bluuebunny/crossref_metadata_2025 huggingface dataset:
A pilot study of intraneural facilitation versus standard physical therapy for prevention of chemotherapy-induced peripheral neuropathy.
Authors: Castillo Dan Ran , Jeon Won Jin , Lucero Carvy Floyd , Bussell Mark , Coleman Ron , Pieters Karla , Hankins Jamie , Boggs Annette , Dehom Salem , Garcia Lorena , D'Errico Ellen , Nagaraj Gayathri
Published: June 2023

12068

Background: Chemotherapy-induced peripheral neuropathy (CIPN) is a debilitating side effect necessitating chemotherapy (CT) dose adjustments or early termination. Intraneural Facilitation (INF) is a novel form of manual physical therapy (PT) developed to mitigate CIPN-related symptoms and improve patients’ functional outcome. We conducted a randomized pilot study evaluating the efficacy of INF vs. standard PT in the prevention of CIPN (NCT 03272919). Methods: Eligible participants were patients with newly diagnosed breast cancer (stages I-III) and gynecologic cancer without preexisting peripheral neuropathy planning to receive platinum-based and/or taxane-based CT. Participants were randomly assigned to either INF or PT arm and received two 45-minute treatments twice a week for six weeks during their CT course. Outcomes reported here are a) assessment of pain between the 2 arms using the Pain Quality Assessment Scale (PQAS), and b) measurement of vascular patterns using ultrasound (US), evaluating pulsatility index, volume flow and peak systolic velocity between the 2 arms. Participants were evaluated at baseline, week 3 (W3), week 6 (W6), and month 3 (M3). PQAS scores ranged from 0 to 10 with subscale evaluations of paroxysmal, surface, and deep pain. Pain scores on a scale from 0 to 10 were grouped into none (0), mild (1-3), moderate (4-6) and severe (7-10). The use of neuropathy medications, CT dose reductions, premature CT discontinuation and participant satisfaction surveys between the two groups were previously reported at SABCS 2022. Results: Of 104 screened participants, 44 met the eligibility criteria, with 38 eligible for analysis (n=20 INF arm and n=18 PT arm). Participants reporting moderate or severe pain in either arm were combined (Table). Pain symptoms peaked at W6 coinciding with cumulative CT effects. At M3, none in the INF arm reported moderate or severe paroxysmal pain compared to two participants in the PT arm. One participant in each arm reported moderate or severe surface or deep pain at M3. The US results showed physiologic impact in both arms at W3 and W6, suggesting their role in preserving neural tissue blood flow and reducing vascular damage. Conclusions: Our study shows fewer number of participants on both intervention arms reporting pain, with numerically lower scores on PQAS in INF arm compared to PT arm, especially during ongoing CT. The US results suggest that INF has a unique pathophysiological impact on the microvasculature compared to standard PT; further studies are needed to validate these findings and potentially address their clinical significance as a combined modality. Clinical trial information: NCT03272919 . [Table: see text]
The effect of exercise on physical function and medication adherence in women receiving endocrine therapy for breast cancer: The breast cancer endocrine therapy fitness (BE-FIT) randomized controlled trial.
Authors: Myers Samantha , LeVasseur Nathalie , Mackenzie Kelly , Fujita Rafael A. , Faulkner Guy , Berkowitz Jonathan , Olson Robert Anton , Trinh Linda , Campbell Kristin L.
Published: June 2023

12069

Background: Approximately 20% of women receiving endocrine therapy (ET) for early-stage breast cancer (BrCa) discontinue their regimen due to side effects, including vasomotor symptoms and arthralgias, subjecting them to higher rates of disease recurrence. Exercise is one approach to mitigate ET-related toxicity and potentially improve medication adherence by mitigating ET-related symptoms. However, only 11% of women with BrCa adhere to recommended exercise guidelines. Purpose: To examine the effect of a virtual supervised exercise program for women receiving ET for early-stage BrCa on physical function (PF) (primary outcome) and adherence to ET (secondary outcome). Methods: Participants were recruited through referral by oncology care providers from multiple BC Cancer sites and self-referral. Eligible participants were: females with stage I-III BrCa being treated with curative intent, 19-75 years, taking ET for at least 3 months up to 3 years. Using a partial cross-over design (NCT04824339), participants were randomized to the immediate exercise group (INT) or the delayed exercise group (CON), which crossed over at 8 weeks. The 8-week intervention was comprised of a 50-minute resistance exercise circuit, delivered virtually by an exercise physiologist twice per week via Zoom, and self-directed aerobic exercise (progressing to 90 minutes or more per week of at least moderate intensity). PF was assessed using the 30-second chair stand test. ET adherence was measured by the Voils self-reported medication non-adherence questionnaire. Values reported as means and standard deviations. The difference at 8 weeks by intervention arm was examined using two sample t-test (continuous) or kappa measure of agreement (categorical). Results: A total of 132 women were randomized. On average, women were 54 years, White (European) (47%), married (64%), had at least a bachelor’s degree or higher (51%), and had a body mass index of 27.7 kg/m2. The most common type of ET women received was Letrozole (43%), followed by Tamoxifen (36%). At 8 weeks, there was a significant improvement in PF for INT versus CON (mean change +2.5±2.9 vs. +0.7±2.2 stands, p< 0.001). There was no difference between groups in change in medication adherence status (k = 0.35). Conclusions: An 8-week virtual supervised exercise program for women receiving ET for early-stage BrCa significantly improved PF but did not change medication adherence at 8 weeks. The potential impact of the intervention on long-term medication adherence will be explored up to one year and with covariates. Based on improvement in PF, future trials to establish effectiveness and inform implementation are warranted. Clinical trial information: NCT04824339 .
Preliminary outcomes of a financial navigation program among lower socioeconomic patients with cancer.
Authors: Tan Chiu Yi Joey , Jacoby Jessica , Garber Greg D. , Leader Amy , Cammy Rebecca , Incudine Andrea , O’Brien Morgan , Cunningham Rosie , Stivers Thomas , Doherty Meredith
Published: June 2023

