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1.
Emerg Infect Dis ; 30(4): 757-760, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38526137

ABSTRACT

Analyzing vaccine stability under different storage and transportation conditions is critical to ensure that effectiveness and safety are not affected by distribution. In a simulation of the last mile in the supply chain, we found that shock and vibration had no effect on Ad26.ZEBOV/MVA-BN-Filo Ebola vaccine regimen quality under refrigerated conditions.


Subject(s)
Ebola Vaccines , Ebolavirus , Hemorrhagic Fever, Ebola , Humans , Hemorrhagic Fever, Ebola/prevention & control , Vibration , Computer Simulation , Antibodies, Viral
2.
J Natl Compr Canc Netw ; 21(8): 851-880, 2023 08.
Article in English | MEDLINE | ID: mdl-37549914

ABSTRACT

This selection from the NCCN Guidelines for Adolescent and Young Adult (AYA) Oncology focuses on considerations for the comprehensive care of AYA patients with cancer. Compared with older adults with cancer, AYA patients have unique needs regarding treatment, fertility counseling, psychosocial and behavioral issues, and supportive care services. The complete version of the NCCN Guidelines for Adolescent and Young Adult (AYA) Oncology addresses additional aspects of caring for AYA patients, including risk factors, screening, diagnosis, and survivorship.


Subject(s)
Medical Oncology , Neoplasms , Humans , Adolescent , Young Adult , Aged , Neoplasms/diagnosis , Neoplasms/therapy , Neoplasms/psychology , Counseling , Survivorship , Risk Factors
3.
CA Cancer J Clin ; 66(1): 43-73, 2016.
Article in English | MEDLINE | ID: mdl-26641959

ABSTRACT

Answer questions and earn CME/CNE The purpose of the American Cancer Society/American Society of Clinical Oncology Breast Cancer Survivorship Care Guideline is to provide recommendations to assist primary care and other clinicians in the care of female adult survivors of breast cancer. A systematic review of the literature was conducted using PubMed through April 2015. A multidisciplinary expert workgroup with expertise in primary care, gynecology, surgical oncology, medical oncology, radiation oncology, and nursing was formed and tasked with drafting the Breast Cancer Survivorship Care Guideline. A total of 1073 articles met inclusion criteria; and, after full text review, 237 were included as the evidence base. Patients should undergo regular surveillance for breast cancer recurrence, including evaluation with a cancer-related history and physical examination, and should be screened for new primary breast cancer. Data do not support performing routine laboratory tests or imaging tests in asymptomatic patients to evaluate for breast cancer recurrence. Primary care clinicians should counsel patients about the importance of maintaining a healthy lifestyle, monitor for post-treatment symptoms that can adversely affect quality of life, and monitor for adherence to endocrine therapy. Recommendations provided in this guideline are based on current evidence in the literature and expert consensus opinion. Most of the evidence is not sufficient to warrant a strong evidence-based recommendation. Recommendations on surveillance for breast cancer recurrence, screening for second primary cancers, assessment and management of physical and psychosocial long-term and late effects of breast cancer and its treatment, health promotion, and care coordination/practice implications are made.


Subject(s)
Breast Neoplasms/therapy , Survivors , Adult , Aged , American Cancer Society , Body Image , Breast Neoplasms/complications , Breast Neoplasms/psychology , Early Detection of Cancer , Female , Genetic Counseling , Humans , Medical History Taking , Middle Aged , Neoplasm Recurrence, Local/diagnosis , Neoplasms, Second Primary/diagnosis , Physical Examination , Quality of Life , Risk Assessment , Survivors/psychology , United States , Young Adult
4.
Pediatr Blood Cancer ; 68(3): e28884, 2021 03.
Article in English | MEDLINE | ID: mdl-33416214

ABSTRACT

BACKGROUND: Self-management interventions for adolescent and young adult (AYA) survivors of childhood cancer are needed. The present study reports on the acceptability and feasibility of delivering survivorship care plans (SCPs) and an accompanying app to AYA. PROCEDURE: AYA (n = 224) ages 15-29 who completed treatment for cancer were randomized and received a digital SCP only or an SCP plus a mobile app intended to enhance self-management. For 16 weeks, the app delivered one to two daily messages complementing information in their SCP and tailored based on age, treatment, and health goal. Data are presented on feasibility, self-reported acceptability (including satisfaction and perceived benefits) and its relationship to app engagement (for those in app group), and feedback from qualitative interviews conducted with 10 AYA. RESULTS: The SCP and app proved feasible as evidenced by high recruitment and retention, access to technology, time analysis, moderate app engagement, and minimal technical issues. However, 12% reported never reading the SCP and 8% never used the app. The app and SCP were acceptable to AYA, and SCP acceptability ratings did not differ between groups. For those with the app, acceptability was positively related to message engagement. AYA recommended enhanced individualization and design features of the SCP and app. CONCLUSIONS: Results support the use of tailored SCPs and mobile health interventions for most AYA, as well as the need for further refinement and research. Delivery of SCPs and digital interventions are acceptable and feasible to AYA survivors, and may help promote health-related knowledge and survivorship self-management.


