A Study of the Feasibility and Acceptability of a Psycho-Educational Cognition Intervention in Adolescents and Young Adults (AYAs) With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Enrollment of eligible participants (accrual)
研究概览
简要总结
This pilot trial studies how well a psycho-educational program called Emerging from the Haze works in helping patients with blood and lymph cancer. Sometimes, patients who have undergone treatment for cancer experience thinking or memory problems that make work, school, or everyday life activities, such as grocery shopping, difficult. The Emerging from the Haze program may provide resources to help deal with these types of challenges in patients with blood and lymph cancer.
详细描述
PRIMARY OBJECTIVES:
I. Demonstrate feasibility and acceptability for young adult survivors of various cancers utilizing Emerging from the Haze program.
SECONDARY OBJECTIVES:
I. Describe, summarize study population. II. Characterize, compare the measure scores at pre-intervention assessment to the measure scores at post-intervention assessment.
OUTLINE:
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 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of a hematological malignancy.
- •Having received chemotherapy with or without radiation therapy.
- •Physician approval.
- •Functional Assessment of Cancer Therapy-Cognition (FACT-COG) score < 59 on the perceived cognitive impairments (PCI) subscale.
- •Eligible after 2 months (60 +/- 5 days) of completing all their active cancer treatment with the exception of patients that are post-transplant.
- •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 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 speaking patients.
研究组 & 干预措施
Supportive Care (psycho-educational sessions)
Patients participate in a psycho-educational program weekly over 2 hours for 6 weeks.
干预措施: Educational Intervention (Other)
Supportive Care (psycho-educational sessions)
Patients participate in a psycho-educational program weekly over 2 hours for 6 weeks.
干预措施: Quality-of-Life Assessment (Other)
Supportive Care (psycho-educational sessions)
Patients participate in a psycho-educational program weekly over 2 hours for 6 weeks.
干预措施: Survey Administration (Other)
结局指标
主要结局
Enrollment of eligible participants (accrual)
时间窗: Up to 30 days post the end of the six-week program
Feasibility will be assessed through enrollment of \>= 60% of eligible participants (accrual) and completion of at least 5 out of 6 sessions for \>= 80% of participants (adherence/engagement).
Completion of sessions (adherence/engagement)
时间窗: Up to 30 days post the end of the six-week program
Feasibility will be assessed through enrollment of \>= 60% of eligible participants (accrual) and completion of at least 5 out of 6 sessions for \>= 80% of participants (adherence/engagement).
次要结局
- Change in Functional Assessment of Cancer Therapy-Cognition scores(Baseline up to 30 days post the end of the six-week program)
- Change in Patient Reported Outcomes Measurement Information System (PROMIS) scores(Baseline up to 30 days post the end of the six-week program)
- Change in Global Self-Report of Cognition scores(Baseline up to 30 days post the end of the six-week program)
- Satisfaction Survey scores(Up to 30 days post the end of the six-week program)
- Change in PROMIS-29 items (29) scores(Baseline up to 30 days post the end of the six-week program)