancer progression (mean differences: baseline = 22; week 2 = 18, p = 0.012) and increases in quality of life (mean differences: baseline = 77; week 2 = 85, p = 0.001) over time. Physical and emotional well-being also showed significant improvement over time. Complete data with 12 weeks of follow-up will be presented at the meeting. Conclusions: This is the first study to implement an evidence-based, smartphone-accessible psychosocial support tool among mRCC patients. After only two weeks, we noted significant improvements in the fear of cancer progression and quality of life. This preliminary data suggests that this type of low-cost, mobile-app based intervention was acceptable to patients and may be effective at addressing psychosocial distress

Journal of Clinical Oncology, Feb 20, 2021

75 Background: Exposure to bright white light (BWL) has been shown to improve outcomes including ... more 75 Background: Exposure to bright white light (BWL) has been shown to improve outcomes including fatigue, depression, and sleep disturbances among the general older population but the benefit has not been demonstrated as yet in prostate cancer. Older men with prostate cancer on androgen deprivation therapy (ADT) are at risk for obese frailty (components: fatigue, weakness, poor mood, slowness and obesity). In this pilot study, we aimed to determine if BWL, compared to dim white wight (DWL), reduces obese frailty in older prostate cancer patients starting anti-androgens. Methods: Men age ≥ 65 with prostate cancer initiating ADT were randomly assigned to either the BWL (exposure to full spectrum light, 500-1500 lux) or DWL cohort (exposure to low dose white light (&lt;50 lux)) and were blinded to assignment. Men received daily 30-minute morning light session from special glasses (Luminette) for 3 months. Participants were assessed at the beginning of treatment and 3 months later with the Short Physical Performance Battery (SPPB) - including timed 4m walk, tandem balance, and timed chair stands (range: 0 to 12) - energy levels (self-reported 5-point Likert scale), waist circumference (measured via tape (mm)), and muscle strength (handgrip: assessed via dynamometer (kg)). Pre-post outcomes (means differences) were evaluated using paired t-tests with a p-value of 0.05 considered significant. Results: 18 patients (9 per cohort) were recruited. Patients in the BWL arm showed a statistically significant improvement in muscle strength (BWL p=0.012 versus in DWL p=0.22). Compared with DWL, BWL arm showed no decline in energy levels, (BWL p=0.28 vs. DWL p=0.035) nor gain in waist circumference (BWL p=0.51, DWL p=0.046). There were no statistically significant differences in either arm on the SPPB (BWL p=0.44, and in DWL p=0.09). Conclusions: BWL may offset negative effects of ADT for older men with prostate cancer, through improved muscle strength, maintained energy levels, and no waist circumference gain. While a small pilot study, the intervention warrants further research in a larger sample.

Journal of Clinical Oncology, Feb 20, 2022

336 Background: SBRT in indicated for the management of locally recurrent and oligometastatic mRC... more 336 Background: SBRT in indicated for the management of locally recurrent and oligometastatic mRCC as per National Comprehensive Cancer Network guidelines. Our study evaluates both the efficacy of radiotherapy (RT) in prolonging systemic treatment along with RT toxicity in the oligoprogressive RCC setting. Methods: A single institution retrospective data collection was performed in which we identified mRCC patients who experienced oligoprogression (defined as <1 sites of progressive disease) while on an FDA approved systemic therapy and were concurrently treated with SBRT, while remaining on the same therapy. Clinicopathologic characteristics and SBRT-related data along with duration of systemic therapy (DOT) were collected. DOT was then quantified into two categories which included the duration of systemic therapy prior to oligoprogression (DOT[P]) and duration of systemic therapy after completion of SBRT (DOT[S]). The ratio of DOT[S]/DOT[P] was calculated to determine the impact of SBRT on systemic treatment prolongation. Results: 23 patients diagnosed with mRCC meeting criteria were identified, 91% (n = 21) with clear cell histology and 9% (n = 2) with papillary histology. At the time of oligoprogression, 15 patients (65%) were on immunotherapy, 7 patients (30%) were on targeted therapy, and 1 patient (5%) was on combination therapy. We noted the preponderance of patients were on a first-line therapy at the time of oligoprogression (n = 10, 43%). A median of 2 (range, 1-3) lesions were treated per patient, with lung being the most frequent site (n = 14, 40%). The median total dose of SBRT was 30 Gy (range, 27-50 Gy) with a median dose per fraction of 6 Gy (range, 3-12 Gy). SBRT related toxicities, all of which were grade <2, were noted in 5 patients (22%), of which fatigue was the most frequent side effect (n = 3, 13%). Median DOT[S] was 13.4 months (range, 0.5-37.7 months) and the median DOT[P] was 12.8 months (range, 0.4-46.3 months). Results demonstrated a median DOT[S]/DOT[P] ratio to be 1.3 (range, 0.01-25.8). Conclusions: Based on our data, we discovered the addition of SBRT to systemic therapy during oligoprogression is not only well-tolerated, but that this treatment had clinical benefit in prolonging time on systemic therapy for patients with mRCC. The utilization of SBRT may prolong lines of therapy, thereby decreasing additional toxicities associated with exposure to new regimens.