Subject(s)
Cancer Survivors/statistics & numerical data , Health Promotion , Mobile Applications/statistics & numerical data , Neoplasms/prevention & control , Patient Care Planning/standards , Survivorship , Adolescent , Adult , Child , Feasibility Studies , Female , Follow-Up Studies , Humans , Male , Motivation , Prognosis , Survival Rate , Young Adult
5.
Cancer ; 125(11): 1908-1917, 2019 06 01.
Article in English | MEDLINE | ID: mdl-30707763

ABSTRACT

BACKGROUND: The impact of cancer and its treatment on employment and financial burden in adolescents/young adults (AYAs) is not fully known. METHODS: Eligibility for this cross-sectional study of AYA cancer survivors included the diagnosis of a malignancy between ages 18 and 39 years and survey completion within 1 to 5 years from diagnosis and ≥1 year after therapy completion. Participants were selected randomly from the tumor registries of 7 participating sites and completed an online patient-reported outcomes survey to assess employment and financial concerns. Treatment data were abstracted from medical records. Data were analyzed across diagnoses and by tumor site using logistic regression and Wald-based 95% confidence intervals adjusting for age (categorized), sex, insurance status, education (categorized), and treatment exposures. RESULTS: Participants included 872 survivors (breast cancer, n = 241; thyroid cancer, n = 126; leukemia/lymphoma, n = 163; other malignancies, n = 342). Exposure to chemotherapy in breast cancer survivors was associated with an increase in self-reported mental impairment in work tasks (odds ratio [OR], 2.66) and taking unpaid time off (OR, 2.62); survivors of "other" malignancies reported an increase in mental impairment of work tasks (OR, 3.67) and borrowing >$10,000 (OR, 3.43). Radiation exposure was associated with an increase of mental impairment in work tasks (OR, 2.05) in breast cancer survivors, taking extended paid time off work in thyroid cancer survivors (OR, 5.05), and physical impairment in work tasks in survivors of "other" malignancies (OR, 3.11). Finally, in survivors of "other" malignancies, having undergone surgery was associated with an increase in physical (OR, 3.11) and mental impairment (OR, 2.31) of work tasks. CONCLUSIONS: Cancer treatment has a significant impact on AYA survivors' physical and mental work capacity and time off from work.


Subject(s)
Cancer Survivors/psychology , Neoplasms/economics , Neoplasms/therapy , Unemployment/statistics & numerical data , Adolescent , Adult , Cost of Illness , Cross-Sectional Studies , Female , Financing, Personal , Humans , Logistic Models , Male , Patient Reported Outcome Measures , Young Adult
6.
Lancet Oncol ; 18(1): e19-e29, 2017 01.
Article in English | MEDLINE | ID: mdl-28049574

ABSTRACT

Attention to survivors of adult cancers formally began more than 30 years ago with the founding of the National Coalition for Cancer Survivorship by representatives from 20 organisations who envisioned an organisation that would address survivorship issues and include friends, family, and caregivers. Since then, progress has been made in cancer care delivery, which has created challenges for and barriers to provision of optimal follow-up care to patients and survivors living with cancer as a chronic illness. Focus on post-treatment cancer care, including monitoring for long-term and late effects, and concerns regarding the effect of a cancer diagnosis and treatment on quality of life have gained momentum in the past 10 years. This impetus is largely a result of the 2005 Institute of Medicine Report From Cancer Patient to Cancer Survivor: Lost in Transition. Although the issues raised in the report were hardly novel, they gave a new and powerful voice to the cancer survivorship movement that demanded a call to action. In this Series paper, we provide an overview of the issues surrounding provision of cancer survivorship and follow-up care in the USA and discuss potential solutions to these challenges.


