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会 (ACOSOG) 致力于通过创新的临床研究计划来改善肿瘤外科患者的患者报告结果 (PRO) 和生活质量 (QOL)，该项目旨在解决三个总体目标： 1) 将患者报告结果（PRO）纳入癌症治疗、预防和控制研究的科学中； 2) 与 ACOSOG 的临床试验项目互动，开发和测试控制局部治疗副作用和后遗症的干预措施； 3) 支持各个 CCOP 团体和附属 ACOSOG 成员招募患者参加 ACOSOG 治疗试验和 CCOP 研究基地试验，从而履行 ACOSOG 的科学使命。 ACOSOG 通过梅奥诊所，将作为主要的 CCOP 研究基地，为治疗和癌症控制试验提供科学指导和行政领导。该研究基地的主要目标是开发癌症预防和控制研究临床试验组合。主要科学目标是： 1) 测试患者报告的生活质量缺陷结果是否可以导致改善癌症患者预后的干预措施； 2) 调查提高提供者的生活质量是否可以改善癌症患者的护理和患者的生活质量； 3) 研究肺癌早期发现和预防的生物标志物和测试压痕。该研究基地的主要重点将是调查与肿瘤外科试验的生活质量相关的科学。其他研究基础研究重点是：控制手术副作用的干预措施、方法和预防研究。目前，我们有 10 名隶属于 ACOSOG 的 CCOP，致力于提供治疗和癌症控制试验。他们每个人都承诺每年试验12名患者，这样我们就有信心实现每年试验50名患者的目标。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地。我们将与附属 CCOP 和其他成员合作开展适当的继续教育和研讨会。该研究基地将为数据管理员/研究助理和肿瘤护士提供培训和积极支持。我们将协调他们对临床癌症研究方案的多学科参与。通过定期召开 ACOSOG 成员会议，我们将促进对正在进行的研究的审查，规划未来的研究和相关专业活动。研究基地将建立和维护质量控制程序，并通过及时审查患者应计情况、数据表、病理材料、手术报告和放射治疗端口胶片，以及定期、随机安排的监测现场访问来监测 CCOP 和成员的表现。该研究基地将与研究人员和成员合作准备出版物以及国家和地区会议的演示文稿。为了实现科学目标，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 研究基地运营和统计中心（明尼苏达州罗切斯特）； 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 中央样本库（密苏里州圣路易斯）。 相关性：ACOSOG CCOP 研究基地将设计临床试验，其中包括患者对其症状和生活质量（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对接受过癌症手术或有患肺癌风险的患者的护理。