NCT00830635已完成不适用
Cancer Information Service Research Consortium: Years 2006-2011 Program Narrative and Overview
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,800
- 试验地点
- 5
- 主要终点
- Physical functioning
研究概览
简要总结
RATIONALE: A multimedia educational program may help patients with newly diagnosed prostate cancer and breast cancer reduce distress, make informed treatment decisions, and improve quality of life.
PURPOSE: This randomized clinical trial is studying how well a multimedia educational program works in patients with early-stage prostate cancer or breast cancer.
详细描述
OBJECTIVES:
Primary
- Determine whether an innovative multimedia educational program will help newly diagnosed prostate (project 1) and breast (project 2) cancer patients prepare for their journey as cancer patients, promote informed treatment decision-making and reduce cancer-specific distress, and among breast cancer patients at re-entry, facilitate an informed re-entry transition to cancer survivorship and reduce cancer-specific distress (project 3).
- Determine whether having Cancer Information Service (CIS) Information Specialists make a scheduled telephone callback to callers in project 3 will augment and support use of the CIS Research Consortium (CISRC) multimedia educational programs and further enhance the study outcomes examined in this program of research.
- Determine whether the hypothesized mediational variables account for significant intervention effects in each of the three component projects.
- Examine potential moderator variables to assess potential differences in intervention efficacy by selected subgroups (e.g., age, education) within each component project.
- Conduct an in-depth tracking study of utilization patterns for a detailed description of different patterns of use, as well as elucidating those components or modules within the program that had differential utilization by participants.
- Assist the CIS and other similar cancer information systems in disseminating one or more of the CISRC interventions should they prove effective in this program of research.
Secondary
- Conduct secondary analyses across projects (i.e., perceived need for and benefit from the CISRC interventions and intervention efficacy across three high priority cancer patient populations) that will be made possible by the use of a common theoretical framework, the same or similar intervention and research design across projects, and a common set of endpoints.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Physical functioning
Benefit-finding
Decisional conflict (projects 1 and 2)
Interpersonal functioning
Cancer-specific distress
Emotional quality of life
Regret (projects 1 and 2)
Fear of recurrence (project 3)
Practical concerns (project 3)
次要结局
未报告次要终点
研究者
研究点 (5)
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