12071

Background: Cancer patients receiving treatment are at risk of experiencing financial hardship, especially among those from lower socioeconomic status (SES) households. Patients experiencing financial toxicity are more likely to report poorer physical-wellbeing, higher anxiety, housing or food insecurity, and treatment non-adherence. While financial navigation programs are present, there is a lack of standardized practice to mitigate financial hardship among cancer patients. The purpose of this study is to evaluate the preliminary efficacy of Family Reach’s oncology financial treatment program (FTP) on financial toxicity, quality of life, and anxiety in low SES patients. FTP consists of individualized resource navigation, financial education services, and a $1000 patient assistance grant that was used towards non-treatment related expenses. Methods: 152 cancer patients undergoing active treatment, with household incomes under the 400% poverty line were recruited from two NCI-designated cancer centers. 99 participants completed the baseline and 2-month follow-up survey, consisting of these measures: COST: A FACIT Measure of Financial Toxicity (COST), Hospital Anxiety and Depression Scale (HADS), 36-Item Short Form Health Survey (SF-36), poverty exposers and treatment adherence items (secondary outcomes). Results: Participants were 69% female; roughly half (51%) were African American/Black, 34% were white, 4% were mixed, 3% were Asian and 8% reported ‘other’ or preferred not to answer. COST score at baseline (M=10.5, SD=6.4) significantly increased after 2 months (M=12.9, SD=7.9), t(176.2)= -2.3, p<.05. HADS-Anxiety score at baseline (M=11.1, SD=4.7) significantly decreased after 2 months (M=9.2, SD=4.4), t(186.0)= 2.88, p<.01. SF-36 Physical functioning score at baseline (M=34.0, SD=27.2) significantly increased after 2 months (M=43.9, SD=31.0), t(170.3)= -2.26, p<.05. See Table for secondary outcomes. Conclusions: Early evidence of FTP indicates promising results to increase financial and physical well-being, and in reducing anxiety among lower SES cancer patients. FTP showed improvements in COST scores and reduced non-medical cost concerns. However, COST scores reported in this study are still lower compared to other studies. A planned future study involving monthly guaranteed income payments will be carried out to examine if financial well-being and treatment adherence can be achieved. Supported by: One Family Foundation/Social Impact Fund Secondary outcomes. [Table: see text]
Survivorship care and breast and cervical cancer screening.
Authors: Santos Teles Marco , Modugu Ganesh , Silva Isabel C. , Mattes Malcolm David , Eskander Mariam F.
Published: June 2023

12075

Background: Studies suggest that despite their history, cancer survivors may be equally or less likely to be screened for various cancers. The impact of the components of survivorship care on post-treatment screening is unknown. We aim to gauge the association of receipt of treatment summaries, follow-up care instructions (including where to obtain “routine cancer check-ups”), and type of doctor providing survivorship care on breast cancer screening (BCS) and cervical cancer screening (CCS) in female cancer survivors. Methods: A cross-sectional, retrospective analysis using Behavioral Risk Factor Surveillance System (BRFSS) survey data from 2016 and 2018 was conducted. BCS-eligible women were aged 40-74; CCS-eligible women were 30-64. BCS completion was defined as a mammogram within 2 years and CCS completion as a pap smear within 3 years or an HPV test within 5 years. Univariate analysis was conducted using chi-square. Multivariate logistic regression was used to determine which survivorship care factors were associated with BCS and CCS. Results: 4,533 BCS and 2,566 CCS-eligible survivors were identified. In the BCS-eligible group, 85.9% were aged ≥50, 89.7% were white, 62.5% had a degree beyond high school, 48.7% earned ≤$50,000, and 96.1% were insured. In the CCS-eligible group, 68.1% were aged ≥50, 87.9% were white, 63.7% had a degree beyond high school, 45.0% earned ≤$50,000, and 93.3% were insured. 82.0% were up-to-date (UTD) with BCS; 92.6% were UTD with CCS. BCS and CCS were higher for insured survivors (82.2% vs. 66.2%, p = 0.009; 93.8% vs. 83.3%, p = 0.013, respectively). 48.7% of BCS-eligible and 50.5% of CCS-eligible survivors received a treatment summary. 75% of BCS-eligible and 77% of CCS-eligible survivors received follow-up instructions. Among BCS-eligible survivors, recipients of treatment summaries and follow-up instructions were significantly more UTD with BCS than non-recipients (84.9% vs. 78.5% and 84.5% vs. 74.3%, respectively, p < 0.001). Among CCS-eligible survivors, recipients of follow-up instructions were significantly more UTD with CCS (94.5% vs. 88.9%, p = .021); there was no significant difference for recipients of treatment summaries (p = .201). In both groups, there was no significant difference in BCS or CCS based on the type of physician providing survivorship care (p = .732 and p = .098, respectively). On multivariate analysis, receipt of follow-up instructions was the only factor significantly associated with BCS (OR 1.46; 95% CI: 1.05–2.03) and CCS (OR 2.57; 95% CI: 1.19–5.55). Conclusions: Follow-up instructions, which are part of the survivorship plan, have the greatest association with BCS and CCS among cancer survivors. Despite this, about 25% of BCS and CCS-eligible cancer survivors did not receive them. Additional research should focus on improving the practice of survivorship care, particularly follow-up instructions, as a method to increase uptake of BCS and CCS among cancer survivors.
Estimating burden of cardiovascular disease among survivors of breast, colorectal, lung, and prostate cancer in the detroit research on cancer survivors (ROCS) cohort.
Authors: Nair Vidhya , Simon Michael S. , Barac Ana , Raychaudhuri Sreejata , Reding Kerryn , Cheng Richard , Ruterbusch Julie , Vasbinder Alexi , Beebe-Dimmer Jennifer Lynn
Published: June 2023

