bluuebunny/crossref_metadata_2025 huggingface dataset:
Development of a remote Mediterranean Diet intervention during chemotherapy treatment: A qualitative analysis.
Authors: Kleckner Amber , Reschke Jennifer E , Cherubin Lisadine , Youngblood Shari , Peppone Luke Joseph
Published: June 2022

e24033

Background: The Mediterranean Diet (MedDiet) has emerged as an effective health-promoting dietary pattern. It is high in fruit, vegetables, whole grains, fiber, antioxidants, and anti-inflammatory compounds. A cancer diagnosis is often seen as a “window of opportunity” for behavior change, yet there are few structured nutritional programs available for patients undergoing active treatment. Herein, we developed a remote MedDiet intervention and identified barriers and facilitators to adherence. Methods: This was a qualitative analysis of the intervention arm of a clinical trial (NCT04534738). Participants had at least 6 weeks of chemotherapy scheduled. The MedDiet intervention was 8 weeks and included home food delivery (frozen meals and fresh ingredients weekly for the first 4 weeks), education, goal-setting, a cookbook, and weekly phone calls with a nutritionist. MedDiet adherence was measured using the MedDiet Adherence questionnaire at baseline, 4 weeks, and 8 weeks; change was assessed using paired t-tests between baseline and 4 and 8 weeks. After the study, participants underwent a semi-structured interview to provide feedback on the intervention. Interviews were transcribed and emergent coding was used to identify themes. Results: Patients (n = 23) were 52.5±13.6 years old, 2 were male, 83% were White, and 87% had breast cancer. MedDiet adherence was 4.0±2.7 at baseline. It increased 2.1±3.2 points from baseline to 4 weeks and 2.5±3.0 from baseline to 8 weeks (both p < 0.001). Interviews were conducted with 21 patients (example quotes in Table). Although most participants (n = 15, 71%) did not seek nutritional information at the time of their diagnosis, most (n = 19, 90%) were highly engaged with the program. In response to an open-ended question, many (n = 11) expressed a sense of empowerment. Facilitators to adherence included structure, accountability, food provision, palatability, and easy procurement of ingredients. Barriers included chemotherapy-induced taste changes and mouth sores, cooking for family members’ preferences, others preparing food for the patient, and higher priority areas for mental energy expenditure. The majority (n = 13, 62%) preferred a program during vs. after cancer treatment. All (21/21) indicated they would continue to follow at least some aspects of the diet. Conclusions: A remote MedDiet intervention was effective and well received by patients undergoing chemotherapy. Future research should investigate how a MedDiet intervention affects clinical outcomes and symptom burden. Clinical trial information: NCT04534738. [Table: see text]
Smoking cessation after cancer diagnosis: Relationships matter.
Authors: Neumann Melissa Francoise , Murphy Neal J , Seetharamu Nagashree
Published: June 2022

e24039

Background: Continued smoking after a cancer diagnosis leads to worse morbidity and mortality. Unfortunately, smoking prevalence remains high amongst cancer patients and survivors. Few studies have been conducted to evaluate and target patients’ social networks that may contribute to a patient continuing to smoke. We developed a questionnaire intended to assess patients’ smoking status, motivation to quit, patient/family dynamics, and interest in enrolling in a smoking cessation program that includes the patient and the person closest to them in their social network that may be contributing to their continued smoking. Methods: We designed a three-page questionnaire to gain more information about a patient’s past and current smoking history, level of nicotine dependence, assessment of their motivation to quit smoking, their social network and family/friends who may be smoking, and willingness of the patient and close family to quit. Inclusion criteria included patients who have been diagnosed with any solid tumor malignancy and had a history of smoking or recently quit. Non-smokers were excluded. IRB approval was obtained and questionnaires were distributed to patients when checking in at the front desk of the Monter Cancer Center. 32 questionnaires were collected from July 2021 - January 2022. Results: Of the questionnaires completed, 59% quit smoking after their cancer diagnosis, 34% tried and were unable, and 7% did not try or declined to answer. Of the 59% who quit, 52% were married, compared to 45% of the 34% who tried and were unable to quit. The odds of quitting among people who were married was 1.56 (95% CI 0.36 - 6.69; p-value 0.55) times the odds of quitting among people who were not married. In the quit group, 53% lived with a smoker at some point compared with 75% of those in the quit but unable to group. The odds of quitting among people who lived with a smoker was 0.42 (95% CI 0.08 - 2.07; p-value 0.28) times the odds of quitting among people who did not live with a smoker. Five social network members quit after their relatives’ cancer diagnosis. No patients were currently enrolled in a tobacco cessation program. Two people answered they would be interested in being enrolled in a tobacco cessation program with a close family member that also smokes. Conclusions: Our study highlights high rates of continued smoking amongst cancer patients. Being diagnosed with cancer can serve as a teachable moment and motivate patients to quit smoking. Social network plays an important role in tobacco cessation. Our study showed that the odds of quitting was lower in patients who lived with smokers than those who did not, though not statistically significant likely due to small sample size. None of the active smokers were enrolled in a smoking cessation program highlighting the imminent need for innovative smoking cessation platforms that are engaging and effective in improving quit rates amongst cancer patients.
Cancer survivorship in gulf countries: A systematic review.
Authors: Hameed Maha , Ashraf Aqsa , Faisal Muhammad Salman
Published: June 2022