Subject(s)
Aftercare , Continuity of Patient Care , Neoplasms/therapy , Quality of Health Care/standards , Survivors , Adult , Humans
7.
Support Care Cancer ; 25(8): 2405-2412, 2017 08.
Article in English | MEDLINE | ID: mdl-28233121

ABSTRACT

PURPOSE: Survivor distress is well represented in the literature, but less is known about survivors' concerns and how these relate to adaptation. Using a newly designed Survivorship Concern Scale, we examined concerns and their relationship to psychosocial adaptation among recent breast cancer (BC) survivors. METHODS: One hundred forty-three stage 0-III BC survivors completed an online assessment including the Survivorship Concern Scale (0-3 scale; alpha = 0.91), unmet needs, quality of life (QoL), and anxiety and depressive symptoms within 1 year of end of treatment. RESULTS: Participants were predominately white (76%), middle-aged (51 years), married (70%), and college educated (79%). Eighty-two percent were stage I or II at diagnosis. Mean degree of survivorship concern was moderate (M = 1.75, SD = 0.70) though variable (range = 0.12-3.00). Survivorship concerns were not significantly related to disease, treatment, or demographic variables except income (p = 0.02). Degree of survivorship concern was significantly associated with all indices of psychosocial adaptation: unmet need (r = 0.50), physical and mental QoL (r = -0.32 and r = -0.32, respectively), depressive symptoms (r = 0.21), and anxiety symptoms (r = 0.51; all p < 0.001). Binary logistic regression suggested that each one-point increase in degree of average concern increased the odds for elevated depressive symptoms by 2.83 (p = 0.03) and increased the odds of elevated anxiety symptoms by 3.69 (p < 0.001). CONCLUSIONS: Survivorship concerns in the year following treatment are moderate but variable. Concerns are associated with QoL, unmet need, and psychosocial adaptation. Adequately addressing concerns may be a way to improve psychosocial outcomes early in the survivorship trajectory.


Subject(s)
Breast Neoplasms/psychology , Patient Reported Outcome Measures , Quality of Life/psychology , Female , Humans , Male , Middle Aged , Surveys and Questionnaires , Survival Rate , Survivors/psychology
8.
CA Cancer J Clin ; 59(6): 391-410, 2009.
Article in English | MEDLINE | ID: mdl-19897841

ABSTRACT

Increases in the number of adult cancer survivors and other issues have forced the oncology community to examine, evaluate, and alter the cancer care paradigm. Pediatric oncologists are grappling with the task of transitioning a growing population of adult survivors of childhood cancer to adult medicine, while oncologists caring for adult cancer survivors are seeking models of follow-up care that are acceptable to patients and providers. Workforce and access-to-care issues suggest that primary care providers will see more cancer survivors in their practices across time, although it is unclear how prepared they are for this task. Translational research is needed to develop evidence-based clinical care and survivorship care plans. A broad picture of the evolving field of adult cancer survivorship is presented. The recent focus on young adult survivors of childhood cancer, an overview of translational research needed to inform the physical and psychosocial care of cancer survivors, and the roles of primary and specialty care providers managing this population is examined. Finally, an overview of evolving treatment summary and care plan initiatives is presented.


Subject(s)
Continuity of Patient Care , Neoplasms/therapy , Survivors , Adult , Child , Health Behavior , Health Education , Humans , Internet , Neoplasms/psychology , Patient Care Planning
9.
BMC Fam Pract ; 16: 143, 2015 Oct 20.
Article in English | MEDLINE | ID: mdl-26486311

ABSTRACT

BACKGROUND: Helping cancer survivors to transition from active treatment to long-term survivorship requires coordinated efforts by both oncologists and primary care physicians (PCPs). This study aims to evaluate cancer survivors' perspectives on PCP-delivered survivorship care. METHODS: We conducted an Internet-based cross-sectional survey of cancer survivors via www.OncoLink.org . Regression analyses were used to identify factors associated with perception of PCP-delivered survivorship care. RESULTS: The 352 respondents rated overall PCP-delivered survivorship care as 60 out of 100 (SD = 23). The areas of care most strongly endorsed were general care (62 %), psychosocial support (65 %), and holistic care (68 %). Survivors were less likely to perceive their PCPs as knowledgeable about cancer follow-up (43 %), late or long-term effects of cancer therapy (45 %), and diagnosis and treatment of symptoms related to cancer or cancer therapy (42 %). While 72 % of survivors reported satisfaction with their PCP's care overall, only 41 % felt that their PCPs and oncologists communicated well with one another. In a multivariate regression analysis, higher trust in PCP (p < 0.001), non-white race (p = 0.001), living in the United States (p = 0.007), and visiting a PCP two or more times per year (p = 0.009) were significantly associated with higher ratings of PCP-delivered survivorship care. CONCLUSIONS: While cancer survivors in general are satisfied with care delivery by PCPs, they perceived that their PCPs have limited abilities in performing cancer-specific follow-up and late effect monitoring and treatment. Better education of family physicians about survivorship issues and improved communication between PCPs and oncologists are needed to improve PCPs' delivery of survivorship care.