12082

Background: With new advances in cancer treatment, cancer-specific mortality has decreased by 31% over the past 3 decades. The growing number of cancer survivors has led to increased risk of other chronic conditions including cardiovascular disease (CVD), which has become an important competing cause of mortality. This study evaluates the incidence of CVD, including heart failure (HF), myocardial infarction (MI), coronary artery disease (CAD), atrial fibrillation (AF) and stroke after cancer in the Detroit ROCS cohort. Methods: ROCS is an African American cancer survivorship cohort that enrolled participants residing in the tri-county Detroit Metropolitan area. This study included survivors of breast, colorectal, lung, and prostate cancer who provided socio-demographic and clinic information on self-administered questionnaires. We calculated incidence as percentages and rates per 1,000 person-years of HF, MI, CAD, AF, and stroke after cancer. Multivariate logistic regression analysis was used to evaluate the relationship between socio-demographic and clinical predictors of CVD by using factors with p-value < 0.1. Results: After excluding patients with pre-existing CVD or lack of data on comorbidities, the study cohort consisted of 2,865 participants. The mean (SD) age at cancer diagnosis was 60.3 (9.4) years with median follow up of 3.0 (1.0-9.3) years. The incidence rate for any CVD was 23.3 per 1,000 person-years. In the study sample, stroke was the leading CVD, followed by HF, AF, CAD and MI. Lung cancer survivors had the highest incidence of CVD followed by prostate, breast, and colorectal cancer. Age at cancer diagnosis, household income, insurance, aspirin, smoking, body mass index, hypertension, diabetes, and high cholesterol were included in the final model. In the multivariate analysis, decreased household income [OR 1.26 (95% CI 1.05-1.52)], prior aspirin use [OR 1.83 (95% CI 1.34-2.49)], and history of hypertension [OR 1.71 (95% CI 1.20-2.44)] were associated with higher odds of CVD. Conclusions: CVD is a relatively common outcome within years after cancer diagnosis in an African American survivorship cohort. Intervention should focus on the possible impact of socioeconomic variables and control of hypertension in reducing the risk of CVD after cancer. [Table: see text]
Cardiac safety of reduced surveillance for cancer therapy related cardiac dysfunction in patients with breast cancer treated with HER2-targeted therapy.
Authors: Yu Anthony Francis , Dang Chau T. , Jorgensen Justine , Moskowitz Chaya S. , Wallins Joseph , DeFusco Patricia Anne , Oligino Eric , Oeffinger Kevin C. , Liu Jennifer , Steingart Richard
Published: June 2023

12083

Background: Non-anthracycline-based therapy is a treatment option for patients (pts) with HER2-positive breast cancer (BC) and is associated with lower risk of cancer therapy related cardiac dysfunction (CTRCD) compared to anthracycline-based treatment. Given the reduced CTRCD risk with non-anthracycline HER2-targeted therapies, updates to practice guidelines that recommend surveillance echocardiograms (TTE) every 3 months are needed. We evaluated the cardiac safety of reduced CTRCD surveillance in pts receiving non-anthracycline HER2-targeted therapies. Methods: Pts with BC treated with non-anthracycline HER2-targeted therapy were enrolled in this single-arm prospective study. Pts with previous anthracycline exposure, uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg), or significant cardiovascular disease were excluded. TTEs were performed at baseline, 6 months, and 12 months during HER2-targeted treatment. The primary endpoint was a cardiac event, defined by clinical heart failure (New York Heart Association Class III/IV) or cardiovascular death, with a prespecified non-inferiority margin of 2.9% relative to a cardiac event rate of 1.1% based upon prior studies. Secondary endpoints were CTRCD, defined by decline of left ventricular ejection fraction (LVEF) ≥10% to < 53%, and interruption of HER2-targeted treatment secondary to CTRCD. Results: Between May 2019 and January 2022, 190 pts (age 52 ± 11 y) with HER2-positive BC were enrolled: 143 (75%) had stage I disease, 8 (4%) had diabetes, 38 (20%) had hypertension, and baseline LVEF was 64 ± 5% (Table). Additional TTEs outside the prespecified 6- and 12-month timepoints were performed for 35 (18%) pts, of which 20 were to assess for possible cardiac symptoms. After 1-year follow-up, there were 0 (0%; 97.5% CI 0- 1.9%) cardiac events. Two (1.1%) pts developed CTRCD and 1 (0.5%) pt had a temporary CTRCD-related treatment interruption. Conclusions: Reduced CTRCD surveillance every 6 months is feasible and safe for selected pts with HER2-positive BC receiving non-anthracycline HER2-targeted therapy. Our findings support the need to update cardio-oncology practice guidelines and allow for less frequent surveillance TTEs among pts at low-risk for CTRCD. Clinical trial information: NCT03983382 . [Table: see text]
Training and validation of a model predicting clusters of long-term cancer-related behavioral symptoms (CRBS) after breast cancer (BC).
Authors: Pagliuca Martina , Havas Julie , Lerebours Florence , Rigal Olivier , Petit Thierry , Giacchetti Sylvie , Dalenc Florence , Wassermann Johanna , Arsene Olivier , Martin Anne-Laure , Everhard Sibille , Luis Ines Maria Vaz Duarte , Di Meglio Antonio
Published: June 2023