e24046

Background: Cancer survivors have been increasing worldwide due to advancements in early cancer detection, chemo-hormonal therapy, and improved supportive care with an estimated four-to-five-fold increase in cancer burden in Gulf countries by the year 2040. Cancer survivorship deals with the host of challenges that cancer leaves in its wake. We seek to explore the experience of Gulf countries' cancer survivors and identify the gaps that need to be addressed. Methods: A systematic review of current evidence regarding cancer survivorship in the 6 Gulf countries (inclusive of Bahrain, Kuwait, Oman, Qatar, Saudi Arabia, and the United Arab Emirates) was conducted according to the PRISMA 2020 checklist, without restricting to a starting date. We searched five major online databases: Embase, Cochrane, PubMed, SciELO, and Web of Science. Twenty-two articles were reviewed for the inclusion of predefined domains of cancer survivorship (Nekhlyudov et al, JNCI 2019). Results: Most of the studies included were published in Saudi Arabia (63.6%), followed by UAE (13.6%), Oman (9.1%), Bahrain (4.5%), Kuwait (4.5%), and Qatar (4.5%). Data within the included studies encompassed 9 domains of survivorship, of which clinical structure was reported most consistently (95.5%), followed by surveillance and management of physical and psychosocial effects (77.3% and 68.2% respectively). The most frequently reported domain, clinical structure, refers to the type of healthcare delivery environment offered, patient education, availability of necessary specialty care and subsequent healthcare professionals, access to care, the functionality of available healthcare information systems (e.g., electronic medical records and telehealth) and whether opportunities for research participation was offered to patients. Comparatively, the three domains health promotion (27%), patient experience (27%), and surveillance and management of chronic medical conditions (13%) were reported least frequently. Conclusions: Cancer survivorship in Gulf countries is currently in its infancy, evidenced by a paucity of literature on the topic. This systematic review assesses domains explored by available studies, finding a significant focus on clinical structure. Gaps in literature particularly within the surveillance and management of chronic medical conditions in cancer survivor patients need to be addressed in future research.[Table: see text]
Gender and weight change, skeletal muscle index(SMI) change, and survival in advanced non-small cell lung cancer(NSCLC) patients(pts.) receiving platinum chemotherapy.
Authors: Fidler Mary Jo J. , Shah Palmi , Moudgalya Hita , Batus Marta , Borgia Jeffrey Allen , Bonomi Philip D.
Published: June 2022

e24080

Background: Significantly longer OS has been reported in advanced NSCLC pts. who gained weight or maintained (skeletal muscle mass) SMI during treatment with platinum containing chemotherapy. None of these studies evaluated the relationship between OS and both weight and SMI. Sex specific distributions are described for cachexia and muscle wasting. Methods: The objective of this retrospective study was to evaluate the relationships between OS and both weight gain and SMI maintenance during front line chemotherapy in advanced NSCLC pts. Weight and SMI measurements(cm2/m2) were done at baseline and at 6, 12, & 24 weeks. OS was estimated using the Kaplan-Meier method. The associations of weight and SMI with overall survival were assessed using Kaplan-Meier, log-rank test and proportional hazards regression. Results with p < 0.05 were reported as significant. Results: Characteristics for the 88 patients were: median age – 64 years, women – 57%, caucasian – 68%, black – 25%, and adenocarcinoma histology – 63%. Weight gain (i.e., > 0%) and > 5% weight gain were observed in 50% and 11.3% of the patients, respectively. For all 88 patients the hazard ratio(HR) for OS in patients with > 0% vs < 0% weight change was 0.544 (p = 0.0164), and the HR for OS for weight > 5% vs < 5% was 0.469 (p = 0.099). The HR for OS in men for > 0% vs < 0% weight gain was 0.421(p = 0.031), and HR for OS > 5% vs < 5% weight gain was 0.421 (p = 0.031). The same analyses in women showed no significant differences. Increases in SMI > 0% and > 5% SMI were found in 48% and 35% of patients, respectively. Maintenance of SMI defined as > - 1.3% was observed in 25% of pts. The HR for OS in men with SMI maintenance versus loss was 0.230 (p = 0.031), and the HR for OS in men with SMI increase > 5% vs < 5% was 0.219 (p = 0.0267). Neither SMI gain nor maintenance were significantly related to OS in the entire patient group or in women. Conclusions: In patients treated with first line platinum doublet, as a group there were no significant relationships between weight changes or SMI changes and OS. The observation that either weight gain or SMI maintenance was associated with longer OS in men only is based on data from a small number of patients. However, if larger studies show similar results, these findings could have implications for clinical and translational research in cachexia.
Physical and psychological symptom burden in patients newly diagnosed with solid organ cancers in a tertiary care centre in India.
Authors: Batra Atul , kumar akash , Pramanik Raja , Khurana Sachin , Pushpam Deepam , Bakhshi Sameer , Sharma Atul , Gogia Ajay , Malik Prabhat Singh
Published: June 2022