Journal of Clinical Oncology, Oct 1, 2021

313 Background: Treatment decisions for patients with cancer have changed during the COVID-19 pan... more 313 Background: Treatment decisions for patients with cancer have changed during the COVID-19 pandemic due to the increased risk of infection among this population. In recognition of the impact of COVID-19 in Brazil, this study sought to explore the potential consequences of this disruption to oncology care by comparing the prevalence and place of death one year prior to the pandemic (January 2019 to February 2020) and during the pandemic (March 2020 to March 2021). Methods: Consecutive patients with cancer receiving treatment at a single institution located in the capital of Brazil were included in this analysis. Patients’ characteristics were collected via chart review: age, sex, histology, COVID-19, hospital admission and place of death. Chi-square analysis was used to determine differences among this sample of patients (pre-COVID-19 and during COVID-19). Results: We reviewed data from 3,833 patients (53% of patients during the pandemic). Patients’ characteristics were well balanced between both groups of patients. The proportion of patients with breast and prostate cancers increased (P < 0.01). Rates of hospital admission were similar between both timepoint, with reasons for hospital admission also similar: surgery (22% vs 19%, respectively) and pulmonary dysfunction (14% vs 19%, respectively); 9% were diagnosed with COVID-19 during the pandemic. Similarly, no differences were found among rates of deaths between samples (7%); 42% of patients pre-COVID were receiving supportive care, while 40% were during pandemic. The proportion of patients dying at home was the same among both groups (12%). A slight increase was observed for those dying in the ICU (45% vs 46%, respectively) or hospital (35% vs 36%, respectively). Pre-COVID-19, no patient has died in the emergency room, and during pandemic, 3% has died). Conclusions: A similar proportion of hospital admission and place of death were found between patients prior and during the COVID-19 pandemic. Most patients died in institutional settings. Future studies are needed to better understand patient’s wishes and preferences and to develop strategies to improve communication surrounding death and dying.

Journal of Clinical Oncology, Jun 1, 2023

Journal of Clinical Oncology, Feb 20, 2023

614 Background: Racial minorities experience intersecting forms of marginalization and suffer sig... more 614 Background: Racial minorities experience intersecting forms of marginalization and suffer significant healthcare disparities. Prospective trials have shown similar outcomes with partial and radical nephrectomy among patients with localized RCC (Van Poppel et al Eur Urol 2011), and multiple studies suggest increasing use of the former technique (Breau et al Can J Urol 2020). We hypothesize that patients from minority groups, as well as those with non-private insurance, will have less access to this specialized procedure and therefore have a higher rate of radical nephrectomy. Methods: We utilized the California Office of Statewide Health Planning and Development (OSHPD) database that collects information from all inpatient admissions, emergency room visits and inpatient/outpatient procedures in the state. All patients undergoing nephrectomy (both partial and radical) were identified from Jan 1, 2012 to Dec 31, 2018 using CPT and ICD-9/10 codes to identify patients. Demographic data was collected with specific attention to race and payor status. Univariate and multivariate analyses were conducted to determine the association between demographic data and procedure type. Results: In total, 31,093 patients were identified; 57% were males, with a mean age of 58 years. Among these, 16,142 (51.9%), 8,645 (27.8%), 2,795 (9.0%), 2,032 (6.5%) and 1,479 (4.8%) were characterized as White, Hispanic, Asian, Black and other, respectively. Partial nephrectomy and radical nephrectomy were performed in 15,840 (50.9%) and 15,253 (49.1%) of patients. By race, partial nephrectomy was performed in 8,576 (53.1%), 4,107 (47.5%), 1,286 (46.0%), 1,124 (55.3%) and 747 (50.5%) of White, Hispanic, Asian, Black and other patients, respectively (p<0.001). Use of partial nephrectomy also differed among patients based on payor status, with rates of 6,800 (56.4%), 5,036 (43.9%), 1,817 (38.3%) and 2,187 (77.7%) among patients with private, Medicare, indigent coverage (e.g., MediCal or Medicaid) and other insurance, respectively (p<0.001). On multivariate analysis controlling for age, gender, comorbidities and frailty, race was independently associated with type of nephrectomy procedure. Conclusions: Our study confirms that race and payor status may have an influence on utilization of partial versus radical nephrectomy, with the highest rate of partial nephrectomies among Whites and patients with private insurance. Although there are multiple potential confounders (e.g., latency of diagnosis and resulting tumor size/complexity), it is possible that access to care may be an important driver of these disparities.

Journal of Clinical Oncology, Feb 20, 2023

Clinical Genitourinary Cancer, May 1, 2023

European Urology, Jul 1, 2018

Journal of Clinical Oncology, Jun 1, 2023

Objectives: The prevalence of urinary incontinence (UI) in women in Slovakia is about 240 000 cas... more Objectives: The prevalence of urinary incontinence (UI) in women in Slovakia is about 240 000 cases and has an increasing trend. Only 5 % of them were diagnosed by visiting urology or gynecology outpatient department. The objective of this paper was to find out the level of QoL in women with UI in Slovakia. MethOds: The primary method used for the analysis of QoL was the combined questionnaire consisting of 6 parts: A. Demography (9 items), B. Clinical part (B1-International Consultation on Incontinence (ICIQ-SF): 4 items, B2-characteristics of UI: 23 items), C. Quality of life with dominant numeric scale (13 items), D. Socioeconomic part (9 items), E. EQ-5D (5 items), F. Symptoms of disease (9 items). There were 112 patients in the examined group from the160 asked to fill the questionnaire. The average age was 61 years. Results: Present level of QoL was identified as 6,60 on the scale from 1 to 10 (1-the worst,10-the best), while in the time of the UI diagnosis it was 5,10. QoL was 8,10 in the time without UI and 9,40 in the total optimal state of health. Comparative to the QoL was examined the ability to work (AW), too. Present level of AW was identified as 6,50, while in the time of the BC diagnosis it was 5,50. AW was 8.20 in the time without UI and 9,40 in the total optimal state of health. The impact of treatment on QoL was 7,60 and the disease had impact 7,40 on family QoL. The average income was 465,04 € and the willingness to pay for 1 month of complete health was in average 391,06 €. cOnclusiOns: The disease had a significant impact on patients´s QoL. The treatment of UI had a significant impact on increasing QoL of patients.