Subject(s)
Neoplasms/therapy , Physicians, Primary Care , Survivors/psychology , Cross-Sectional Studies , Female , Humans , Male , Middle Aged , Physicians, Primary Care/standards , Quality of Health Care/standards , Surveys and Questionnaires
10.
Europace ; 16(8): 1197-204, 2014 Aug.
Article in English | MEDLINE | ID: mdl-24489074

ABSTRACT

AIMS: To assess the influence of device-registered episodes of atrial tachyarrhythmia (AT) on the response to cardiac resynchronization therapy (CRT). METHODS AND RESULTS: Consecutive CRT patients without history of atrial fibrillation (AF; n = 118) were followed prospectively. AT was defined as a device-registered episode of atrial rate >190 b.p.m. for ≥30 s. Episodes of electrocardiographically documented AF, accompanied by symptoms, or need for cardioversion, were classified as clinical AF. During mean follow-up of 26 ± 9 months, 39 patients (33%) had ≥1 episode of asymptomatic device-registered AT. Twenty-one patients (18%) developed clinical AF of whom seven had previously experienced episodes of asymptomatic device-registered AT. Patients with asymptomatic AT or AF had a higher body mass index, but otherwise similar baseline characteristics, compared with the subjects without AT. Reverse remodelling after CRT was similar among the groups. While clinical AF was significantly associated with the composite endpoint of all-cause mortality or unplanned hospital admission (hazard ratio = 2.43, 95% confidence interval: 1.40-4.24), this correlation was not observed in patients with asymptomatic device-registered AT (P value = 0.540). CONCLUSION: Episodes of asymptomatic device-registered AT are frequent in CRT patients, but are not associated with impaired reverse remodelling. In contrast to clinical AF, such episodes are not associated with worse clinical outcome.


Subject(s)
Atrial Fibrillation/epidemiology , Cardiac Resynchronization Therapy Devices , Cardiac Resynchronization Therapy , Heart Failure/therapy , Tachycardia, Supraventricular/epidemiology , Asymptomatic Diseases , Atrial Fibrillation/diagnosis , Atrial Fibrillation/mortality , Atrial Fibrillation/physiopathology , Atrial Fibrillation/therapy , Belgium/epidemiology , Cardiac Resynchronization Therapy/adverse effects , Cardiac Resynchronization Therapy/mortality , Electric Countershock , Electrocardiography , Heart Failure/diagnosis , Heart Failure/mortality , Heart Failure/physiopathology , Heart Rate , Humans , Predictive Value of Tests , Prospective Studies , Risk Factors , Tachycardia, Supraventricular/diagnosis , Tachycardia, Supraventricular/mortality , Tachycardia, Supraventricular/physiopathology , Tachycardia, Supraventricular/therapy , Time Factors , Treatment Outcome
11.
Support Care Cancer ; 22(6): 1475-83, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24414997

ABSTRACT

PURPOSE: The Institute of Medicine (IOM) and Commission on Cancer have called for provision of treatment summaries (TSs) and survivorship care plans (SCPs) at the end of primary cancer therapy and endorsed guidelines for content. Institutions are providing TS/SCPs but with little guidance concerning concordance with IOM recommended content. This manuscript presents a recently developed tool to allow rating of breast cancer-specific TS/SCPs as a model for assessing concordance with IOM recommendations and facilitating research and clinical fidelity. METHOD: An interdisciplinary team developed items mapped to the IOM recommendations for TS/SCP content as well as scoring rules. Dual raters used this tool to independently assess 65 completed TS/SCPs from 13 different cancer treatment facilities affiliated with the LIVESTRONG Survivorship Centers of Excellence to assess reliability. RESULTS: The final set of measures contained 92 items covering TSs and SCPs. The TS scale consisted of 13 informational domains across 60 items, while the SCP scale had 10 domains across 32 items. Inter-rater reliability within TSs indicated substantial agreement (M kappa = 0.76, CI = 0.73-0.79), and interclass correlation (ICC) was high (ICC = 0.85, CI = 0.76-0.91). For the SCP scale, inter-rater reliability was also substantial (M kappa = 0.66, CI = 0.62-0.70), as was interclass correlation (ICC = 0.75, CI = 0.62-0.84). CONCLUSION: Concordance with IOM recommendations for TS/SCP information can be reliably assessed using this instrument, which should facilitate implementation efforts, allow comparison of different TS/SCPs, and facilitate research into the utility of TS/SCPs including which elements are essential.