12087

Background: Fatigue, cognitive impairment, emotional distress, and sleep disturbance are prevalent and challenging symptoms among patients (pts) with BC. These symptoms often tend to cluster, they are usually responsive to similar behavioral interventions (e.g., exercise, psychosocial), and can be collectively defined as CRBS. We aimed to generate a model to predict clusters of long-term CRBS. Methods: CANcer TOxicity (CANTO; NCT01993498) is a prospective cohort of pts with stage I-III BC collecting longitudinal data at diagnosis (dx) and yearly post-dx. Our outcome was the proportion of pts reporting a cluster of ≥3 severe CRBS (EORTC QLQ-C30/HADS) 4 years post-dx. Clinical, behavioral, treatment (tx)-related predictors, and the baseline Behavioral Symptoms Score (BSS; based on the number of severe CRBS as proxy of symptom burden at dx) were tested in a training cohort (Mar 2012 - Feb 2015) with a multivariable logistic regression model implementing bootstrapped Augmented Backwards Elimination and 10-fold internal cross-validation. Performance was externally validated in pts from a subsequent enrolment period (Mar 2015 - Apr 2018). Results: In the training cohort (N=3555), 92.1% of pts had stage I-II BC, 52.6% received chemo, and 81.9% endocrine tx. At dx, 22.0% pts had severe fatigue (C30≥40/100), 29.7% severe cognitive impairment (C30<75/100), 33.9% and 6.5% clinically suggestive anxiety and depression (HADS≥11/21), respectively, and 35.2% severe insomnia (C30>50/100). 19.0% of pts reported a severe CRBS cluster at dx, then 21.0% did so 4 years post-dx. Younger age, previous psychiatric disorders, and higher baseline BSS were predictors of CRBS clusters (Table;AUC 0.73 [95%CI 0.71-0.75]). Results were confirmed in the validation cohort (N=1533). Conclusions: 1 in 5 pts reports a cluster of severe CRBS 4 years post-dx of BC. Younger pts with previous psychiatric disturbance and a higher symptom burden at dx have greater risk of long-term CRBS. Systematic clinical implementation of predictive tools at dx of BC can aid a more thorough screening and referrals to targeted behavioral interventions. Clinical trial information: NCT01993498 . [Table: see text]
Racial and ethnic disparities in survival among persons with subsequent primary cancer.
Authors: Sung Hyuna , Nisotel Lauren , Sedeta Ephrem Tadele , Islami Farhad , Jemal Ahmedin
Published: June 2023

12093

Background: Racial and ethnic disparities in survival after first primary cancer diagnoses have been well documented. Yet comprehensive data for disparities after subsequent primary cancer (SPC) are lacking despite the growing burden of SPCs. Methods: This study included 230,370 persons diagnosed with one of the 13 common SPCs at ages≥20 years during 2000-2013 in 18 Surveillance, Epidemiology, and End Results registries. Cause-specific proportional hazards models were used to estimate HR (hazard ratio), overall and stratified by SPC types, comparing the risk of cancer or cardiovascular death in Hispanic, non-Hispanic Asian or Pacific Islander (API), or non-Hispanic Black (Black) persons to that in non-Hispanic White (White) persons. HRs were adjusted for sex, first primary cancer type and stage, age and year of SPC diagnosis (base model); and additionally household income, urbanicity, SPC stage, subtype, and treatment receipt (surgery, radiotherapy, chemotherapy) (final model). Results: During 54 months of median follow-up, 109,757 cancer deaths and 18,283 cardiovascular deaths occurred among persons with SPCs. Overall, HRs for cancer death were higher among Black (HR = 1.21, 95% CI = 1.18-1.23) and Hispanic (HR = 1.10, 95% CI = 1.07-1.13) persons compared with White persons, but lower among API persons (HR = 0.93, 95% CI = 0.90-0.96) in the base model. When stratified by SPC types, the increased HRs were evident for 10 of 13 cancers among Black persons with the greatest HR among those with uterine corpus cancer (HR = 1.87, 95%CI = 1.63-2.15) and for 7 of 13 cancers among Hispanic persons with the highest HR among those with melanoma (HR = 1.46, 95%CI = 1.21-1.76). For cardiovascular death, compared with White persons, the overall HR was higher among Black (HR = 1.42, 95% CI = 1.35-1.49) persons but lower among API (HR = 0.75, 95%CI = 0.69-0.81) and Hispanic (HR = 0.90, 95% CI = 0.84-0.96) persons. The risk of cardiovascular death was higher for 11 of 13 cancers among Black persons with the greatest HR among those with pancreatic (HR = 1.80, 95%CI = 1.17-2.75), thyroid (HR = 1.70, 95%CI = 1.12-2.57), and kidney (HR = 1.63, 95%CI = 1.38-1.93) cancers. Additional adjustments in the final model reduced the elevated HRs substantially especially for cancer death among Black or Hispanic persons, although the associations remained statistically significant for most cancers. Conclusions: Among persons with SPCs, Black persons had a higher risk of death from both cancer and cardiovascular disease, whereas Hispanic persons had a higher risk of death from cancer. Adjusting for differences in potentially modifiable factors attenuated the associations substantially, highlighting opportunities for interventions toward health equities among cancer survivors.
Sexual dysfunction in patients with cancer: Results from the CLARIFY project.
Authors: Ospina Serrano Aylen Vanessa , Maximiano Constanza , Cantos Sanchez de Ibarguren Blanca , Torrente Maria , Mendez Miriam , Sanchez Juan Cristobal , Calvo Virginia , Lorduy Ana Collazo , Blanco Mariola , Nuñez García Beatriz , Triana Ivan , Parejo Consuelo , Martinez Paula , Florez Narjust , Provencio-Pulla Mariano
Published: June 2023

