A Nurse-Led Intervention for Fear of Progression in Advanced Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Feasibility of recruitment
研究概览
简要总结
This clinical trial focuses on a nurse-led program that is designed to help patients cope with worries, fears, and uncertainty about the future. The purpose of this study is to understand if the program is helpful and practical to carry out at medical centers and community clinics. This study may help patients learn more effective ways to cope and respond to your concerns and any unhelpful thoughts.
详细描述
PRIMARY OBJECTIVES:
I. To assess the feasibility and acceptability of the revised day by day (DBD) intervention in an academic and community settings.
II. To assess the preliminary effects of the revised DBD intervention for reducing fear of progression (FOP) and improving distress, anxiety, depression, metacognitions (beliefs about worry), and mindfulness.
OUTLINE:
Patients participate in 5 videoconference sessions over 30 minutes each over 6 weeks focused on worry management skills, values-based goal setting, and brief mindfulness-based practices, then complete patient workbook activities after each session over 15-20 minutes per day. Patients also complete a survey over 8 minutes at 6 weeks, an exit interview at 7 weeks, and questionnaires over 25 minutes each at baseline, 6 weeks, and 10 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with stage III or IV gynecologic (GYN) or lung cancer
- •At least 3 months from initial diagnosis
- •Score >= 34 on the Fear of Progression-short form (SF) questionnaire
排除标准
- •Severe mental illness (e.g. psychosis)
- •Hospice enrolled
- •Non-English speaking
研究组 & 干预措施
Supportive care (videoconference, questionnaire, survey)
Patients participate in 5 videoconference sessions over 30 minutes each over 6 weeks focused on worry management skills, values-based goal setting, and brief mindfulness-based practices, then complete patient workbook activities after each session over 15-20 minutes per day. Patients also complete a survey over 8 minutes at 6 weeks, an exit interview at 7 weeks, and questionnaires over 25 minutes each at baseline, 6 weeks, and 10 weeks.
干预措施: Educational Intervention (Other)
结局指标
主要结局
Feasibility of recruitment
时间窗: Up to 10 weeks
Defined by enrollment rate. Enrollment rate will be calculated as number of enrolled divided by the number of eligible patients.
Feasibility of the intervention
时间窗: Up to 10 weeks
Defined by attrition, attendance, and adherence with home practice activities. Attrition rate will be calculated as number of patients who drop out patients divided by number of enrolled patients. Adherence will be assessed based on the completion rate of home practice activities.
Acceptability
时间窗: Up to 10 weeks
Will be assessed based on 1) responses to open-ended questions on the exit interview response asking about participants' experience with the intervention and delivery platforms; and 2) a self-report evaluation survey rating usefulness of the session content, home practice activities, testimonials, and delivery platforms. Survey items are rated on a 1-5 Likert scale. An average score of 3 or above will indicate good acceptability.
次要结局
未报告次要终点