Subject(s)
Breast Neoplasms/therapy , Patient Care Planning/standards , Patient Care Team , Breast Neoplasms/rehabilitation , Female , Humans , Reproducibility of Results , Survivors , United States
12.
Acta Cardiol ; 69(2): 145-54, 2014 Apr.
Article in English | MEDLINE | ID: mdl-24783465

ABSTRACT

OBJECTIVE: The objective of this study was to assess the feasibility and impact on readmissions of transmural disease management across the borders of the cardiology department in patients with advanced heart failure (HF). METHODS AND RESULTS: Consecutive patients, readmitted within one year for advanced HF by a dedicated specialist (n = 55), were followed for 22 +/- 10 months after implementation of a hospitalwide transmural disease management strategy. Participants received a tag in their electronic medical record, triggering a HF caregiver contact, with subsequent guideline-recommended, protocol-driven care on each cardiac or non-cardiac hospitalization as well as outpatient evaluation. Upon transition to outpatient follow-up, patients were instructed to call the HF caregiver with any question at low threshold. Readmission rates were prospectively collected. Despite receiving adequate treatment with neurohumoral blockers, patients (71 +/- 11 years; ejection fraction 35 +/- 13%) had spent 4% (27%) of the year preceding study inclusion in hospital, with 73% admitted once, 20% twice, and 7% more than twice for acute decompensated HF (ADHF). During the study, patients were exposed to 6 +/- 4 dedicated HF caregiver contacts. Participation in remote device monitoring increased from 31% to 92%, with 1 (0-3) additional phone contacts per patient-year of follow-up in this subgroup (n = 24). All-cause mortality and readmission rates for ADHF were 10% and 25% after one year, and 19% and 39% after 2 years, respectively. Follow-up time spent in hospital decreased significantly to 2% (16%) (P value = 0.047). CONCLUSIONS: Follow-up of advanced HF patients through transmural disease management is feasible and associated with favourable clinical outcome.


Subject(s)
Cardiotonic Agents/therapeutic use , Diuretics/therapeutic use , Heart Failure/therapy , Aged , Aged, 80 and over , Ambulatory Care , Belgium/epidemiology , Cardiology Service, Hospital , Disease Management , Drug Therapy, Combination , Feasibility Studies , Female , Follow-Up Studies , Heart Failure/diagnosis , Heart Failure/epidemiology , Heart Failure/physiopathology , Hospitals, University , Humans , Incidence , Inpatients/statistics & numerical data , Length of Stay/statistics & numerical data , Male , Middle Aged , Patient Readmission/statistics & numerical data , Patient Transfer/statistics & numerical data , Practice Guidelines as Topic , Prospective Studies , Risk Assessment , Severity of Illness Index , Surveys and Questionnaires , Treatment Outcome
13.
J Cancer Surviv ; 18(1): 29-33, 2024 02.
Article in English | MEDLINE | ID: mdl-38294601

ABSTRACT

The Cancer Survivorship Program was established at the University of Pennsylvania Cancer Center in 2001. The Cancer Center was renamed the Abramson Cancer Center of the University of Pennsylvania in 2002 and the survivorship program was henceforth known as the ACC Survivorship Program. The program was supported from 2001 to 2004 in part by a seed grant from the Lance Armstrong Foundation (LAF). The LIVESTRONG Survivorship Centers of Excellence Network was created by the LAF in 2005 and the ACC Survivorship Program joined the Network in 2007. The seven nationwide Cancer Centers that comprised the Network were supported by the LAF through 2015. A focus on clinical care, research, and education led the development of the ACC Survivorship Program. The program is currently led by an advanced practice provider (APP) and staffed by medical, surgical, and radiation oncology APPs and collaborating oncologists. This program provides care to adult survivors of pediatric cancers, as well as survivors of adult-onset cancers such as breast, genitourinary/prostate, lymphoma, head and neck, gastrointestinal, thoracic, sarcoma, and central nervous system. Research protocols for survivors of specific cancer diagnoses have been developed and have resulted in collaborative research, publications, and conference presentations. Sustaining the ACC Survivorship Program has been challenging despite strong endorsement of services by patients, families, and providers. Challenges include barriers such as cost restraints, changing cancer center priorities, and a reduced oncology workforce, issues experienced across the country that must be addressed in the years to come.


