MANAGING UNCERTAINTY IN ADVANCED PROSTATE CANCER

管理晚期前列腺癌的不确定性

• 批准号: 2883508
• 负责人: MERLE H MISHEL
• 金额: $ 62.59万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 依托单位国家: 美国
• 财政年份: 1993
• 资助国家: 美国
• 起止时间: 1993-09-30 至 2002-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/2883508
• 关键词: African American; cancer rehabilitation /care; caregivers; caucasian American; clinical research; emotional adjustment; health care cost /financing; human subject; mood disorders; neoplasm /cancer education; nursing care evaluation; nursing intervention; oncology nursing; prostate neoplasms; psychological aspect of cancer; quality of life; questionnaires; racial /ethnic difference; therapy compliance

DESCRIPTION (Adapted from the Investigator's Abstract): The proposed study extends a nursing intervention successful in managing uncertainty in men with localized prostate cancer. This study will test a modified version of the intervention with Caucasian and African-American men with advanced prostate cancer, which has a more difficult, complex and fluctuating trajectory than localized prostate cancer. Two approaches for the delivery of the intervention will be tested: treatment to the patient only (treatment direct) or treatment to the patient and his primary support person (treatment supplemented). The investigation will determine the usefulness of the intervention when applied to complex problems of men with advanced prostate cancer when cure is not possible and quality of life is the key outcome variable. Treatment for advanced prostate cancer has a myriad of side-effects including loss of libido, impotence, feminization, incontinence, and pain from metastases. The main hypothesis is that Caucasian and African-American men with advanced prostate cancer who receive the Uncertainty Management Intervention will have significantly less uncertainty, better uncertainty management, better symptom control, and better quality of life than a control group receiving usual care. We will also explore the relative effectiveness of treatment direct and treatment supplemented and the possible interaction of the intervention with ethnicity for all major outcome variables; determine who benefits most from the intervention; identify the most effective components of the intervention; and determine the costs of delivering the intervention in standard practice. The design is a 3 X 2 randomized block, repeated measures design with 3 levels of the intervention (treatment direct, treatment supplemented, and the control condition) crossed with 2 levels of ethnicity (Caucasian and African-American). Subjects will include 129 Caucasian and 129 African-American men and their primary support persons. Measures will be taken at baseline and 4 and 7 months post baseline. The intervention will run for 8 weeks and be delivered via weekly telephone calls by nurses matched to subjects by gender and ethnicity. Variables include uncertainty; cognitive reframing; problem solving; patient-provider communication; symptom intensity, distress, and management; physical and psychosocial functioning; emotional status; depression; and social support. Multivariate models will be used for analysis. Costs of delivering the intervention in practice will be estimated.

描述（根据调查员的摘要改编）：拟议的研究 扩展护理干预措施成功地管理男性的不确定性 与局部前列腺癌。 这项研究将测试修改版本的 与高加索和非裔美国人的干预 前列腺癌，更加困难，复杂和波动 轨迹比局部前列腺癌。 两种交付方法 干预措施将进行测试：仅对患者进行治疗 （直接治疗）或给患者及其主要支持 人（补充治疗）。 调查将确定 当将干预措施应用于男性的复杂问题时的有用性 当无法治愈时，晚期前列腺癌，生活质量是 关键结果变量。 晚期前列腺癌的治疗 无数的副作用，包括失去性欲，阳ot，女性化， 尿失禁和转移疼痛。 主要假设是 患有晚期前列腺癌的白种人和非裔美国人接受 不确定性管理干预将大大减少 不确定性，更好的不确定性管理，更好的症状控制和 比对照组获得常规护理更好的生活质量。 我们将 还探讨治疗直接和治疗的相对有效性 补充以及干预与种族的可能相互作用 对于所有主要结果变量；确定谁从中受益最大 干涉;确定干预的最有效组成部分； 并确定在标准实践中提供干预的成本。 设计是一个3 x 2随机块，重复测量设计与3 干预水平（直接治疗，补充治疗和 控制条件）与2个种族级别（高加索人和 非裔美国人）。 受试者将包括129个白种人和129个 非裔美国人及其主要支持人员。 措施将是 在基线后4个月和7个月以基线为单位。 干预会 运行8周，并通过每周电话由护士致电 与性别和种族相匹配。 变量包括不确定性； 认知重新构图；解决问题；患者提供沟通； 症状强度，困扰和管理；身体和社会心理 功能；情绪状况；沮丧;和社会支持。 多变量 模型将用于分析。 提供干预的成本 实践将被估算。