Clinical Genitourinary Cancer, Jun 1, 2023

Oncologist, Mar 14, 2023

Background: There is a lack of consensus regarding the optimal method of assessing health-related... more Background: There is a lack of consensus regarding the optimal method of assessing health-related quality of life (HR-QOL) among patients with metastatic renal cell carcinoma (mRCC). This study explored the perceived relevance of items that make up the Functional Assessment of Cancer Therapy Kidney Symptom Index-19 (FKSI-19), as judged by patients with mRCC. Methods: This was a multinational cross-sectional survey. Eligible patients responded to a questionnaire composed of 18 items that assessed the perceived relevance of each item in the FKSI-19 questionnaire. Open-ended questions assessed additional issues deemed relevant by patients. Responses were grouped as relevant (scores 2-5) or nonrelevant (score 1). Descriptive statistics were collated, and open-ended questions were analyzed and categorized into descriptive categories. Spearman correlation statistics were used to test the association between relevance and clinical characteristics. Results: A total of 151 patients were included (gender: 78.1 M, 21.9F; median age: 64; treatment: 38.4 immunotherapy, 29.8 targeted therapy, 13.9 immuno-TKI combination therapy) in the study. The most relevant questions evaluated fatigue (77.5), lack of energy (72.2), and worry that their condition will get worse (71.5). Most patients rated blood in urine (15.2), fevers (16.6), and lack of appetite (23.2) as least relevant. Qualitative analysis of open-ended questions revealed several themes, including emotional and physical symptoms, ability to live independently, effectiveness of treatment, family, spirituality, and financial toxicity. Conclusion: There is a need to refine widely used HR-QOL measures that are employed among patients diagnosed with mRCC treated with contemporary therapies. Guidance was provided for the inclusion of more relevant items to patients' cancer journey.

Cancer Cell, Nov 1, 2020

Countries in Latin America and the Caribbean have become hotspots of the novel coronavirus (COVID... more Countries in Latin America and the Caribbean have become hotspots of the novel coronavirus (COVID-19) pandemic, exacerbating socioeconomic inequalities and overwhelming fragmented health systems. Studies from the United States and Europe have highlighted the disproportionate effects of COVID-19 on patients with cancer and the disruption it has caused on cancer care delivery. The HOLA COVID-19 Study aims to understand how cancer care in Latin American countries has been affected by the COVID-19 pandemic. Main Text Background Since January of 2020, reports of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), also known as the novel coronavirus causing COVID-19, have emerged in the United States (US) and all around the world. As providers, we continue to see the severe negative impacts that the infamous COVID-19 has caused throughout the US. However, data on the impact of COVID-19 in Latin American countries are limited and continue to slowly emerge. In June, there had been approximately 4 million cases of COVID-19 in Latin America and the Caribbean, with over 27% of the estimated world's COVID-19 deaths occurring in the region (Dong et al., 2020; Johns Hopkins Coronavirus Resource Center, 2020). By September 2020, the number of cases in Latin America continued to increase, with Brazil alone surpassing the 4 million number of COVID-19 cases and with five Latin American countries being among the top ten countries with the highest number of cases worldwide (Johns Hopkins Coronavirus Resource Center, 2020). Unfortunately, Latin American countries also lead in the number of new deaths from COVID-19 worldwide and comprise one of the worst-hit areas in the world. With a wide variation across countries, the two most populous nations in the region, Brazil and Mexico, have seen the highest number of deaths, with Brazil having the second-highest death toll in the world after the US (Dong et al., 2020; Johns Hopkins Coronavirus Resource Center, 2020). Data from across the US suggest that, when compared to their non-Hispanic white counterparts, ethnic and racial minority populations have higher tendencies of contracting COVID-19 and are at higher risk for severe complications, including death. Particularly, Hispanic/Latinx patients in the US are nearly twice as likely to die from COVID-19 when compared to non-Hispanic whites (Gross et al., 2020). Multiple factors contribute to these disparities in the Hispanic/Latinx population, including barriers to testing and access to specialized care. It is also important to mention that Hispanic/Latinx people represent a large proportion of essential workers in the US and commonly live in crowded housing, factors that place them at higher risk for infection and make the adoption of