Subject(s)
Cancer Survivors , Neoplasms , Sarcoma , Male , Adult , Child , Humans , Neoplasms/therapy , Survivors , Medical Oncology/education , Survivorship
14.
JCO Oncol Pract ; 20(4): 483-490, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38237102

ABSTRACT

PURPOSE: Capecitabine is an oral chemotherapy used to treat many gastrointestinal cancers. Its complex dosing and narrow therapeutic index make medication adherence and toxicity management crucial for quality care. METHODS: We conducted a pilot study of PENNY-GI, a mobile phone text messaging-based chatbot that leverages algorithmic surveys and natural language processing to promote medication adherence and toxicity management among patients with gastrointestinal cancers on capecitabine. Eligibility initially included all capecitabine-containing regimens but was subsequently restricted to capecitabine monotherapy because of challenges in integrating PENNY-GI with radiation and intravenous chemotherapy schedules. We used design thinking principles and real-time data on safety, accuracy, and usefulness to make iterative refinements to PENNY-GI with the goal of minimizing the proportion of text messaging exchanges with incorrect medication or symptom management recommendations. All patients were invited to participate in structured exit interviews to provide feedback on PENNY-GI. RESULTS: We enrolled 40 patients (median age 64.5 years, 52.5% male, 62.5% White, 55.0% with colorectal cancer, 50.0% on capecitabine monotherapy). We identified 284 of 3,895 (7.3%) medication-related and 13 of 527 (2.5%) symptom-related text messaging exchanges with incorrect recommendations. In exit interviews with 24 patients, participants reported finding the medication reminders reliable and user-friendly, but the symptom management tool was too simplistic to be helpful. CONCLUSION: Although PENNY-GI provided accurate recommendations in >90% of text messaging exchanges, we identified multiple limitations with respect to the intervention's generalizability, usefulness, and scalability. Lessons from this pilot study should inform future efforts to develop and implement digital health interventions in oncology.


Subject(s)
Cell Phone , Gastrointestinal Neoplasms , Humans , Male , Middle Aged , Female , Capecitabine/pharmacology , Capecitabine/therapeutic use , Pilot Projects , Medication Adherence
15.
Hum Vaccin Immunother ; 20(1): 2327747, 2024 Dec 31.
Article in English | MEDLINE | ID: mdl-38523332

ABSTRACT

This phase-3, double-blind, placebo-controlled study (NCT04228783) evaluated lot-to-lot consistency of the Ad26.ZEBOV, MVA-BN-Filo Ebola vaccine regimen. Participants were randomized (6:6:6:1) to receive the two-dose regimen from three consecutively manufactured lots of Ad26.ZEBOV on Day 1 paired with three consecutively manufactured lots of MVA-BN-Filo on Day 57 (Groups 1-3) or two doses of placebo (Group 4). An additional cohort also received an Ad26.ZEBOV booster or placebo 4 months post-dose 2. Equivalence of the immunogenicity at 21 days post-dose 2 between any two groups was demonstrated if the 95% confidence interval (CI) of the Ebola virus glycoprotein (EBOV GP)-binding antibody geometric mean concentration (GMC) ratio was entirely within the prespecified margin of 0.5-2.0. Lot-to-lot consistency (i.e., consecutive lots can be consistently manufactured) was accomplished if equivalence was shown for all three pairwise comparisons. Results showed that the primary objective in the per-protocol immunogenicity subset (n = 549) was established for each pairwise comparison (Group 1 vs 2: GMC ratio = 0.9 [95% CI: 0.8, 1.1], Group 1 vs 3: 0.9 [0.8, 1.1], Group 2 vs 3: 1.0 [0.9, 1.2]). Equivalence of the three groups for the Ad26.ZEBOV component only was also demonstrated at 56 days post-dose 1. EBOV GP-binding antibody responses (post-vaccination concentrations >2.5-fold from baseline) were observed in 419/421 (99.5%) vaccine recipients at 21 days post-dose 2 and 445/460 (96.7%) at 56 days post-dose 1. In the booster cohort (n = 39), GMCs increased 9.0- and 11.8-fold at 7 and 21 days post-booster, respectively, versus pre-booster. Ad26.ZEBOV, MVA-BN-Filo was well tolerated, and no safety issues were identified.


Subject(s)
Ebola Vaccines , Ebolavirus , Hemorrhagic Fever, Ebola , Smallpox Vaccine , Humans , Hemorrhagic Fever, Ebola/prevention & control , Vaccination/methods , Antibodies, Viral , Double-Blind Method , Immunogenicity, Vaccine , Vaccines, Attenuated
16.
Eur Urol ; 85(4): 337-345, 2024 Apr.
Article in English | MEDLINE | ID: mdl-37246069