e24081

Background: Assessment of physical and psychological symptoms using patient-reported outcome (PRO) scales is an often overlooked aspect in oncological practice in resource constrained settings. We assessed the pattern of symptoms at diagnosis in solid organ cancers using an innovative smart device based delivery of the Edmonton Symptom Assessment Scale (ESAS). Methods: We assessed PROs using ESAS at diagnosis in adult patients diagnosed with solid organ cancers at a large tertiary care centre in New Delhi, India from September 2021 to January 2022. The ESAS was delivered to patient's smart phone as a text message that provided a unique link to complete the questionnaire in Hindi or English, as preferred by the patient. Symptom severity was categorized into physical, psychological, and total symptom domains and the scores were further classified as none to mild (0-3) or moderate to severe (4-10). Univariate and Multivariate logistic regression analyses were performed to determine predictive factors. Results: Text message with ESAS completion link was sent to 653 consecutive patients, of whom 509 (77.9%) completed the questionnaire during the study period. The median age was 52 years and 53.2 % were males. The primary cancer site was lung, breast, gastrointestinal, and others in 27.7%, 28.1%, 14.4%, and 29.8%, respectively. Pain (59.1%) and tiredness (57.8%) constituted the maximum physical symptom scores in moderate and severe category. Patients with lung cancer had most physical symptoms categorised in moderate and severe compared with other cancers (P = 0.03), while psychological symptoms were more likely to be moderate to severe females (P = 0.01). In the multivariable logistic regression analysis after adjusting for measured confounders, primary cancer site (lung vs others) and sex (female vs male) were significant predictors for moderate and severe physical and psychological symptoms, respectively. Conclusions: A simple mobile-based ESAS delivery system can help in collecting PRO data to assess symptom burden in patients diagnosed with cancer. The symptom burden assessment can aid in providing personalised symptom-directed measures to improve the quality of life of patients with cancer.
Outcomes of a resilient living program for patients with advanced cancer and their caregivers.
Authors: Pachman Deirdre R. , Chesak Sherry , Cutshall Susanne M , Mandrekar Jayawant , Rummans Teresa A , Clark Matthew M , Lapid Maria I
Published: June 2022

e24087

Background: Patients with advanced cancer and their caregivers experience a substantial amount of distress. Limited research suggests that mindfulness-based interventions may improve quality of life and reduce anxiety. The virtually delivered Resilient Living program consisted of online modules, a print journal, and a total of 4 virtual training sessions focused on techniques for managing stress and building resilience (mindful presence, uplifting emotions, reframing experiences through principles of gratitude, compassion, acceptance, meaning, and forgiveness). The current pilot study was performed to assess the feasibility of the virtual Resilient Living Program for patients with advanced cancer and their caregivers, as well as preliminary effects on anxiety and related outcomes. Methods: Eligible patients included those age ≥18 years with a diagnosis of advanced cancer with expected prognosis > 6 months. Feasibility was defined as consent of at least 25% of eligible patients and their caregivers. Adherence was defined as 75% of the enrolled participants completing at least 3 of the 4 Resilient Living sessions. The primary outcome measure was anxiety as measured by the GAD-7; others included stress (PSS), quality of life (LASA), sleep (ISI), resiliency (Resiliency Scale), and fatigue (PROMIS-Fatigue SF). Results: Seventy-two eligible patients were referred to the study, of these 33 patients enrolled (46% enrollment), 15 also had a caregiver enroll. Thirty participants completed at least 3 virtual sessions (63% adherence). Data was collected at baseline, week 5 (after 2 session), week 9 (after 4 sessions), and week 12 (1 month after completion) for patients and caregivers. There were statistically significant improvements in anxiety at weeks 5, 9 and 12 (i.e., p < 0.05). Other results are outlined in the table. Conclusions: Virtual participation in the Resilient Living Program is feasible and acceptable for patients with advanced cancer and their caregivers. Data from this pilot study suggest that the program may positivity impact anxiety, stress, sleep, quality of life and resiliency. A larger randomized prospective clinical trial is warranted to confirm these preliminary findings. Clinical trial information: NCT04480008. [Table: see text]
Increased risk of venous thrombosis in breast cancer patients receiving chemotherapy treatment after COVID-19.
Authors: Ausheva Tatiana V. , Katelnitskaya Oksana V. , Kit Oleg I. , Frantsiyants Elena M. , Vladimirova Liubov Yu , Zakharchenko Viktoria R. , Kaplieva Irina V. , Shatova Iuliana S. , Ardzha Anna Yu
Published: June 2022