Europe PMC (PubMed Central), 2017

Journal of Clinical Oncology, Jun 1, 2023

Cancer Research, Jun 15, 2022

Journal of Clinical Oncology, Feb 20, 2022

Journal of Clinical Oncology, Feb 20, 2021

Journal of Clinical Oncology, Feb 20, 2022

Journal of Clinical Oncology, Oct 1, 2021

Journal of Clinical Oncology, Jun 1, 2023

Journal of Clinical Oncology, Feb 20, 2023

Clinical Genitourinary Cancer, May 1, 2023

European Urology, Jul 1, 2018

Journal of Clinical Oncology, Jun 1, 2023

Clinical Genitourinary Cancer, Jun 1, 2023

Oncologist, Mar 14, 2023

Cancer Cell, Nov 1, 2020

Journal of Clinical Oncology, 2018

Background: Depression and anxiety are highly prevalent in patients (pts) with genitourinary tumo... more Background:
Depression and anxiety are highly prevalent in patients (pts) with genitourinary tumors, including UC (Yang et al PLoS ONE 2016). Given that mUC has a high rate of somatic genomic alterations (GAs), we sought to determine if tumor mutational burden (TMB) or specific alterations were related to the incidence of these psychiatric disorders.
Methods:
From a single institution, we identified consecutive pts with mUC who had comprehensive genomic profiling done in the course of routine clinical care. In a CLIA-certified laboratory, DNA was extracted from 40 microns of FFPE sections. Hybridization-captured, adaptor ligation based libraries were used to a mean coverage depth of 718X for up to 315 cancer-related genes plus introns from up to 28 genes frequently rearranged in cancer. TMB was estimated based on the cumulative number of GAs. ICD-9 diagnoses corresponding to adjustment disorder (309.28), anxiety (300) and depression (311) were derived from detailed chart review, including review of established diagnoses and medication history.
Results:
A total of 43 pts (74.4% M / 25.6% F) were assessed with a median age of 65.5 (range, 49-81). Formal diagnoses of adjustment disorder, anxiety and depression were noted in 16.3%, 9.3% and 7.0% pts, respectively. An average of 6.3 GAs/pt (range, 0-14) were observed over the entire cohort. The rate of GA was higher in pts with anxiety vs adjustment disorder or depression (8.5 vs 6.8 or 4.0, P=0.01). No significant difference was observed in adjustment disorder or depression based on the frequency of GAs. GAs in BAP1, PIK3CB, NOTCH1, ALK, CDH1 and FANCC were noted to be associated with higher rates of anxiety (P=0.02). Similarly, GAs in FGFR1 was noted to be associated with higher rates of depression (P=0.002) and in CHEK2 in depression and adjustment disorder (P=0.03).
Conclusions:
Our study represents the first pyschogenomic analysis of pts with mUC. While higher TMB has been associated with favorable prognosis (Isharwal et al EU Focus 2017), we paradoxically found this to be related to higher rates of anxiety. Our findings suggest that genomically selected subsets of patients may be prime candidates for early psychosocial screening and intervention.

Journal of Clinical Oncology, 2018

Background: A correlation between depression/anxiety and survival has been established in patient... more Background:
A correlation between depression/anxiety and survival has been established in patients (pts) with mRCC (Cohen et al PLoS One 2012). We hypothesize that frequently encountered genomic alterations (GAs) in mRCC may identify pts with these psychological disorders.
Methods:
Data was obtained from pts with mRCC who received ctDNA profiling as a part of routine clinical care at progression using a CLIAA-certified platform evaluating 73 genes. Genomic alterations (GAs) were pooled for the entire cohort. ICD-9 diagnoses corresponding to anxiety and depression (300 and 311, respectively) were derived from detailed chart review, including review of established diagnoses and medication history. The chi-square test was used to determine the association between frequent GAs (those occurring in ≥5% of the study population) and the presence of depression and anxiety.
Results:
ctDNA results from 52 pts with mRCC were assessed (gender: 69.2% M, 30.8% F; average age: 58; histology: 84.6% clear cell, 15.4% non-clear cell). The most commonly used 1st-line treatment was sunitinib (46.1%). GAs were detected in 55.8% of pts. The most frequent GAs in the overall cohort included TP53 (21.1%), VHL (17.3%) and EGFR (7.7%). 5 and 8 pts were coded as having depression and anxiety, respectively. The average number (range) of ctDNA alterations detected was 1.1 (0-4) in patients with depression/anxiety and 1.6 (0-10) in those without (P = 0.001). The presence of VHL mutation was found to occur exclusively in pts with no depression/anxiety (P = 0.05), while 13 patients (25%) lacking VHL GAs had these psychological disorders.
Conclusions:
The absence of VHL alterations have been associated with poorer survival in pts with RCC (Patard et al Int J Cancer 2008), and our findings suggest that these patients may further have higher rates of depression/anxiety. Our data imply that patients bearing mutations in VHL may a prime target for early psychosocial interventions.

Journal of Clinical Oncology, 2018

Background: A joint survey was developed by the EAU RCC Guidelines Panel and KCCure, a non-profit... more Background:
A joint survey was developed by the EAU RCC Guidelines Panel and KCCure, a non-profit patient advocacy group, to ascertain patient perceptions towards adjuvant therapy for RCC (Battle D et al ASCO GU 2018). This survey included open-ended questions pertaining to sources of frustration in cancer-related care, the results of which are summarized herein.
Methods:
An online survey was conducted from April to June, 2017, publicized through social media and patient networking platforms. The survey obtained basic clinicopathologic, treatment related information, and open-ended questions asking for common sources of frustration in cancer-related care. Patients were also asked how they might reconcile these sources of frustration. Each response was analyzed and categorized into descriptive categories. The Kruskal-Wallis test was used to define associations between baseline characteristics and sources of frustration.
Results:
Among 450 patients with RCC, median age was 56, and 56% were female. The majority was diagnosed with clear cell histology (85%) and most patients had non-metastatic disease (73%). The most common sources of frustration were related to poor communication (20%), lack of confidence in diagnosis (18%), fear of recurrence/progression (14%) and financial issues (9%). Practical sources of frustration (e.g., lack of information, financial issues) were more common among patients with non-clear cell histology (P = 0.05) and older age (P = 0.01). In contrast, emotional sources of frustration (e.g., fear of recurrence/progression) were more common in females (P = 0.001). Patients posited that care could be improved if physicians demonstrated greater compassion (21%), spent more time supplying information (20%) and if they could circumvent financial issues (11%).
Conclusions:
RCC patients have varied and multiple concerns around care delivery. Based on this findings, practitioners should aim to better inform patients and should be cognizant of psychosocial issues surrounding their care. Certain baseline characteristics (age, gender and histology) can be considered in individualizing care delivery to minimize patient frustration.