ABSTRACT

BACKGROUND: Testicular germ cell tumor (TGCT) is the most common cancer among young White men. TGCT is highly heritable, although there are no known high-penetrance predisposition genes. CHEK2 is associated with moderate TGCT risk. OBJECTIVE: To identify coding genomic variants associated with predisposition to TGCT. DESIGN, SETTING, AND PARTICIPANTS: The study involved 293 men with familial or bilateral (high risk; HR)-TGCT representing 228 unique families and 3157 cancer-free controls. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: We carried out exome sequencing and gene burden analysis to identify associations with TGCT risk. RESULTS AND LIMITATIONS: Gene burden association identified several genes, including loss-of-function variants of NIN and QRSL1. We identified no statistically significant association with the sex- and germ-cell development pathways (hypergeometric overlap test: p = 0.65 for truncating variants, p = 0.47 for all variants) or evidence of associations with the regions previously identified via genome-wide association studies (GWAS). When considering all significant coding variants together with genes associated with TGCT on GWAS, there were associations with three major pathways: mitosis/cell cycle (Gene Ontology identity GO:1903047: observed/expected variant ratio [O/E] 6.17, false discovery rate [FDR] 1.53 × 10-11), co-translational protein targeting (GO:0006613: O/E 18.62, FDR 1.35 × 10-10), and sex differentiation (GO:0007548: O/E 5.25, FDR 1.90 × 10-4). CONCLUSIONS: To the best of our knowledge, this study is the largest to date on men with HR-TGCT. As in previous studies, we identified associations with variants for several genes, suggesting multigenic heritability. We identified associations with co-translational protein targeting, and chromosomal segregation and sex determination, identified via GWAS. Our results suggest potentially druggable targets for TGCT prevention or treatment. PATIENT SUMMARY: We searched for gene variations that increase the risk of testicular cancer and found numerous new specific variants that contribute to this risk. Our results support the idea that many gene variants inherited together contribute to the risk of testicular cancer.


Subject(s)
Neoplasms, Germ Cell and Embryonal , Testicular Neoplasms , Male , Humans , Testicular Neoplasms/genetics , Testicular Neoplasms/pathology , Genetic Predisposition to Disease , Genome-Wide Association Study , Exome Sequencing , Case-Control Studies , Neoplasms, Germ Cell and Embryonal/genetics , Germ Cells/pathology
17.
J Natl Cancer Inst Monogr ; 2024(64): 62-69, 2024 Jun 26.
Article in English | MEDLINE | ID: mdl-38924794

ABSTRACT

Drawing from insights from communication science and behavioral economics, the University of Pennsylvania Telehealth Research Center of Excellence (Penn TRACE) is designing and testing telehealth strategies with the potential to transform access to care, care quality, outcomes, health equity, and health-care efficiency across the cancer care continuum, with an emphasis on understanding mechanisms of action. Penn TRACE uses lung cancer care as an exemplar model for telehealth across the care continuum, from screening to treatment to survivorship. We bring together a diverse and interdisciplinary team of international experts and incorporate rapid-cycle approaches and mixed methods evaluation in all center projects. Our initiatives include a pragmatic sequential multiple assignment randomized trial to compare the effectiveness of telehealth strategies to increase shared decision-making for lung cancer screening and 2 pilot projects to test the effectiveness of telehealth to improve cancer care, identify multilevel mechanisms of action, and lay the foundation for future pragmatic trials. Penn TRACE aims to produce new fundamental knowledge and advance telehealth science in cancer care at Penn and nationally.


Subject(s)
Lung Neoplasms , Telemedicine , Humans , Pennsylvania , Lung Neoplasms/therapy , Lung Neoplasms/diagnosis , Universities , Early Detection of Cancer/methods , Pilot Projects
18.
Cancer ; 119(21): 3854-60, 2013 Nov 01.
Article in English | MEDLINE | ID: mdl-23922002

ABSTRACT

BACKGROUND: Survivorship care plans (SCP) are currently recommended by the Institute of Medicine, and will soon be required for accreditation by the American College of Surgeons Commission on Cancer. To the best of the authors' knowledge, the impact of SCPs on cancer survivors has not been previously reported. METHODS: In 2007, the authors created an Internet tool for the creation of SCPs that provides customized guidelines for survivorship care. Users are sent a voluntary follow-up survey 1 month after initial use. RESULTS: From May 2010 through January 2013, 8690 cancer survivors used the SCP tool. The most common diagnoses were breast (45%), hematologic (12%), and gastrointestinal (11%) cancers; the median age of the survivors was 51 years. Of these, 875 (10%) respondents provided information for future electronic contact and 298 responded to a 1-month follow-up survey. They reported that the information provided was "good" to "excellent" in 93% of cases, and new in 65% of cases. With regard to the emotional impact of the SCP, 62% of responding survivors believed that it provided "just enough" information, 72% felt "more informed," and 94% believed they would recommend it to others. The majority of respondents (63%) thought that the SCP changed their health care participation, and 80% shared/planned to share it with their health care team. Of those survivors who had done so, 80% reported that it improved communication with their health care providers. Greater than one-half of survey users (54%) reported that they had made or planned to make a lifestyle change in response to the SCP, most commonly dietary modification and increased exercise. CONCLUSIONS: Survivorship care plans are useful vehicles with which to promote lifestyle and behavioral changes, and to assist survivors with communication with health care providers. These findings support recommendations from the Institute of Medicine and the American College of Surgeons Commission on Cancer.