e24106

Background: Immune suppression and coagulopathy development in cancer patients receiving chemotherapy determines a high incidence of complications, including venous thrombosis, and mortality from COVID-19 infection. There are still no explicit data on managing cancer patients when anticancer treatment is resumed after coronavirus disease. According to clinical guidelines for the prevention of venous thromboembolic complications in cancer patients receiving chemotherapy, patients with breast cancer are classified as having a low risk of these complications and do not require prophylactic anticoagulation. The purpose of this study was to assess the parameters of the blood coagulation system and the frequency of venous thrombosis in breast cancer patients with chemotherapy resumption after coronavirus disease. Methods: The study included 30 patients receiving anticancer medical therapy for breast cancer after COVID-19. Anticancer treatment was resumed no earlier than 4 weeks after clinical recovery, absence of SARS-CoV-2 RNAs in nasopharyngeal swabs, infiltrative lung damage according to a chest CT scan, exclusion of venous thrombosis by a lower extremity venous ultrasound. Control group included 20 breast cancer patients without a history of COVID-19. Stage I tumors were registered in 26.6% in the main group vs 15% controls; II - 40% vs 60%; III - 20% vs 15%. Some patients were diagnosed with distant metastases (stage IV- 13.3% vs 10%). Results: Initially, before chemotherapy resumption in the main group, half of the patients had elevated levels of fibrinogen and D-dimer compared with the control group (66.7% vs. 35%, p > 0.05). After a cycle of chemotherapy, a significant difference in the coagulation system parameters was noted (73.3% vs 30%). A lower extremity venous ultrasound after the end of the therapy cycle in the main group showed venous thrombosis in 3 patients (catheter-related n = 2, distal vein thrombosis of the lower extremities n = 1), while no venous thrombotic complications were detected in the control group (10% vs. 0%). Conclusions: Breast cancer patients after coronavirus disease 2019 have hemostasis abnormalities and higher risk of venous thrombosis, and the resumption of anticancer treatment increases the incidence of thrombotic complications. COVID-19 should be considered an additional risk factor of venous thrombosis in cancer patients and requires reconsideration of indications for prophylactic anticoagulation when resuming anticancer treatment for patients with breast cancer.
Prevalence, symptom management, and reporting of cannabis use among invasive cancer patients.
Authors: Brasky Theodore M , Newton Alison M , Conroy Sara , Adib Anita , Adley Neema C , Strassels Scott A , Hays John L. , Cooper Ziva D , Wagener Theodore L , Krok-Schoen Jessica L.
Published: June 2022

e24114

Background: Interest in the use of cannabis-based products, including marijuana (products containing ≥0.3% tetrahydrocannabinol [THC]) and cannabidiol (CBD; containing < 0.3% THC) for cancer symptom management, is increasing. Preliminary studies suggest that marijuana and CBD products are effective in alleviating common cancer- or treatment-related symptoms. Few studies have reported on the magnitude of cannabis use among cancer patients, but data remain limited to states with legalized non-medical (i.e., recreational) use. Further, none have assessed the prevalence of CBD use in cancer patients. The reasons for cannabis-based product use and patient attitudes towards discussing use with their physicians are not well understood. Methods: We report preliminary results from an ongoing anonymous cross-sectional study of cannabis use among patients attending 8 clinics at the Ohio State University Comprehensive Cancer Center. Eligible patients were diagnosed with invasive cancer and treated in the past 12 months. Between July 2021 and January 2022, 771 patients were contacted and 639 (82.9%) agreed to participate. Participants answered a validated, extensive cannabis-focused questionnaire and were remunerated with a gift card. We report here frequencies and prevalence proportions of cannabis-based product use, and cannabis-related behaviors and attitudes on reporting use with cancer providers. Missing values were included in the denominator of prevalence calculations, thereby making estimates conservative. Results: Participants were equally distributed by sex, White (86.4%), and resided within Ohio (90.3%). Among 433 patients who reported age, the median was 47 years (IQR 38-53). The prevalence of current cannabis-based product use was 15.2% (97/639), with overall prevalence of 6.9% for exclusive marijuana use, 1.7% exclusive CBD use, and 5.2% poly-use. Among current users, patients primarily reported inhaling or ingesting cannabis products; fewer reported topical or other applications. The top 5 reported reasons for cannabis use were to treat stress, improve sleep, reduce pain, improve appetite, and to treat depression. Among current users, 66% reported that their cancer care team was aware of their cannabis use, 17.5% reported none of their healthcare providers were aware, and 15.4% reported a medical professional unaffiliated with their cancer care was aware. A large proportion (86.6%) felt comfortable discussing cannabis with their treating physician. Conclusions: Our results indicate current cannabis-based product use for symptom relief among a sizeable minority of adults with cancer in a state where only medicinal marijuana is legalized. Further research is needed to characterize provider perspectives and communication about reported cannabis use among their patients.
Pilot study of a text messaging-integrated and Chatbot-interfaced self-management program for symptom control in GI cancer patients undergoing chemotherapy.
Authors: Wen Kuang-Yi , Gomaa Sameh , Schnoll Max , Zhan Tingting , Bashir Babar , Posey James
Published: June 2022