Pediatric Blood & Cancer, 2017

Background/Objectives: A cancer diagnosis can negatively affect the biopsychosocial functioning o... more Background/Objectives: A cancer diagnosis can negatively affect the biopsychosocial functioning of adolescents and young adults (AYA).This study aims to describe levels of, and relationships between, distress and biopsychosocial unmet needs in a sample of Brazilian AYA patients with cancer.
Design/Methods: A study was conducted among 122 AYA patients with cancer aged 18 to 35 years, treated at a Brazilian public hospital. They were assessed using the Distress Thermometer, the Hospital Anxiety and Depression Scale and the Functional Assessment of Cancer Therapy - General. Descriptive statistics were obtained for all measures, item level frequencies were examined to identify common unmet needs and relationships between distress and unmet needs were explored.
Results: AYA patients were mostly were male (50.8%), single (54.1%), white (52.5%), diagnosed with, central nervous system (31.1%), hematologic (23%) or genitourinary (15.6%) cancers, at an advanced disease stage (41.8%). AYA reported greater distress (50%), being commonly related to practical (60.7%), emotional (73.8%) and physical (86.1%) problems. Financial (32%), worry (56.6%), nervousness (50%), sadness (31.1%), pain (47.5%), fatigue (39.3%), memory concentration (35.2%), and sleep (32%)were the highest scored. However, 25.4% reported clinical symptoms of anxiety and 9.8% of depression. AYA patients reported poor levels of quality of life that is at 50th percentile of the US norm.
Distress, symptoms of anxiety/depression and quality of life were significantly associated with biopsychosocial problems reported (p<.001). Higher levels of distress was predicted by symptoms of anxiety (B=0.2; p<.001), depression (B=0.2; p<.001), emotional (B=0.8; p<.001) and physical (B=0.3; p<.01) problems.
Conclusions: Brazilian AYA patients reported high levels and numbers of unmet needs and substantial distress. Strong associations were found between increased distress and more unmet needs. Findings suggest the need for psychosocial intervention for Brazilian cancer patients that target helping them cope with biopsychosocial distress. Further, this preliminary data highlight opportunities to re-orientate services to better meet AYA needs.

Annals of Oncology, 2017

Background: Patients with advanced cancer experience symptoms that include pain, fatigue, and dep... more Background: Patients with advanced cancer experience symptoms that include pain, fatigue, and depression. We sought to describe prevalence and identify factors associated with biopsychosocial distress in older patients (65+) diagnosed with cancer stage IV.
Methods: Participants were recruited from two different types of health care facilities, public [PUB] and private [PRI] institutions, in Brazil. A cross-sectional analysis of common biopsychosocial symptoms (anxiety, depression, pain, and fatigue), and quality of life reported by older patients undergoing chemotherapy treatment was performed.
Results: Older patients (n=167) were enrolled (Mean age=73; SD=5.6); 59.3% from PUB. Majority were female (56.3%; 38.9% PUB), white (68.9%; 35.7% PRI, p<.01), married (59.3%; 32.1% PUB, p<.01); and diagnosed with GI (29.9%; 15.8% PUB), GU (16.2%; 4.9% PUB), and hematologic (13.8%; 7.5% PRI) cancers. Almost 16% of patients reported depression symptoms (9.6% PUB) and 12% of anxiety (8.4% PUB). PUB patients also reported associated lower QOL, which is at 50th percentile of the US norm (PRI is at 75th percentile). PUB patients reported significantly more biopsychosocial problems including distress (21.6% vs 7.2%), pain (28.1% vs 12.0%), fatigue (34.7% vs 16.8%), sleep (22.8% vs 15%), neuropathy (22.8% vs 8.4%), and financial toxicity (16.2% vs 5.4%), compared to patients treated at PRI (all p<0.05). Mostly pain (B=1.8; B=-6.6), fatigue (B=0.8; B=-6.5) and sleep (B=1.2; B=-8.3) were associated with moderate to severe distress and worst QOL (all p<.01).
Conclusion: Older patients with late-stage cancer in Brazil suffer substantial unrecognized morbidity which impacts their distress and QOL. Biopsychosocial screening for older patients should be included in quality cancer care. Moreover, patients treated within PUB show worse outcomes than PRI counterparts, and they are at higher risk for multiple physical, psychological, and financial morbidity. Earlier initiation of biopsychosocial screening with appropriate supportive care may improve their QOL.

Annals of Oncology, 2017

Background: Depressive symptoms have been associated with poorer OS in pts with mRCC (Prinsloo et... more Background: Depressive symptoms have been associated with poorer OS in pts with mRCC (Prinsloo et al J Behav Med 2015). In other malignancies, BPSD has also been linked to poorer OS, but in mRCC, this association is unclear. Methods: From a single institution, clinicopathologic information from pts with mRCC diagnosed between 2001 and 2016 were collected. Corresponding data from an electronic survey tool was obtained, comprised of 22 core items spanning physical, practical, functional and emotional domains. Each item was self-assessed by the pt on a 5-point Likert scale. The cumulative score was used to characterize BPSD as either as low BPSD (not a problem/mild) vs high BPSD (moderate/severe/very severe). Associations between BPSD level and clinicopathologic criteria (e.g., Heng risk) were interrogated, and OS was compared between patients characterized as low BPSD vs high BPSD. Results: A total of 102 pts (28.4 % F/71.6% M) were assessed with a median age of 63 (range, 24-80). 73.4 and 26.6% pts were characterized as having good/intermediate and poor risk by Heng criteria, respectively. 79.3% pts and 20.7% pts were characterized as having low and high BPSD, respectively. No association was found between BPSD and age or gender. However, married patients have a longer survival (48.65 mos vs 34.52 mos, P=.07). Pts with poor risk mRCC were noted to have a higher BPSD as compared to pts with mild BPSD (75% vs 25%, P=.22). Median OS in the overall cohort was 44.2 months (mos). Although not statistically significant, a trend towards prolonged OS in pts with low BPSD vs high BPSD was observed (45.81 mos vs 35.95 mos, P=.81). Conclusions: Our study suggests a potential link between Heng risk and BPSD, and further shows a compelling trend towards poorer OS in pts with higher BPSD. These results warrant confirmation in larger series. Targeted interventions to address elements related to BPSD have the potential to improve patient outcomes and should be developed.

