A Pilot Study of Emerging From the Haze Evaluating a Trainee-taught Psycho-educational Program to Improve Cancer-related Cognitive Complaints in Gynecologic Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- The Functional Assessment of Cancer Therapy- Cognition (FACT-Cog) Survey
研究概览
简要总结
At Cedars-Sinai Medical Center, the investigators have developed a novel curriculum for a 6-week psycho-educationally-based, cognitive behavioral program to help patients with subjective cognitive complaints after cancer treatment, titled Emerging from the Haze™ (Haze). Each series meets once a week for 2-2.5 hours for 6 weeks.
The objective of this study is to quantify the impact of a trainee-taught Emerging from the Haze course on gynecologic cancer survivors' self-report of cognitive changes based on the change of FACT-Cog score.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of any stage gynecologic cancer including ovarian, uterine/endometrial, cervical, vulvar, and vaginal cancer
- •Treated with chemotherapy solely or in combination with surgery, radiation, and/or hormonal therapy
- •Female, age ≥ 18 years.
- •FACT-Cog score < 59 on the PCI sub scale
- •Eligible after 2 months (60 ±5 days) of completing all their active cancer treatment with the exception of long-term hormonal treatments
- •Subjective complaint of cognitive concerns at time of enrollment
- •Must be able to understand and communicate proficiently in English
- •Ability to understand and the willingness to sign a written informed consent.
- •Agree to complete study surveys
排除标准
- •Patients who have significant personality disorders or unstable psychiatric disorders (including active major depression, substance abuse, psychosis or bipolar disorder) as assessed by the interviewing clinician
- •Patients with known brain metastases, history of brain metastases or radiation to the brain.
- •Patients with a history of stroke or other pre-existing neurological condition that may contribute to cognitive dysfunction.
- •Non-English speakers
- •Receiving treatment for another malignancy other than breast cancer
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, chronic anemia, uncontrolled hypothyroidism, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
研究组 & 干预措施
Emerging from the Haze class
A 6-week psycho-educationally-based, cognitive behavioral program to help patients with subjective cognitive complaints after cancer treatment, titled Emerging from the Haze™ (Haze). Each series meets once a week for 2-2.5 hours for 6 weeks.
干预措施: Emerging from the Haze class (Behavioral)
结局指标
主要结局
The Functional Assessment of Cancer Therapy- Cognition (FACT-Cog) Survey
时间窗: First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class
Measure the change in score from baseline to each of three time points: last day of class (6 weeks), 6 months, and 1 year after class
次要结局
- Patient Reported Outcomes Measurement Information System (PROMIS) - Cognition and General Concerns Survey(First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class)
- UCLA Loneliness Scale Survey(First day of class (baseline), last day of class (6 weeks), 6 months and 1 year after class)
研究者
Arash Asher, MD
Director of Cancer Rehabilitation and Survivorship
Cedars-Sinai Medical Center