ACOSOG Community Clinical Oncology Program (CCOP) Research Base

ACOSOG社区临床肿瘤学计划（CCOP）研究基地

• 批准号: 8311660
• 负责人: HEIDI NELSON
• 金额: $ 147.48万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-03 至 2016-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8311660
• 关键词: Address; Adverse effects; American College of Surgeons Oncology Group; Antineoplastic Protocols; Biochemical; Biological Markers; Biological Markers; Biometry; Cancer Control; Cancer Control Research; Cancer Etiology; Cancer Patient; Caring; Cause of Death; Clinic; Clinical; Clinical Pathways; Clinical Research; Clinical Trials; Clinical Trials Design; Collaborations; Communities; Community Clinical Oncology Program; Community Practice; Conduct Clinical Trials; Continuing Education; Data; Detection; Development; Diagnosis; Disease; Early Diagnosis; Educational workshop; Ensure; Epithelial; Evaluation; Event; Fatigue; Film; Goals; Group Affiliation; Guidelines; Impairment; Individual; Inflammation; Intervention; Lead; Leadership; Learning; Life; Malignant Neoplasms; Malignant neoplasm of esophagus; Malignant neoplasm of lung; Malignant neoplasm of pancreas; Medical Errors; Mental Depression; Methodology; Methods; Mission; Molecular; Monitor; National Comprehensive Cancer Network; Oncologic Nursing; Oncology Nurse; Operative Surgical Procedures; Outcome; Outcome Study; Pain; Pathogenesis; Pathology; Patient Care; Patient Outcomes Assessments; Patients; Performance; Personal Satisfaction; Play; Postdoctoral Fellow; Prevention; Prevention Research; Prevention program; Primary Prevention; Principal Investigator; Procedures; Protocols documentation; Provider; Publications; Quality Control; Quality of life; Quality-of-Life Assessment; Radiation therapy; Recovery; Rectal Cancer; Reporting; Research; Research Infrastructure; Research Personnel; Risk; Role; Schedule; Science; Scientist; Screening procedure; Secondary Prevention; Series; Site Visit; Smoker; Smoking; Specimen; Staging; Surgeon; Surgical Oncology; Symptoms; Testing; Toxic effect; Training; Woman; Work; anticancer research; base; burnout; cancer care; cancer prevention; cancer surgery; cancer therapy; cigarette smoking; clinical practice; clinically significant; control trial; disability; experience; high risk; improved; innovation; interest; lung cancer prevention; meetings; member; men; multidisciplinary; novel; oncology; operation; programs; psychosocial; repaired; smoking intervention; statistics; success; treatment trial

DESCRIPTION (provided by applicant): The American College of Surgeons Oncology Group (ACOSOG) is dedicated to improving patient-reported outcomes (PRO) and quality of life (QOL) of the surgical oncology patient through an innovative clinical research program addressing three overarching aims: 1) To incorporate patient-reported outcomes (PRO) into the science of cancer treatment, prevention, and control research; 2) To interact with the clinical trial programs of ACOSOG to develop and test interventions to control side effects and sequelae of locoregional treatments; and, 3) To support individual CCOP groups and affiliated ACOSOG members to accrue patients to ACOSOG treatment trials and CCOP Research Base trials, and, thereby, fulfill the scientific mission of ACOSOG. ACOSOG, through the Mayo Clinic, will serve as a primary CCOP Research Base, producing scientific direction and administrative leadership for both treatment and cancer control trials. The primary goal of the research base is to develop a cancer prevention and control research clinical trials portfolio. The primary scientific aims are: 1) To test whether patient-reported outcomes identifying QOL deficits can lead to interventions that improve cancer patient outcomes; 2) To investigate whether enhancing provider QOL can improve cancer patient care and patient QOL; 3) To investigate biologic markers and test indentations for early detection and prevention of lung cancer. The primary focus of the research base will be investigating the science relating to QOL for surgical oncology trials. Other research base investigational foci are: interventions to control surgical side effects, methodologies, and prevention studies. We at present have 10 CCOPs with ACOSOG affiliations who are dedicated to providing both treatment and cancer control trials. Each of them has pledged to put 12 patients on trial per year so that we are assured of meeting the goal of 50 patients per year on trial. We will also serve as a research base for cancer control and treatment protocol activity of non-CCOP members of ACOSOG. We will cooperate with our affiliated CCOPs and other members in conducting appropriate continuing education and workshops. The research base will provide training and active support for their data managers/research associates and oncology nurses. We will coordinate their multidisciplinary involvement in clinical cancer research protocols. By holding regular meetings of ACOSOG members, we will facilitate the review of ongoing research, plan future research and related professional activities. The research base will construct and maintain quality control procedures and monitor CCOP and member performance not only by timely review of patient accrual, data sheets, pathology material, operative reports, and radiation therapy port films, but also by periodic, randomly scheduled monitoring site visits. The research base will work with investigators and members in preparing publications as well as presentations for national and regional meetings. To accomplish the scientific aims, ACOSOG conducts clinical trials using an infrastructure consisting of five critical components, including: 1) CCOP Research Base Operations and Statistics Center (Rochester MN); 2) CCOP and ACOSOG membership and Networks; 3) ACOSOG Coordinating Center (Durham, NC); 4) Biostatistics (Rochester, MN); and 5) ACOSOG Central Specimen Bank (St Louis, MO). RELEVANCE: The ACOSOG CCOP Research Base will design clinical trials that include the patient views about his or her symptoms and quality of life such as fatigue, pain, and ability to participate in daily activities. The goal of these studies is to improve care of patients who have had cancer surgery or at risk for lung cancer.