Psycho-Oncology, 2017

As global cancer incidence is increasing with well documented poorer outcomes, cancer is receivin... more As global cancer incidence is increasing with well documented poorer outcomes, cancer is receiving increasing attention in Latin America and the Caribbean. Due to the urgency of the cancer burden in developing countries (LMIC) where mortality ranges from 50‐90% compared to the 20‐40% range for developed countries (except for lung cancer), we are compelled to ask provocative questions and cultivate innovative best approaches in research and practice for more rapid translation of new knowledge and implementation of interventions to bring whole person cancer care and reduce the undue burden of cancer in this region. Further, mounting evidence directs our attention to the social determinants of cancer outcomes. Yet, there are several challenges in examining broad social contexts requiring the inclusion and guidance of survivor‐advocates. This symposium will discuss survivorship outcomes and survivorship care development within the Caribbean region focusing on two specific nations Brazil and Trinidad and Tobago. Our findings indicate high cancer related societal and survivor burden. The health care systems in LMIC countries are overwhelmed with the increasing cancer incidence. Multilevel factors including socioeconomic status, quality of care, distress screening and management seem to be associated with patient outcomes. Developing psychosocial and supportive care in developing countries involve the engagement of multisectorial stakeholders including civil society, government, healthcare system, clinicians, advocates and patients. The need to develop these cancer care components is urgent and compelling.

Psycho-oncology, 2017

Cognitive Impairment has been frequently reported by breast cancer survivors (BCS). However, to o... more Cognitive Impairment has been frequently reported by breast cancer survivors (BCS). However, to our knowledge no study has beed previously conducted with Brazilian cancer patients. This pilot study attempted to explore the self‐reported cognitive function, considering the most common physical and psychosocial symptoms described in the literature. BCS were recruited from a Breast Cancer Outpatient Clinic of Brazilian public hospital. They were assessed by the Functional Assessment of Cancer Therapy—General and Cognitive Function (FACT‐G and FACT‐Cog), Distress Thermometer (DT) and Hospital Anxiety and Depression Scale (HADS). This pilot sample was composed by 13 BCS who were on average 50.4 (SD = 7.4) years old and 35.4 (SD = 8.1) months posttreatment. The Cognitive Function (M = 108.5, SD = 31.6) was significantly correlated with quality of life, anxiety/depression, fatigue, and sleep. The same was observed with the subscales Perceived Cognitive Impairment (M = 59; SD = 17.5), Comments from Others (M = 14.9; SD = 1.7) and Perceived Cognitives Abilities (M = 22.7; SD = 9.8). From this preliminary data, it was possible to note that the cognitive symptoms are also an issue for Brazilian BCS, with a significant impact on their life. Is was also observed that this late symptom has been poorly discussed among our health team, and probably being unrecognized and untreated. This study is ongoing, towards the implementation of effective evidence‐based supportive care practice to enhance BCS outcomes.

Psycho-Oncology, 2017

Inequalities exist between healthcare systems in Brazil. Understanding patient‐reported outcomes ... more Inequalities exist between healthcare systems in Brazil. Understanding patient‐reported outcomes provide valuable information to guide health services and clinical practice. We aimed to characterize distress in cancer patients treated at private or public service. 1211 cancer patients (52.1% from public service) were assessed for distress during the chemotherapy. Descriptive statistics and logistic regression models adjusted for potential confounders were used. The most commonly endorsed sources of distress by patients treated at public and private services were finances (39.5% vs 19.5%), anxiety (40.4% vs 35%), sadness (41.2% vs 43.1%), worry (54.2% vs 49.1%), fatigue (55.9% vs 46.9%), pain (49% vs 24.1%), sleep (44% vs 49.3%), and nausea (26.8% vs 34.3%). The logistic regression model was statistically significant. Female patients were 1.23 times more likely to report distress. Decreasing age and being treated at a public service were associated with and increased likelihood of exhibiting distress. Marital status and race were not significantly associated with distress. Patients reported disparate levels and sources of distress. Patients from public hospital, and who are also lower socioeconomic status, were 20% more likely to be diagnosed with advanced disease and 50% more likely to reported pain. Importantly, early integration of palliative care seems urgent especially with the public health system. Further investigation on access to care leading to disparities are needed to address the unequal burden of cancer.

Psycho-Oncology, 2017

Evidence supports the early integration of palliative care in oncology setting. We sought to desc... more Evidence supports the early integration of palliative care in oncology setting. We sought to describe rates of distress in patients diagnosed with incurable cancer and identify factors associated with these symptoms. A cross‐sectional analysis of data from patients diagnosed with cancer stage IV, undergoing chemotherapy treatment at two cancer settings (public and private), was performed. It was enrolled 468 patients (61.8% public hospital). Most of them were female, white, married and diagnosed with GI and breast cancers. A greater proportion of patients from public hospital reported significantly more distress (44.6%vs 23.5%) and anxiety symptoms (22.1%vs 12.8%). However, the proportion of patients reporting depressive symptoms (17.3% vs 16.8%) did not significantly differ. Patients from public hospital tends to report significantly more financial (38.4% vs 16.8%), transportation (15.9% vs 2.2%), breathing (30.8% vs 11.2%), fatigue (60.2% vs 45.8%), and pain (52.9% vs 30.7%). Pain (B = 1.4), fatigue (B = 1.2) and breathing (B = 1.6) were associated with distress (ps < .001). Our findings highlight the substantial emotional morbidity experienced by patients at stage IV and also emphasize the benefit from targeted palliative care and psychosocial interventions. Patients treated at a public setting is at particularly risk for distress. Earlier intervention in patients' disease course may prevent ongoing burden and enhance their ability to cope with their disease.

