Promoting Adjustment in Uveal Melanoma Survivorship: A Randomized Trial Targeting Illness Perceptions
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Change in illness perceptions of chronicity
研究概览
简要总结
This clinical trial evaluates a video-based psychoeducational intervention for patients with uveal melanoma. Uveal melanoma (UM) is a rare intraocular cancer. UM patients face an uncertain course of survivorship in terms of their visual acuity, treatment-related side effects, and risk for eventual metastasis of the cancer. Learning about patients' thoughts and reactions to informational resources may better support patients during ocular melanoma survivorship.
详细描述
PRIMARY OBJECTIVE:
I. To assess the efficacy of the psychoeducation intervention (compared to the control condition) in modifying illness perceptions of disease control, chronicity, and coherence (i.e., to become less threatening) over the course of the follow-up period.
SECONDARY OBJECTIVE:
I. To assess the efficacy of the psychoeducation intervention (compared to the control condition) in reducing the degree of participant's depressive and anxiety symptoms over the course of the follow-up period.
OUTLINE: Participants are randomized to 1 of 2 arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Adults (age 18 years and older at visit 1)
- •History of uveal melanoma as documented in their University of California, Los Angeles (UCLA) medical record
- •Receipt of uveal melanoma treatment and/or ongoing follow-up care at the UCLA Jules Stein Eye Institute, as documented in their UCLA medical record
- •Ability to read, write, and converse in English
- •Access to the internet via a computer or cell phone
- •Access to a personal email address
- •Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
排除标准
- 未提供
研究组 & 干预措施
Arm 1
Participants watch two fifteen-minute educational videos and receive a mental health resource information sheet on study.
干预措施: Education for Intervention (Behavioral)
Arm II
Patients receive enhanced treatment as usual and receive a mental health resource information sheet on study.
干预措施: Best Practice (Behavioral)
结局指标
主要结局
Change in illness perceptions of chronicity
时间窗: From baseline to day 77
Will be assessed using the BIPQ will be examined across treatment and control conditions using multilevel models.
Change in illness perceptions of disease control
时间窗: From baseline to day 77
Will be assessed using the Brief Illness Perception Questionnaire (BIPQ) and will be examined across treatment and control conditions using multilevel models.
Change in illness perceptions of coherence
时间窗: From baseline to day 77
Will be assessed using the BIPQ will be examined across treatment and control conditions using multilevel models.
次要结局
- Domains of mental health: Depression(From baseline to day 77)
- Domains of mental health: Anxiety(From baseline to day 77)