描述（由申请人提供）：美国外科医生肿瘤学院（ACOSOG）致力于改善手术肿瘤学患者的患者报告的结果（PRO）和生活质量（PRO）和生活质量（QOL），通过针对三个总体目的的创新临床研究计划：1），以纳入患者报道（Pro）（PRO）（PRO）（PRO）（PRO）（PRO）（PRO）（PRO）（PRO）（PRO）（PRO）（PRO）的科学治疗，并进行癌症治疗，预测，预测，预测，预测，预测，预测，预测，预测，预测; 2）与ACOSOG的临床试验计划相互作用，以开发和测试干预措施，以控制局部区域治疗的副作用和后遗症； 3）支持各个CCOP组和附属ACOSOG成员，以吸引患者参加ACOSOG治疗试验和CCOP研究基础试验，从而履行AcoSOG的科学任务。 Acosog通过Mayo诊所将成为主要CCOP研究基础，为治疗和癌症控制试验提供科学方向和行政领导。研究基础的主要目标是开发预防癌症和控制研究临床试验组合。主要的科学目的是：1）测试患者报告的结果是否鉴定出QOL缺陷的结果是否会导致干预措施，从而改善癌症患者的预后； 2）调查增强提供者QOL是否可以改善癌症患者护理和患者QOL； 3）研究生物学标记和测试凹痕，以提早检测和预防肺癌。研究基础的主要重点是研究与QOL有关​​外科肿瘤学试验的科学。其他研究基础研究重点是：控制手术副作用，方法论和预防研究的干预措施。目前，我们有10个具有ACOSOG隶属关系的CCOP，他们致力于提供治疗和癌症控制试验。他们每个人都承诺每年将12名患者进行试验，以便我们确保每年实现50名患者的审判目标。我们还将作为AcoSOG非CCOP成员的癌症控制和治疗方案活动的研究基础。我们将与附属的CCOPS和其他成员合作进行适当的继续教育和讲习班。研究基础将为其数据经理/研究助理和肿瘤护士提供培训和积极支持。我们将协调他们在临床癌症研究方案中的多学科参与。通过定期举行AcoSOG成员会议，我们将促进正在进行的研究，计划未来的研究和相关专业活动的审查。研究基础将不仅通过及时审查患者应计，数据表，病理材料，手术报告和放射治疗端口膜，而且还通过定期，随机的，随机的监视现场就诊来构建和维护质量控制程序，并监控CCOP和会员绩效。研究基础将与调查人员和成员合作准备出版物以及国家和地区会议的演讲。为了实现科学目的，AcoSOG使用由五个关键组成部分组成的基础设施进行临床试验，包括：1）CCOP研究基础运营与统计中心（Rochester MN）； 2）CCOP和ACOSOG成员和网络； 3）Acosog协调中心（北卡罗来纳州达勒姆）； 4）生物统计学（明尼苏达州罗切斯特）； 5）Acosog中央标本库（密苏里州圣路易斯）。 相关性：ACOSOG CCOP研究基础将设计临床试验，其中包括患者对其症状和生活质量（例如疲劳，疼痛和参与日常活动的能力）的看法。这些研究的目的是改善患有癌症手术或患有肺癌风险的患者的护理。