e24117

Background: Chemotherapy treatments are increasingly provided in the outpatient setting. Patients are expected to monitor and manage a range of diverse and complicated side-effects without readily accessible clinical support. The overall goal of this study is to address the gap in continuity of care during outpatient chemotherapy through the integration of an innovative text messaging system with a Chatbot interface in the real-time monitoring and proactive management of side-effects among gastrointestinal (GI) cancer patients undergoing IV chemotherapy. Methods: Real-time chemotherapy-associated side effects monitoring supportive system (RT-CAMSS) was iteratively developed with patient-centered inputs and evidence-based and theory-guided information to address chemotherapy knowledge, self-care symptom management skills, emotional support, doctor-patient communication, and nutritional and physical activity suggestions. We conducted a single-arm 2-month pilot study, in which GI patients undergoing chemotherapy received two intervention text messages per week and a weekly CTCAE-based symptom assessment delivered through Chatbot interface with tailored feedback. Baseline and post-intervention patient-reported outcome follow-up surveys were collected. Results: 45 eligible patients were approached and 34 consented and enrolled (76% consenting rate). The mean age was 61 (±12). 56% were females and 61.8% were non-Hispanic White. The most frequent cancer type was pancreatic cancer (53%), followed by colon cancer (35%). 27 participants completed the post-intervention follow up (79% retention rate)..Functional wellbeing subscale of the FACT instrument showed significant improvement from baseline to 2 month ( p < 0.05). 27 participants responded to the weekly Chatbot-interfaced symptom assessment at least once (79% feasibility rate). The most frequent reported symptom collected from Chatbot assessment was constipation (50%), followed by weight loss (35%) and fatigue (32%). Post-intervention open-ended satisfaction survey found that participants perceived the intervention easy to use with helpful information. Conclusions: Communication via mobile technologies is highly scalable for improving health services. The study provides preliminary evidence of engagement, acceptability and benefits of RT-CAMSS, which should be evaluated in a controlled clinical trial.
Baseline preferences for digital information engagement in patients with breast cancer by age and status of diagnosis.
Authors: Hu Bonnie , Isakoff Steven J. , Glieberman Eva , O'Rourke Emily , Spring Laura , Moy Beverly , Bardia Aditya , Said Maya , Peppercorn Jeffrey M.
Published: June 2022

e24119

Background: The need for improvement in education and decision-making support for patients with breast cancer is well documented. Digital health applications offer potential to address these needs through widely available smartphone technology. Understanding patients’ baseline preferences for information sources, breast cancer-related topics of interest, and current use of smartphones and how these interests may differ based on demographic and clinical factors can inform the development of a patient-centered digital navigation tool. Methods: As part of a pilot trial of the Outcomes4Me breast cancer navigation app, we conducted a baseline cross-sectional survey of patients presenting for routine breast cancer care at an academic medical center and community-based sites. Eligible patients had invasive breast cancer of any stage and were actively in treatment. Survey-specific questions addressed sources of cancer information and informational needs. Analysis is descriptive with statistical comparisons based on Fisher’s exact test. Results: Ninety out of 107 patients in the pilot trial completed the survey items of interest. The majority of patients were over age 50 (59%) and 35% had stage IV disease. Baseline reported uses for mobile devices included text (67%), email (61%), phone (47%), social media (41%), accessing the internet (18%), and apps (12%). Only 7% of patients noted using mobile apps for navigating disease and treatment options. When asked to rank the importance of cancer information sources, 88% and 42% of patients reported relying heavily on their oncologist and the rest of the care team, respectively. Forty percent of patients relied at least moderately on the internet for health information and 27% on online support groups, with patients < age 50 more likely than those > age 50 to rely on online support groups for health information (41% vs 17%, P = 0.02). The most common educational needs reported were side effects (79%), followed by prognosis (72%), healthy lifestyle (71%), treatment options (70%), general breast cancer news and research (67%), information about their current cancer status (59%), potential clinical trials (44%), and costs of treatment (14%). Patients with metastatic breast expressed greater interest in information about clinical trials compared to those without metastatic disease (64% vs 36%, P = 0.01), and less interest in information about prognosis (54% vs. 81%, P = 0.01). Conclusions: Despite reliance on their oncologist and oncology team for information, patients report multiple unmet educational needs related to their disease and treatment options. While a substantial percentage of patients with breast cancer turn to the internet for information, there is untapped potential to use mobile devices to improve patient education and awareness of treatment options, including clinical trials.
The perception and emotional reaction to genetic test results in cancer patients in an immigrant enriched hospital.
Authors: Bhasin Pooja Gogia , Durana Theresa , Kyaw Nay Yee Wint , Natarajan Vijaya , Best Jacob , Wu Angela , Toom Sudhamshi , Xu Yiqing
Published: June 2022

