Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Gary Morrow
- 入组人数
- 418
- 试验地点
- 36
- 主要终点
- Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale
研究概览
简要总结
This randomized clinical trial compares multimedia psychoeducation to print education in preparing patients with cancer for decision making about clinical trial participation. Multimedia psychoeducation includes a digital video disc (DVD) and written materials with a combined focus on knowledge and attitude change, and may be an effective method to help patients prepare for decision making about clinical trial participation. It is not yet known whether a multimedia psychoeducation is more effective than print education in preparing patients for decision making about clinical trials.
详细描述
PRIMARY OBJECTIVES:
I. To determine the effect of intervention assignment on patients' preparedness for decision making about clinical trial participation.
SECONDARY OBJECTIVES:
I. To determine the effect of intervention assignment on indicators of the quality of patients' decision making about clinical trial participation.
II. To examine mechanisms by which multimedia psychoeducation (MP) exerts its expected positive effects on preparedness for decision making.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to speak and read English
- •Be diagnosed with cancer
- •Have been informed of their eligibility for a specific phase II or III therapeutic clinical trial open for enrollment at the participating NCI Community Oncology Research Program (NCORP) site
- •Have already met one or more eligibility criteria and have a reasonable expectation of meeting any remaining eligibility criteria for the therapeutic clinical trial
- •Be capable of providing written informed consent for study participation
排除标准
- •Participants must not have been asked previously to participate in another therapeutic cancer clinical trial
- •Participants must not have already made a decision to participate in the phase II or III therapeutic clinical trial for which they were informed of their eligibility
- •Participants must not have documented or observable visual, auditory, psychiatric, or neurological disorders that would interfere with study participation (e.g., blindness, deafness, psychosis, or dementia)
- •Participants must not be eligible only for phase I trial; these patients are excluded because few of these trials are offered at NCORP sites and because their design and goals differ considerably from those of phase II and III trials
结局指标
主要结局
Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale
时间窗: Day 3 to 7
Preparation for Decision Making Scale (PDMS) is a valid and reliable 10-item self-report measure for which respondents rate the usefulness of materials they were provided in preparing them to communicate with their health care provider and make a health care decision. Each item is scored 1 to 5 where 1=Not at All, 2=A Little, 3=Somewhat, 4=Quite a Bit, 5=A Great Deal. Larger number is better. All 10 scores are summed, then divided by 10; The result - 1 is then multiplied by 25 and we have a range from 0 (less prepared) - 100 (most prepared).
次要结局
- The Decisional Conflict Scale (DCS)(Day 49-56)
- The Decision Regret Scale (DRS)(Day 49-56)