12094

Background: Survivors patients with cancer may suffer long-term consequences related to antineoplastic treatments and tumor itself, leading to deterioration of quality of life and resulting in disturbances including sexual dysfunction (SD). We aimed to identify and characterize SD in a cohort of Spanish patients. Methods: Analytical observational study in patients included in the CLARIFY H2020 project at the Hospital Universitario Puerta de Hierro. From October 2020 to May 2022, clinical and demographic variables were collected as well as measures of sexual function using a validated Spanish-language, gender-targeted separately questionnaire. A descriptive domain on frequency of sexual activity during the last four weeks (DFSA) and multiple domains assessing phases of sexual response (DESR), according to DSM IV and DSM V parameters including desire, arousal, lubrication, orgasm, satisfaction with sexual performance, global sexual satisfaction, anticipatory anxiety and sexual initiative were evaluated. Descriptive, trend associations and logistic regression analyses were performed. Results: 383 patients were included, cancer type distribution was breast cancer 68.14% (261), lung cancer 26.37% (101) and lymphomas 5.50% (21). The average age was 56.5 years (range 33-88). 19.58% (75) of patients were men and 80.42% (308) woman. 69% of men and 31% of women reported they were sexually active. The absolute frequency of Global sexual dissatisfaction (GSD) was 76% in women and 24% in men, according to neoplasia; GSD was 36% in patients with early breast cancer, 14% in men with lymphoma, and 9% in men with lung cancer. Women with metastatic breast cancer presented the highest tendency to have severe disorders of DESR. In multinomial logistic regression, significant associations were found in women with metastatic breast cancer and severe disorders of: arousal (p 0.000), lubrication (p 0.002) orgasm (p 0.000), as well as dissatisfaction with sexual performance (p 0.000) and global sexual dissatisfaction (p 0.000). On the other hand, in women with lung cancer, severe arousal disorder (p 0.016) and global sexual dissatisfaction (p 0.044) were observed. Table. Conclusions: In our study, cancer survivors have high prevalence of SD related with oncological treatment and clinical characteristics of malignancy, being women the most affected population. Efforts should be made to support SD during follow-up to improve the quality of life of this growing oncologic population. [Table: see text]
Associations of employment disruptions and financial hardship among individuals diagnosed with cancer in the US.
Authors: Halpern Michael T. , De Moor Janet , Han Xuesong , Zhao Jingxuan , Zheng Zhiyuan , Yabroff Robin
Published: June 2023

12097

Background: Financial hardship is experienced by approximately half of working-age individuals diagnosed with cancer. Many working individuals diagnosed with cancer also experience disruptions with their employment. This study examines whether employment disruptions are associated with financial hardship among individuals diagnosed with cancer in the US. Methods: We utilized data from the 2016/2017 Medical Expenditure Panel Survey (MEPS) Experiences with Cancer self-administered questionnaires and identified individuals diagnosed with cancer at age >18 who worked for pay at the time of or following their cancer diagnosis. Employment disruption was defined as taking extended paid time off work; switching to a part time or less demanding job or to a flexible work schedule; and/or retiring early due to cancer, cancer treatment, or late effects. Financial hardship was defined in 3 domains: material (borrowing money, financial sacrifices, or being unable to cover medical costs); psychological (worrying about medical bills, financial stability, keeping job/income, or future earnings); and behavioral (delaying/forgoing medical care because of cost). Multivariable logistic regression analyses adjusting for the MEPS survey design were used to determine associations of employment disruption due to cancer with any financial hardship and with financial hardship intensity while controlling for patient demographic, health insurance, and clinical characteristics. Results: Among 732 individuals with a cancer history, 47.4% experienced employment disruptions and 55.9% experienced any financial hardship. Financial hardship was significantly more common among cancer survivors with employment disruptions than without disruptions (68.7% vs. 44.5%; p-value of difference < 0.0001). Findings were consistent across multiple hardship measures/domains and across years since last cancer treatment. In multivariable logistic regression analyses, cancer survivors with employment disruptions were significantly more likely to have greater (OR = 2.8; 95% CI 2.0, 3.9) financial hardship intensity. Individuals of race/ethnicity other than non-Hispanic White; who had Medicare (vs. private) insurance and were age < 65 years old at diagnosis; or had breast, colon, or prostate cancer (vs. melanoma reference group) were also more likely to experience financial hardship. Older individuals and those who were married were less likely to experience financial hardship. Conclusions: Employment disruptions are common and significantly associated with multiple types of financial hardship among cancer survivors. Employer workplace accommodation and other policies to minimize disruptions among individuals diagnosed with cancer may reduce financial hardship in this vulnerable population.
Out-of-pocket costs burden for cancer treatment toxicities and symptoms management in Italy: A prospective, multicenter pilot study.
Authors: Raffaele Giusti , Filetti Marco , Lombardi Pasquale , Gentile Gabriella , Toccaceli Paolo , Fumi Guglielmo , Vacca Denise , Colpani Emilia , Ravoni Giulio , Daniele Gennaro , Porzio Giampiero
Published: June 2023

