Emerging From the Haze™-A Multi-center, Randomized Controlled Trial to Measure Impact of a Multi-dimensional Psycho-educational Program on Subjective Cognitive Complaints After Breast Cancer Treatment Using Virtual Technology
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- quantify the impact of Emerging from the Haze on breast cancer survivors' self-report of cognitive changes, based on change of the FACT-Cog- perceived cognitive impairment score from baseline to the end of the Haze series compared to the control group.
研究概览
简要总结
At Cedars-Sinai Medical Center, we 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 hours for 6 weeks. The leading neuropsychologist covers material such as guided relaxation, behavioral strategies for automatic/negative thoughts, compensatory strategies for attention and memory, executive functioning, pacing, and balance. Each Haze series will be electronically delivered in a live format to our satellite site, The University of Kansas.
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
- Single (Investigator)
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
- •Completed treatment for stage 1-3 breast cancer at least two months but not more than 24 months prior to enrollment.
- •Having received chemotherapy with or without radiation therapy
- •Female, Age ≥18 years.
- •FACT-Cog score less than 59 on the Perceived Cognitive Impairment subscale
- •Eligible after 2 months of completing all their active cancer treatment with the exception of long-term hormonal treatments or trastuzumab.
- •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
Intervention
Participants in the intervention group will undergo 6 weeks of psycho-educational classes provided in a live setting at Cedars Sinai and a web based setting at The University of Kansas. Each class will focus on a different realm of coping with chemo-brain.
干预措施: Emerging from the Haze (Other)
Waitlist
Participants assigned to the control group will be placed on a wait list for the Haze program. While they are waiting for admittance to the program, they will receive the same surveys as the participants who are taking the Haze class. Additionally, participants assigned to the control group will receive the surveys again when taking the class in order to allow comparison of the effects of the program on the control group. Participants assigned to the wait list will be enrolled in the following Haze series.
干预措施: Emerging from the Haze (Other)
结局指标
主要结局
quantify the impact of Emerging from the Haze on breast cancer survivors' self-report of cognitive changes, based on change of the FACT-Cog- perceived cognitive impairment score from baseline to the end of the Haze series compared to the control group.
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
Arash Asher, MD
Director, Cancer Survivorship and Rehabilitation Samuel Oschin Comprehensive Cancer Institute Cedars-Sinai Medical Center
Cedars-Sinai Medical Center