Subject(s)
Health Behavior , Internet/statistics & numerical data , Life Style , Neoplasms/mortality , Neoplasms/rehabilitation , Patient Care Planning/statistics & numerical data , Adult , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Patient Acceptance of Health Care/statistics & numerical data , Surveys and Questionnaires , Survival Rate , Survivors/psychology , Survivors/statistics & numerical data
19.
Cancer Causes Control ; 24(4): 695-704, 2013 Apr.
Article in English | MEDLINE | ID: mdl-23378138

ABSTRACT

PURPOSE: Recognition of the complex, multidimensional relationship between excess adiposity and cancer control outcomes has motivated the scientific community to seek new research models and paradigms. METHODS: The National Cancer Institute developed an innovative concept to establish a center grant mechanism in nutrition, energetics, and physical activity, referred to as the Transdisciplinary Research on Energetics and Cancer (TREC) Initiative. This paper gives an overview of the 2011-2016 TREC Collaborative Network and the 15 research projects being conducted at the centers. RESULTS: Four academic institutions were awarded TREC center grants in 2011: Harvard University, University of California San Diego, University of Pennsylvania, and Washington University in St. Louis. The Fred Hutchinson Cancer Research Center is the Coordination Center. The TREC research portfolio includes three animal studies, three cohort studies, four randomized clinical trials, one cross-sectional study, and two modeling studies. Disciplines represented by TREC investigators include basic science, endocrinology, epidemiology, biostatistics, behavior, medicine, nutrition, physical activity, genetics, engineering, health economics, and computer science. Approximately 41,000 participants will be involved in these studies, including children, healthy adults, and breast and prostate cancer survivors. Outcomes include biomarkers of cancer risk, changes in weight and physical activity, persistent adverse treatment effects (e.g., lymphedema, urinary and sexual function), and breast and prostate cancer mortality. CONCLUSION: The NIH Science of Team Science group will evaluate the value added by this collaborative science. However, the most important outcome will be whether this transdisciplinary initiative improves the health of Americans at risk of cancer as well as cancer survivors.


Subject(s)
Energy Metabolism , Interdisciplinary Communication , Neoplasms/prevention & control , Adolescent , Adult , Aged , Aged, 80 and over , Biomedical Research , Child , Child, Preschool , Clinical Trials as Topic , Cohort Studies , Cooperative Behavior , Epidemiologic Research Design , Female , Humans , Infant , Infant, Newborn , Male , Middle Aged , National Cancer Institute (U.S.) , National Institutes of Health (U.S.) , Neoplasms/epidemiology , Prognosis , Time Factors , United States/epidemiology , Young Adult
20.
J Sex Med ; 10 Suppl 1: 120-6, 2013 Feb.
Article in English | MEDLINE | ID: mdl-23387917

ABSTRACT

INTRODUCTION: There are over 13 million cancer survivors in the United States, which constitutes 3-4% of the U.S. population. According to the Surveillance Epidemiology and End Results program (SEER) data the 5-year overall survival rate for children diagnosed with cancer between ages 0-19 is 83.1%, and 2/3 of childhood cancer survivors will experience at least one late effect of treatment. AIM: To provide a brief overview of the medical and psychosocial effects of cancer treatments in survivors of childhood cancer with a focus on sexual and reproductive health issues in this population. METHODS: The development of a manuscript from a presentation at the Annual Society of Sexual Medicine meeting. An overview of long-term and late effects of treatment experienced by young adult cancer survivors was presented. MAIN OUTCOME MEASURE: This manuscript is based on a presentation that reviewed the medical and psychosocial literature, consensus statements of professional groups, and clinical observations. RESULTS: Cancer and cancer treatments have both direct and indirect effects of physiological, psychological, and interpersonal factors that can negatively impact the health and well-being of cancer survivors including sexual and reproductive function and satisfaction. CONCLUSIONS: Cancer, its management, and the resulting late effects must be explored and understood by providers caring for childhood cancer survivors so that educational, psychological, pharmacologic, as well as preventive interventions can be implemented with this population.


Subject(s)
Neoplasms/rehabilitation , Reproductive Health , Sexuality , Adult , Child , Fertility Preservation , Humans , Mental Disorders/etiology , Mental Disorders/prevention & control , Neoplasms/complications , Neoplasms/psychology , Survivors/psychology
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