e24128

Background: Genetic testing detects hereditary cancer syndromes and guides prophylactic surgery, intensive surveillance and family member testing. Despite its surge in use, research studies exploring the cancer patient’s perception and emotional reactions of their genetic test result is sparing. We hypothesized that the patient’s perception may be influenced by their ethnicity, educational level and English speaking status. Methods: Cancer patients who had genetic testing performed in the last 10 years were consented to take a questionnaire survey. The correctness of understanding their genetic test results were studied and compared among various ethnic groups, education levels and first spoken languages. We also evaluated the patient’s emotional reaction towards the result. Results: The data for the first 100 patients were analyzed. The primary tumor sites were breast (n = 71), gynecological (n = 16), gastrointestinal (n = 7), genitourinary (n = 5) and lung (n = 1). Eighteen patients were mutation carriers. The correctness in understanding mutation status was 65.7%, 54.2%, 70% and 45.5% in African American, Asian, Caucasian and Hispanics respectively. The correctness was 60%, 64.5% and 66.67% in patients with education levels of grade school or below, high school, or college or higher respectively. None of the 3 patients who carried a mutation with education level of grade school or lower understood the implications of their mutations. Details of correctness in understanding in patients with and without mutation are provided in the table. The correctness was 61.72% and 63.15% in English speaking vs non-English speaking patients. Patients could recall pre-test counseling in 76% and posttest counseling in 67% of cases. Among mutation carriers, 22.2% had anxiety or stressful feelings about the test result, while in patients with no mutation, 20.7% had anxiety/depression. 67% patients carried out prophylactic surgery as recommended. Conclusions: The correctness of understanding their genetic test results across all ethnic groups, education levels and language was below 70%. Patients with education level below grade school encountered in the immigrant population need more attention. Improvement in communication and patient education is imperative in order to carry out recommendations. Structured emotional support to the patient should always complement genetic counseling and testing.[Table: see text]
The need for a personalized, comprehensive resource within the colorectal cancer community.
Authors: Newcomer Kim , Goodman Andrea , Fathi Negeen , Shoeb Abdullah
Published: June 2022

e24139

Background: Colorectal cancer is the third-most commonly diagnosed cancer and the second-leading cause of cancer death in men and women combined in the United States. In efforts to manage the disease, patients and caregivers turn to a variety of tools and resources for financial assistance, information dissemination, emotional and peer support, and treatment planning, among other critical issues and needs they face. The Colorectal Cancer Alliance (the Alliance) is committed to providing patients and caregivers with a resource solution that encompasses all potential areas of need. Methods: A survey aimed at understanding needs, barriers, and quality improvement opportunity was disseminated via the Alliance's Blue Hope Nation community for two weeks and by email. One hundred sixty-seven colorectal cancer patients and forty caregivers of colorectal cancer patients completed the survey. Results: Patients and caregiver respondents alike report reliance on external tools and resources to manage disease and support information. Of the support methods, patient respondents reported using social media (46.11%); notebooks, journals, and planners (45.41%); online articles (44.91%); the Blue Hope Nation Facebook group (41.32%); cancer discussion boards (35.33%); and spiritual or religious advice (29.94%). Caregiver respondents reported relying on friends and family (57.5%); the Blue Hope Nation Facebook group (47.5%); healthcare websites (47.5%); the Alliance website (42.5%); and spiritual or religious advisors (37.5%). To minimize diagnosis-related stressors, patients reported they look for financial assistance, local peer support and groups, and mental health help. To provide more efficient care and limit stress, the community suggested the need for financial help, communication and support from other patients and caregivers, and informational resources. Conclusions: These survey results are consistent with other published learnings about patient and caregiver reliance on support tools and highlights the myriad resources that patients and caregivers currently use for managing colorectal cancer. The saturation of the market has compelled the Colorectal Cancer Alliance to create a one-stop-shop, personalized resource with tools to organize and effortlessly share customized information treatment plans, and other support mechanisms. Such patient and caregiver-directed resources may enable a better care experience and potentially lead to better physical and mental health outcomes for patients and their caregivers.
Decision making support for cancer patient's treatment strategy during the COVID-19 pandemic in Japan.
Authors: Yoshida Shiori , Sato Fumiko , Sasaki Konosuke , Sasaki Rie
Published: June 2022

e24141

Background: During the COVID-19 pandemic, cancer patients became reluctant to come to the hospital, receive cancer treatment, and were willing to interrupt or postpone treatment due to concerns about infection. The purpose of this study was to discuss effective treatment strategy decision making support for cancer patients during the COVID-19 pandemic. Methods: An online survey was conducted on decision making support among nurses who worked at a cancer care hospital in Japan from May to July 2021. Results: Forty-nine facilities were asked to participate in the survey, and replies were received from 728 respondents; 185 (26.8%) were nurses engaged in the decision making. The most common treatment choice was postponement in 132 patients (73.3%). Nurses who “provided information on measures to prevent COVID-19 infection” were more likely to recognize that “the patient was satisfied with the treatment” (p < 0.05). Nurses who “listened to the patient's thoughts” were less likely to perceive that the patient was “not convinced and continued with the previous treatment” (p < 0.05). Nurses who “listened to the patient's intentions and thoughts after the decision was made,” “followed up on the patient's symptoms and changes in perceptions by telephone,” “followed up on the patient's symptoms and changes in perceptions by videophone”, and “assured the patient that they could take immediate action if symptoms worsened with the physician's permission” more often recognized that the patient “accepted the treatment recommended by the physician although they were not convinced” (p < 0.05). Conclusions: Effective treatment strategy decision making support for cancer patients during the COVID-19 pandemic includes lifestyle guidance for infection prevention, listening to identify the reasons behind patients’ choices, and telenursing for follow-up decision.
Psychological symptoms and quality of life in Chinese early-stage breast cancer patients throughout chemotherapy.
Authors: Lan Bo , Lv Dan , Yang Min , Sun Xiaoying , Zhang Li , Ma Fei
Published: June 2022