Psycho-Oncology, 2017

Distress should be assessed as part of routine cancer care. Considering the lack of resource in d... more Distress should be assessed as part of routine cancer care. Considering the lack of resource in developing countries and the international evidence, a biopsychosocial screening routine was implemented in distinct health care systems in Brazil, supported by a NCI R25‐E training program. We sought to provide an overview of the development and implementation of these programs and report initial results to extend international research. The training program guided on effective biopsychosocial screening implementation strategies, which was translated and applied at a public (low levels of education/income) and at two private settings in Brazil. A study was implemented to establish the prevalence of patient distress. A total of 1262 patients who were undergoing chemotherapy were recruited. The majority was female, diagnosed with GI and breast cancers at an advanced disease stage. The prevalence of moderate to severe distress was higher among patients from public hospital (41.2% vs 26.9% and 19.1%). Patients tended to report more emotional and physical symptoms with a small difference on the prevalence between cancer settings. However, differences emerged in the types of problems reported, which may have implications for the structure of supportive care in these settings. These findings provided evidence that a biopsychosocial screening program is feasible in a developing country. This screening assisted thousands of patients with psychosocial concerns, focusing on their needs. This training directly impacted the quality of clinical care provided at each institution.

Psycho-Oncology, 2017

Testicular cancer (TC) accounts for less than 1% of all male cancers. Despite a good prognosis, t... more Testicular cancer (TC) accounts for less than 1% of all male cancers. Despite a good prognosis, the typically young age at diagnosis and physical sequelae may cause distress in survivors. This study aims to explore the prevalence of distress in TC survivors. Men previously diagnosed withTC receiving routine follow‐up care at a Brazilian Public Hospital were assessed for distress and anxiety/depression. A total of 26 patients participated (50% seminoma), with a mean age of 28.9, and the majority married and white. The survival rate was 50.8 months, 73.1% of patients received the BEP (2‐3 cycles) and 96.2% had an orchiectomy. Clinically significant symptoms of anxiety/depression was found in 7.7% of patients. However, 53.8% of non‐seminoma and 30.8% of seminoma reported high distress. Worry (53.8%), nervousness (30.8% vs 38.5%), fatigue (15.4% vs 46.2%), memory (38.5% vs 30.8%), pain (23.1% vs 38.5%), sex (23.1% vs 7.7%), sleep (15.4% vs 23.1%) and appearance (15.4%) were the most common problems reported. These findings suggest high rates of distress among long‐termTC survivors; however the majority possessed sub‐syndromal symptomatology and relatively few reported diagnosable symptoms of anxiety or depression. Distress may be associated with fear of recurrence and possible long‐term side effects. These data suggest a role for supportive care in assisting patients with TC in managing distress throughout the cancer continuum.

Background: The Quality Oncology Practice Initiative (QOPI) provides a standardized approach to a... more Background: The Quality Oncology Practice Initiative (QOPI) provides a standardized approach to assessing performance on a series of evidence- and consensus-based process measures in oncology. In 2015, the QOPI was utilized in a large oncology practice in Brazil to provide a baseline assessment, identify practice deficiencies and guide improvements. Feedback was provided to the oncology team and specific actions identified. This study reports the results of the follow-up QOPI assessment 2 years after the initial baseline was recorded. Methods: From data obtained in 2015 instructions were established for the documentation of physical and psychological symptoms, and of diagnosis and treatment discussions with patient, side effects and infertility risk, informed consent, and genetic services. No significant differences were found in the sociodemographic and clinical characteristics of the patient cohorts. Results: There was an overall increase in performance (60.6% to 77.1%; p < .01). Elements of medical care and of cancer management still consistently and appropriately documented (e.g., pathology, stage, and treatment). There were a significant improvement in performance on measures related to pain assessment (59.5% to 84.5%), and symptom/toxicity management (62.3% to 91.2%). Relatively poor performance persisted however, most notably in the assessment of patients’ psychosocial status (26.5%), discussion of treatment goals (45.6%) and fertility risks (7.4%). Informal feedback was garnered from team concerning areas of ongoing deficiency. Conclusions: There was a significant improvement in adherence to QOPI indicators. Performance in a number of domains remained relatively poor, despite clinical efforts. The reasons are likely multifactorial; and may include a lack of specific resources in a public service (e.g., absence of a fertility service), clinician-based factors that can be culturally driven (e.g., discomfort discussing prognosis), and inconsistent chart documentation. The QOPI provides important guidance in improving oncology care, with the current study suggesting a need for training on psychosocial assessment, as well as the role of an EMR system in ensuring appropriate documentation.

Background/Purpose: Cancer during pregnancy can present complex and traumatic concerns. Little re... more Background/Purpose: Cancer during pregnancy can present complex and traumatic concerns. Little research has explored the impact of these two major life-changing events. We sought to explore the experience of gestational breast cancer patients (GBCP) and identify unique challenges GBCP are facing, compared to not pregnant breast cancer patients (BCP).

Methods: A cohort study compared data from GBCP (n=6) and BCP (n=46), undergoing the same treatment at a Brazilian public hospital. Measures included the DT, HADS and FACT-G. GBCP also completed a semistructured interview.