12105

Background: Financial Toxicity (FT) refers to the financial burden and stress experienced by cancer patients as a result of the high costs associated with their treatment and care. This burden can significantly impact patients and families, affecting not only their financial well-being but also their physical and mental health. With the increasing cost of cancer care, FT has become a primary concern for those affected by the disease. Although there have been plenty of studies on the cost of cancer drugs and policy issues relating to curbing these increasing costs, studies on addressing FT in individual patients for drug-related toxicity and symptom management are still lacking. Methods: From January to October 2022, we conducted a cross-sectional, descriptive study to identify patient-administered drugs used to manage cancer treatment toxicities or cancer-associated symptoms. We recognize six common symptoms (anorexia/cachexia, fatigue, nausea and vomiting, pain, constipation, and diarrhea). All social and demographic data, including information on gender, age, performance status, education, and income, have been gathered and recorded. We collected information about the type of cancer disease and active treatment (on/off). Symptom assessment and financial distress were analyzed by administering the PERSONS and COST questionnaires, respectively, at the time of enrollment. Results: A total of 211 patients were enrolled and completed the questionnaires. 28/211 patients (13%) do not take any medications to control symptoms. Of the remaining 183 taking at least one prescription for managing these symptoms, 90% (165) pay for at least part of these drugs. Most frequently, patients assumed medicines for controlling pain (45%) and constipation (28%). Unlike all the other drug categories, these medicines correlate with financial distress (p > 0.0001 and p > 0.001). None of the following variables (age, type of tumor, and work situation) significantly interacted with COST and PERSONS at the univariate analyses. In contrast, a lower level of education significantly associates with the worst COST and PERSONS scores (p > 0.0001). As expected, patients in palliative home care have a higher mean score for symptom burden than those without home care and, surprisingly, a higher financial distress score. Conclusions: Our results identify cancer pain and constipation as the most incident and challenging problems associated with cancer diagnosis and treatment. Moreover, they ultimately lead to a higher financial hardship due to patient self-prescribing and out-of-pocket purchases of over-the-counter drugs to control them. In our population, a lower education level is an independent risk factor for developing financial distress.
Quality of pain management in patients with cancer in the outpatient setting.
Authors: Adhikari Biplov , Shrestha Nistha , Maskey Smriti , Bhatt Vijaya Raj
Published: June 2023

12106

Background: Pain represents a common health issue among patients with cancer. Uncontrolled pain significantly impairs the quality of life, resulting in increased healthcare utilization and costs. We examined the patterns of pain medication prescriptions among patients with cancer pain in the outpatient setting. Methods: We used the National Ambulatory Medical Care Survey (NAMCS), an annually administered survey designed to collect data regarding the use of ambulatory medical services from office-based physicians in the United States. We analyzed NAMCS data from 2005 to 2019 for all types of cancers visits. The primary outcome was prescription of pain medications among patients with cancer pain. We performed multivariate logistic regression to identify factors associated with opioid and non-opioid prescription among patients with cancer pain. Results: We captured a total of 520.8 million outpatient visits from 2005-2019. Breast cancer (18.7%) followed by cancer of the male genital tract (11.0%) represented the highest proportion of patient visits. 4.8% of cancer patients reported pain. Majority (60%) complaining of pain did not receive any pain medications. 14.9% received opioids and 25.1% received nonsteroidal anti-inflammatory drugs, acetaminophen, or adjuvant pain medications. The odds of receiving opioids were 3.4 times higher among 45-65 years vs patients over 75 years. African-Americans had 84% higher odds of receiving opioid prescription compared to white patients. The odds of receiving opioids were 61% lower for privately insured vs patients on Medicare. Patients visiting oncologic care had 2.1 times higher odds of receiving opioids compared to primary care (Table). Conclusions: This is one of the largest drug utilization studies among patients with cancer in outpatient setting, covering half a billion patient visits. A significant proportion of outpatients with cancer who reported pain did not receive a prescription for analgesics suggesting a possibility of undertreatment of pain. Within the limitation of this dataset, undertreatment of pain in outpatients with cancer remains a major unmet patient need. [Table: see text]
Patient-reported hope, prognostic understanding, quality of life, symptom burden, coping mechanisms, and financial wellbeing in early phase clinical trial participants.
Authors: Lundquist Debra , Durbin Sienna , Pelletier Andrea , Petrillo Laura A , Bame Viola , Turbini Victoria , Heldreth Hope , Lynch Kaitlyn , Silva Jenipher , McIntyre Casandra , Juric Dejan , Ferrell Betty R. , Jimenez Rachel , Nipp Ryan David
Published: June 2023