e24145

Background: Breast cancer survivors with psychological problems have lower quality of life (QOL) and higher mortality than those without. It is important to monitor and manage their psychological status. The aim of this study was to examine the incidence and dynamic changes of anxiety/depression during postoperative adjuvant chemotherapy in Chinese breast cancer patients and to clarify the factors associated with anxiety/depression, the importance of family support, and the impact of anxiety/depression on QOL. Methods: In a prospective observational single-centre cohort study with early-stage breast cancer patients (n = 290), d epression and anxiety severity, QOL and social support were measured before chemotherapy, after 2 cycles of chemotherapy, and after the entire course of chemotherapy using the Hospital Anxiety and Depression Scale (HADS), Functional Assessment of Cancer Therapy-Breast Cancer (FACT-B) and Chinese version of the Social Support Rating Scale (SSRS), respectively. Canonical correlations were applied to identify correlates between anxiety/depression and demographic and clinical variables. Paired t tests were used to analyse dynamic changes in QOL. Relationships between anxiety/depression and QOL were analysed using two-way repeated measures analysis of covariance (RMANCOVA). Results: Throughout the entire course of chemotherapy, the incidences of anxiety and depression were 35.2% and 44.1%, respectively. 31.4% of the patients had an increased risk for an anxiety disorder before chemotherapy, which decreased to 29.0% after 2 cycles of chemotherapy and slightly increased to 29.3% after completion of chemotherapy. 20.0% of patients had an increased risk of depression before chemotherapy, which shifted to 25.2% and 24.8% after 2 cycles and the entire course of chemotherapy, respectively. Through multivariable analysis, age (p = 0.042), surgical method (p = 0.009), social support (p = 0.001) and breast cancer family history (p = 0.045) were significantly associated with depression. No variables were significantly associated with anxiety. Patients with higher HADS depression/anxiety scores had lower FACT-B scores during chemotherapy (p < 0.001). Conclusions: We observed dynamic changes in depression, anxiety and QOL throughout adjuvant chemotherapy and the associated factors of depression and anxiety. These findings provide guidance for psychological monitoring and support during postoperative chemotherapy of breast cancer patients. Clinical trial information: NCT05055375. [Table: see text]
Erdafitinib in pediatric patients with advanced solid tumors with fibroblast growth factor receptor (FGFR) gene alterations: RAGNAR study pediatric cohort.
Authors: Witt Olaf , Geoerger Birgit , Dirksen Uta , Farouk Sait Sameer , Reardon David A. , Shih Kent C. , Diez Blanca D. , Monteiro Caran Eliana Maria , Karakawa Shuhei , Stuyckens Kim , Liao Huimin , Najmi Saltanat , Hammond Constance , Santiago-Walker Ademi E. , Sweiti Hussein
Published: June 2022

TPS10058

Background: FGFR gene alterations have been observed in pediatric patients with cancers and represent potentially targetable genomic variants. Gliomas (high- and low-grade) and soft tissue sarcomas are among the pediatric solid tumors that may harbor FGFR alterations. Erdafitinib is a selective pan-FGFR inhibitor approved in patients with locally advanced or metastatic urothelial carcinoma with susceptible FGFR2/3 alterations. RAGNAR (NCT04083976) is an ongoing single-arm, open-label, phase 2 histology-agnostic study investigating the efficacy and safety of erdafitinib in patients with advanced solid tumors exhibiting FGFR alterations after failure of standard systemic therapies. Here we describe the pediatric study cohort. Methods: The pediatric cohort (n = 26, planned) includes patients (≥ 6- < 18 y) with advanced solid tumors (measurable disease per RECIST v.1.1 or RANO [brain tumors]) with FGFR mutations, gene fusions, or internal tandem duplication (patients with FGFR amplification are not eligible) identified via local test reports or central molecular testing. Eligible patients will have received ≥ 1 lines of prior systemic therapy, have exhausted or be unable to tolerate standard-of-care therapies, and have documented disease progression and measurable disease. In addition, up to 6 patients in this cohort will be allowed to be treatment naive. Children and adolescents will be treated with oral erdafitinib, allowing pharmacodynamically guided uptitration based on serum phosphate levels to maximize efficacy. Treatment will continue until progressive disease. The primary end point is overall response rate (ORR) assessed by an independent review committee. Secondary efficacy end points include ORR assessed by the investigator, duration of response, disease control rate, clinical benefit rate, progression-free survival, and overall survival. Other secondary end points are pharmacokinetic exposure parameters, incidence/severity of adverse events, and change from baseline in patient-reported health status. End-of-treatment visit will occur 30 days after the last dose of erdafitinib. A follow-up phase will continue until death, withdrawal of consent, loss to follow-up, or end of study. As of January 2022, 3 patients have been enrolled. Clinical trial information: NCT04083976.
CaboMain: A phase 2 study of cabozantinib as a maintenance agent in patients with ultra-high risk pediatric solid tumors.
Authors: Shah Nilay
Published: June 2022