Results: GBCP reported lower levels of distress, anxiety/depression and better QoL than BCP. The content analyses revealed that GBCP discovered their pregnancy weeks after their diagnosis. Fears were related to risk of miscarriage or potential harm of treatment to the unborn baby. Ultrasonography helped to monitor baby’s health and to lessen anxiety. After the first chemotherapy infusion, 83.3% turned their focus to their baby. One patient reported increased distress associated with smoking cessation efforts. Other preferred to minimize social contact and avoided celebrations until their baby's healthy birth. Health care providers was essential and helped them to address issues regarding baby’s health and well-being.

Conclusions: Unexpectedly, our preliminary findings suggest that GBCP experience less psychological turmoil than BC. It is possible that pregnancy provides a sense of meaning and a broader perspective for women diagnosed with cancer, possibly through the focus given to ensuring the health of their unborn child. Future studies should explore the long-term impact of GBCP.

Background/Purpose: Rare cancers are a heterogeneous group of conditions that can be associated w... more Background/Purpose: Rare cancers are a heterogeneous group of conditions that can be associated with unmet medical needs and poorer quality of life (QOL). Despite this, and because of their rarity, sufferers remain a poorly understood group from the vantage of psychosocial concerns and QOL. Our main goal was to explore psychosocial outcomes reported by patients diagnosed with a rare form of cancer.

Methods: Data from 31 patients (64.5% female; M=51.32 of age) diagnosed with a rare cancer (74.2% at late disease stage) and treated at a Brazilian public hospital were evaluated for distress (DT), anxiety/depression (HADS) and QOL (FACT-G). All patients previous knew that their diagnostic was rare. Descriptive statistics and correlations between variables assessed were generated.

Results: 48.4% patients reported high distress levels, with 32.3% endorsing anxiety and 25.8% depression. A low mean QOL score was found (at 25th percentile of the US norm), with emotional and functional well-being the most impaired subscales. Statistically significant correlations were identified between distress, anxiety/depression and QOL (p<.01). The most concerns were nervousness (71%), worry (71%), pain (64.5%), sadness (51.6%) and fatigue (51.6%).

Conclusions: Patients reported poorer psychosocial outcomes and impaired QOL when compared to normative data, suggesting that this patient population may be at elevated risk. A rare cancer diagnosis can be traumatic and prompt anxiety and uncertainty. Given their rarity, limited disease specific support groups or counseling exists, thus potentially invoking feelings of isolation. Further research should be conducted to investigate psychosocial aspects and possible interventions targeting this poorly understood group.

Background/Purpose: Studies have shown a clear difference among minority and economically disadva... more Background/Purpose: Studies have shown a clear difference among minority and economically disadvantaged patients. Less is known about marginalized populations in Brazil, a country that possesses a two-tiered healthcare system, based on socioeconomic status. We sought to explore differences in quality of life (QOL) and distress among patients receiving care within these systems.

Methods: 270 patients were assessed for distress (DT), anxiety/depression (HADS) and QOL (FACT-G). Half of them was recruited at a private institution (PRI) and the other at a public institution (PUB) (each group: n=135; 68.9% breast and 31.1% gynecological cancers). We calculated descriptive statistics and examined QOL and distress using T-test and ANOVA.

Results: We found ethnic differences between PUB (50.4% white, 32.6% mulato and 14.1% black) and PRI patients (82.9% white), and income disparities (PUB patients report almost a third less monthly income than PRI patients). PUB patients were mostly late-stage diagnosed 70.4% compared to PRI counterpart 42.2% (p<.001). In general PUB patients reported higher rates of distress and anxiety/depression (p<.03); and poorer QoL outcomes (p<.01).

Conclusions: This preliminary study is one of the first to investigate inequities in cancer outcomes among patients in Brazilian healthcare settings. Analyses revealed notable differences between groups across demographic characteristics, while individuals of lower socioeconomic status reported significantly poorer psychosocial outcomes. These results suggest a complex interaction between ethnicity, access to care and cancer outcomes, and warrants further research to better understand and address these inequities. Further discussion of the role of psycho-oncology research and clinical practice in reducing disparate outcomes among Brazilian cancer patients is warranted.

Background/Purpose: Distress and anxiety/depression are common psychological issues associated wi... more Background/Purpose: Distress and anxiety/depression are common psychological issues associated with a cancer diagnosis and its treatment, and can impair quality of life (QoL). Less is known about the experience of older adults diagnosed with cancer in developing countries, such as Brazil.

Methods: The participants included 315 cancer patients (65-89 years, M=72.5; 54% female), recruited at two Brazilian cancer centers. Patients were undergoing chemotherapy for gastrointestinal (27.9%), hematologic (22.2%) and breast (14.9%) cancer; 80% were at advanced disease stage. They were assessed using the DT, HADS and FACT-G.

Results: Approximately 22% of patients reported moderate to severe distress, 11.7% symptoms of anxiety and 14% of depression. Patients also reported associated impairments in QoL. On the problem list, 59.9% reported an average of 1.6 Emotional Problems, and 93% an average of 4.6 Physical Problems. Linear regression analysis identified depression, sadness, worry, fatigue, nausea, pain and sleep as predictors of distress; and sadness, nervousness, worry, loss of interest in usual activities, eating, fatigue, nausea, pain and sleep predicting worse scores at FACT-G.

Conclusions: A lower prevalence of distress among older patients was established in the current study, as well as higher rates of depression symptomatology compared to anxiety. The present findings also highlights a set of intersecting concerns among older patients, including sadness, worry, fatigue, pain and sleep; potential risk factors that should be considered as part of the psychosocial care routine. Further, it is possible that the screening program served as a tool to prompt discussion of psychological support services that may not have arisen organically due to stigma.