12109

Background: Early phase clinical trials (EP-CTs) investigate novel treatment options in oncology, with recent advances in personalized therapy leading to improved outcomes and offering hope to patients with cancer. However, little research has sought to understand hope in EP-CT participants, thus we sought to study associations of patient-reported hope with prognostic understanding, quality of life (QOL), symptom burden, coping mechanisms, and financial wellbeing in EP-CT participants. Methods: We prospectively enrolled consecutive adults with cancer participating in EP-CTs at Massachusetts General Hospital from 04/2021-01/2023. Participants completed baseline surveys prior to treatment initiation that assessed hope (Herth Hope Index [HHI], higher scores indicate greater hope), prognostic awareness (Prognosis and Treatment Perceptions Questionnaire [PTPQ], QOL (Functional Assessment of Cancer Therapy-General), symptom burden (physical: Edmonton Symptom Assessment System [ESAS]; psychological: Patient Health Questionaire-4 [PHQ4]), coping mechanisms (Brief COPE), and financial wellbeing (Comprehensive Score for Financial Toxicity [COST]). We used descriptive statistics and regression models to explore associations of hope with patient characteristics as well as patient-reported prognostic awareness, QOL, symptom burden, coping, and financial wellbeing. Results: Of 221 eligible patients, we enrolled 204 (enrollment rate 92.3%, median age = 63.4 years [range 54.8-70.5]; 56.9% female, and 94.0% metastatic cancer). Most common cancer types were gastrointestinal (34.8%), breast (19.6%), and head and neck (10.3%). Patients had a mean HHI score of 27.2 (range 12.0-36.0), with 27.1% reporting their cancer is curable (mean hope scores were higher for those reporting curable vs incurable on the PTPQ: 28.8 vs 26.7, p = 0.016). Higher hope scores were associated with better QOL (B = 0.21, p < 0.001), lower symptom burden (ESAS-physical: B = -0.10, p < 0.001; PHQ4-depression: B = -2.10 p = < 0.001; PHQ4-anxiety: B = -0.99, p < 0.001), more adaptive coping strategies (self-blame [B = -1.34, p < 0.001]; acceptance [B = 1.30, p < 0.001], denial [B = -1.31, p < 0.001], support [B = 1.03, p < 0.001], active [B = 0.97. p < 0.001], disengage [B = -2.69, p < 0.001], religion [B = 0.63, p < 0.001]), and greater financial wellbeing (B = 0.10, p = 0.013). Conclusions: In this prospective cohort study, we found novel associations of higher hope scores with prognostic understanding, better QOL, lower symptom burden, more adaptive coping mechanisms, and greater financial wellbeing. Future studies should measure patient-reported hope and explore its role as a potential moderator of other outcomes in EP-CT participants.
Rose geranium in sesame oil nasal spray to improve symptoms of nasal vestibulitis: A phase III double blinded randomized controlled trial.
Authors: Cathcart-Rake Elizabeth Jane , Novotny Paul J. , Smith Deanne R. , Lewis-Peters Susan E. , Giridhar Karthik , Steinert Kimberly O. , Dauer Darcie , O'Connor Amanda K. , Thome Stephan , Register Terra A. , Erickson Marsha K. , Friday Bret Edward Buckley , Loprinzi Charles L.
Published: June 2023

12114

Background: A retrospective study suggested a potential benefit from rose geranium in sesame oil nasal spray for alleviating nasal vestibulitis symptoms in patients (pts) undergoing chemotherapy. Methods: Pts undergoing active chemotherapy who reported moderate or worse nasal symptoms were randomized 1:1 to receive a rose geranium in sesame oil nasal spray (RG) or an isotonic saline nasal spray (IS), administered twice daily for two weeks. Consenting pts completed nasal symptom questionnaires at baseline and then weekly while on treatment. The number and percentage of pts experiencing improvements in their nasal symptoms 2 weeks after initiating the nasal spray, defined as symptoms moderately (2) or very much (3) better on a 7-point global impression of change score (ranging from scores of -3: very much worse, to 3: very much better), was estimated within and then between each randomized arm, using Fisher’s exact test (5% significance level). The estimated odds ratio was determined (95% confidence interval). After 2 weeks, pts initially randomized to IS were allowed to cross-over to RG and completed weekly surveys. Results: 106 pts consented to this study; 43 pts in the RG arm and 41 in the IS arm were evaluable for the primary endpoint. Pts had a mean age of 57.8 (SD 13.9). Demographic characteristics and baseline nasal symptoms were similar between arms. The most prominent baseline nasal symptoms were dryness (36%) and bleeding (35%). Of the 43 evaluable pts who received RG, 67.4% reported improved nasal symptoms, compared with 36.6% of the 41 pts who received IS (p=0.009; Table). On the global impression of change score, pts who received RG had a mean score of 1.93 (SD 1.16), compared to a mean score of 0.98 (SD 1.41) among pts who received IS. Adjusting for potential confounding factors, pts who received RG had a 4.56 odds of responding to the nasal spray, compared with those who received IS (p=0.005). There were no significant differences between pt responses based upon type of nasal symptoms, age, allergies, or gender. Adverse events were sparse and did not differ between arms. 34 pts crossed over to RG after week 2. Among the 29 pts who completed final surveys, 37% reported a response on IS, 79% reported a response on RG. Conclusions: Rose geranium in sesame oil nasal spray significantly improves nasal vestibulitis symptoms among patients undergoing chemotherapy. Clinical trial information: NCT04620369 . [Table: see text]
Patient-controlled subcutaneous analgesia with hydromorphone versus oral oxycodone for opioid titration of cancer pain: A prospective multicenter randomized trial.
Authors: Xiao Xiaoguang , Chu Qian , Chen Yuan
Published: June 2023

12124

Background: Studies have shown that oral oxycodone sustained-release (SR) tablets can be used for opioid titration. The European Society for Medical Oncology (ESMO) guidelines for adult cancer pain recommend opioid titration through the parenteral route, usually the intravenous or subcutaneous route. Patient-controlled subcutaneous analgesia (PCSA) with hydromorphone needs further evaluation for opioid titration. This prospective multicenter study was designed to compare the efficacy and safety of hydromorphone PCSA with oral oxycodone SR tablets for opioid titration of cancer pain. Methods: Eligible patients with cancer pain were randomly assigned in a 1:1 ratio to the PCSA group or the oxycontin group for dose titration. Different titration methods were given in both groups depending on whether the patient had an opioid tolerance. The primary endpoint of this study was time to successful titration (TST). Results: A total of 256 patients completed this study. The PCSA group had a significantly lower TST compared with the oxycontin group (median [95% confidence interval (CI)], 5.5 [95%CI: 2.5-11.5] hours vs. 16.0 [95%CI: 11.5-22.5] hours; p< 0.001). PCSA reduced the frequency of breakthrough pain (Btp), especially in patients with opioid tolerance. The number of Btp was 121±28 times and 186±31 times in the PCSA and oxycontin groups, respectively ( p< 0.001). The 12-hour numeric rating scale (NRS) score was significantly lower in the PCSA group than that in the oxycontin group (median [95%CI], 2.5 [95%CI: 1.4-2.9] vs. 4.4[95%CI: 3.2-5.8]) ( p< 0.001). Similar equivalent morphine consumption and significantly improved quality of life were observed in the two groups. No between-group difference in the incidence of opioid-related adverse effects was observed. Conclusions: Compared with oral oxycodone SR tablet, the use of PCSA with hydromorphone achieved faster pain relief and a shorter titration duration for patients with cancer pain without increasing adverse events. Clinical trial information: ChiCTR2000037845 .
A phase III, double-blind, non-inferiority, randomized controlled trial of antiemetic prophylaxis for highly emetogenic chemotherapy without dexamethasone: CINV POD study.
Authors: Radhakrishnan Venkatraman , Venkatakrishnan Kritthivasan , Perumal Kalaiyarasi Jayachandran , Selvarajan Gangothri , Mahaboobasha Nizamudin , Vijaykumar Victor Paulson , Anbazhagan Malarvizhi , Sivanandam Deyva Manohari , Rajaraman Swaminathan
Published: June 2023