TPS10060

Background: Patients with relapsed or refractory pediatric solid tumors have one-year progression-free survival (PFS) <25% even if a remission is achieved [1-9]. Maintenance treatments may extend survival for these patients but have not been tested. Many tyrosine kinase inhibitors (TKIs) target oncogenic pathways active in pediatric cancers and are being evaluated in children with cancer. The multitargeted TKI cabozantinib inhibits MET, VEGFR, AXL, RET, ROS1, KIT, TRKB, FLT3, and TIE2. Preclinical studies and clinical use suggest that cabozantinib may be active against childhood cancers [10-20]. A pediatric Phase 1 study defined a dose of 40 mg/m2/day[21], currently used in an ongoing pediatric Phase 2 study for measurable relapsed/refractory solid tumors, NCT02867592. However, cabozantinib has not been tested as a maintenance agent against cancers in children. We hypothesize that cabozantinib, in patients with ultra-high-risk pediatric solid tumors with minimal disease burden, can prevent recurrent tumor formation or induce a durable remission. Methods: Trial Design: Single arm, open-label, multisite investigator-initiated Phase 2 trial for patients with a “best response,” defined as no progression at least 28 days after end of prior therapy. Primary objective: Evaluate the effect of cabozantinib administered for up to 12 months on 1-year PFS. Statistical design and measure: Bayesian time-to-event optimal phase 2 design with a single interim analysis designed to detect 20% increase in PFS at 1 year with 80% power. Secondary objectives include 2- and 5-year PFS; 1-, 2-, and 5- year OS, duration of response, and safety and tolerability. Exploratory objectives include patient-reported outcomes, predictive biomarkers, PK and PD measurements. Treatment: Patients will take cabozantinib tablets on a continuous dosing schedule, partitioned into 28-day cycles, at an initial dose of 40 mg/m2/day (per dosing nomogram), for up to 365 days. Assessments are defined; radiographic assessment every 3 cycles. Dose modifications will be based on toxicities per protocol. Patients will continue on therapy until progression, toxicities not relieved by dose reduction, or end of planned therapy. Major eligibility criteria: Three strata: Neuroblastoma with residual disease at end of upfront therapy (“Best Response 1”, BR1) or after any relapse, n=36. Pediatric CNS tumors, defined in the protocol, n=30. Other pediatric solid tumors, as defined in the protocol, n=36. Patients must be ≥ 18 months and ≤40 years of age at enrollment, have completed prior therapy ≥ 4 weeks and ≤ 12 weeks prior to enrollment and demonstrate radiographic BR at time of enrollment. Measurable or evaluable disease is not required. Enrollment: Protocol is open to enrollment as of February 12, 2022. At time of abstract submission, we have not yet enrolled the first patient. Clinical trial information: NCT05135975.
Phase 3 study of tucatinib or placebo in combination with trastuzumab and pertuzumab as maintenance therapy for HER2+ metastatic breast cancer (HER2CLIMB-05, trial in progress).
Authors: Hamilton Erika P. , O'Sullivan Ciara Catherine Maria , Martin Miguel , Sohn Joohyuk , Tryfonidis Konstantinos , Santarpia Libero , Yang Shan , Dieras Veronique C
Published: June 2022

TPS1108

Background: The current first-line (1L) standard of care (SOC) for human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer (MBC) is trastuzumab (T) plus pertuzumab (P) and a taxane. Despite advances in 1L SOC, most patients (pts) progress during maintenance therapy with T+P. Tucatinib is a tyrosine kinase inhibitor (TKI) approved in combination with T and capecitabine for adults with HER2+ MBC, with and without brain metastases (BM). In HER2CLIMB, the addition of tucatinib significantly prolonged progression-free survival (PFS) and overall survival (OS) in pts with HER2+ MBC and was well tolerated. Adding tucatinib also reduced the risk of disease progression or death in pts with untreated and/or active BM (Murthy et al. 2020, Curigliano et al. 2021). HER2CLIMB-05 investigates whether adding tucatinib to 1L SOC as maintenance therapy will extend PFS while maintaining quality of life (QOL). Methods: HER2CLIMB-05 (NCT05132582) is a phase 3, randomized, double-blind study evaluating tucatinib plus T+P as maintenance therapy for HER2+ MBC. Approximately 650 pts will be enrolled. Eligible pts will have advanced HER2+ disease, no progression on 4–8 cycles of prior 1L SOC, ECOG Performance Status of 0 or 1, and no or asymptomatic BM. Exclusion criteria include prior treatment with anti-HER2 and/or anti-epidermal growth factor receptor TKI (prior SOC for early BC is permitted) or inability to undergo contrast magnetic resonance imaging of the brain. Pts will be randomized 1:1 to receive either tucatinib or placebo twice daily, with T+P once every 21 days. Pts with HR+ disease may receive endocrine therapy. The primary endpoint is investigator-assessed PFS. Secondary endpoints include OS (key endpoint), time to deterioration of health-related QOL, central nervous system PFS, safety, and pharmacokinetic (PK) parameters. PFS and OS will be compared using a 2-sided stratified log-rank test between treatment groups. Time-to-event endpoints will be summarized using the Kaplan–Meier method. PK and safety data will be summarized using descriptive statistics. Enrollment is ongoing in the US, with additional sites planned. Clinical trial information: NCT05132582.