12127

Background: Chemotherapy-induced nausea and vomiting (CINV) is a common side effect of highly emetogenic chemotherapy (HEC). Current guidelines recommend the use of dexamethasone (DEX) for prophylaxis, but the effectiveness and safety of a DEX-free regimen for CINV prophylaxis in HEC is not known. Methods: This was an investigator-initiated, double-blind, phase 3 RCT designed to show the non-inferiority of a DEX-free regimen (olanzapine, palonosetron, and fosaprepitant; OPF) compared to the NCCN recommended DEX-containing regimen (olanzapine, palonosetron, and dexamethasone; OPD). Chemotherapy-naive patients aged 18-80 years receiving single-day HEC were randomized 1:1 to receive either the OPD regimen (olanzapine 5 mg once a day on days 1-4, palonosetron 0.25 mg on day 1, and DEX 12 mg on day 1) or the OPF regimen (olanzapine and palonosetron as above, and fosaprepitant 150 mg on day 1). The primary endpoint was to compare complete response (CR) rates for vomiting (no vomiting and no rescue medication) during the overall phase (start of chemotherapy to 120 h). The secondary endpoints were CR for nausea (ESAS), toxicities (CTCAE), and patient reported outcome measures (PROM) using MDASI. Assuming CR for vomiting for the overall phase of 77% (power = 90%, 2-sided alpha = 5%, and non-inferiority margin [NI] = 15%), 175 patients in each arm were required (including 5% dropout). Results: Between May 2022-Dec 2022, 350 patients were randomized and 346 received the study interventions (OPD arm n = 174 and OPF arm n = 172). The most common chemotherapy used was adriamycin/cyclophosphamide (66%) followed by cisplatin (27%). CR rates for vomiting for the overall phase were 48.8% in the OPD arm and 79.6% in the OPF arm (P < 0.001), with an absolute difference of -30.8% and 2-sided 95% CI = (-40.31, -21.24) which was within the pre-defined NI margin of 15% and also showed superiority. The DEX-free arm also had significantly higher CR rates for nausea and total control (vomiting and nausea combined) (Table). There were no significant differences in any grade CTCAE toxicities. PROM for fatigue (P = 0.009) and drowsiness (P = 0.002) were more in the OPF arm in the acute phase, and insomnia (P < 0.001) in the OPD arm in the delayed phase. Conclusions: This study shows that a DEX-free OPF regimen is superior to the DEX-based OPD regimen and should be considered a standard option for CINV prophylaxis for HEC. Clinical trial information: CTRI/2022/03/040906 . [Table: see text]
Palliative care in hematopoietic stem cell transplant recipients and impact on survival: A nationwide analysis.
Authors: Premnath Naveen , Khan Adeel , Pandey Mohak , Pandey Urvashi , Hoff Fieke W , Chung Stephen , Ramakrishnan Geethakumari Praveen , Awan Farrukh Tauseef , Anderson, Jr Larry D. , Kaur Gurbakhash , Afrough Aimaz , Wolfe Heather , Yilmaz Elif , Collins Robert , Terauchi Stephanie , Paulk Elizabeth , Sweetenham John W. , Madanat Yazan F
Published: June 2023

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Background: Palliative care benefits have been widely studied in solid tumors with early palliative care demonstrating prolonged survival in several malignancies including lung and esophageal cancer. There are limited data and guidelines for use of palliative care in hematopoietic stem cell transplants (HSCT). Methods: We used the National cancer database (NCDB) to identify HSCT recipients between 2004 to 2017 and retrospectively examined the outcomes based on receipt of palliative care. Chi-square and Wilcoxon tests were used to compare categorical and continuous variables respectively. Kaplan Meier analysis and a Cox multivariable proportional hazards model were used for survival analysis using R software. The NCDB is available as de-identified data. Hence, this study was exempt from a full IRB review. Results: We identified 17,464 eligible patients with hematologic malignancies who underwent HSCT during 2004-2017. The table below shows differences in baseline characteristics in patients who received palliative care vs no palliative care and shows an improved median survival in those receiving vs those not receiving (43.5 vs 31.6 months) (p = 0.0003). Patients with median household income in the lowest quartile as per 2016 survey data were taken as low-income group. A multivariable cox regression analysis that adjusted for age, sex, Charlson-Deyo Comorbidity Index, insurance status, income and Hispanic ethnicity found that integration of palliative care was associated with improved survival outcomes (HR 0.85, CI 0.77- 0.93, p = 0.0002). Conclusions: To our knowledge, this is the largest study demonstrating improved outcomes in HSCT recipients when palliative care was incorporated despite there beingmore economically challenged patients in the group that received palliative care. Although these data are retrospective and correlational, it underscores how palliative care should be incorporated as part of national society guidelines for HSCT recipients. [Table: see text]