Biobehavioral Correlates of Cancer-related Cognitive Dysfunction and Its Co-occurring Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 682
- 试验地点
- 1
- 主要终点
- Subjective Cognitive Dysfunction
研究概览
简要总结
This descriptive, cross-sectional study will evaulate and fully characterize factors associated with cognitive dysfunction in Breast Cancer (BCS) and Colorectal Cancer (CRC) survivors that have cognitive concerns, and factors associated with psychoneurological symptom cluster in BCS and CRC survivors.
详细描述
Primary Aim: To identify demographic factors (age and education), medical and cancer treatment-related factors (comorbidities and treatment type), psychosocial factors (perceived stress, affect, optimism, coping, emotional support), cancer-related symptoms (pain, depression, anxiety, fatigue and sleep disturbance), and genetic factors (APOE, COMT, BDNF) associated with the level of subjective or the level of objective cognitive dysfunction in breast cancer and colorectal cancer survivors.
Secondary Aim: To identify demographic factors (age and education), medical and cancer treatment-related factors (comorbidities and treatment type), psychosocial factors (perceived stress, affect, optimism, coping, emotional support), and genetic factors (APOE, COMT, BDNF) associated with psychoneurological symptom cluster using either subjective or objective cognitive dysfunction in breast cancer and colorectal cancer survivors.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria for Breast cancer survivors:
- •≥ 21 years of age and older
- •Ability to provide written consent and HIPAA authorization
- •≥6 months post-adjuvant therapy and neo-adjuvant therapy for early stage (Stage I-IIIA) breast cancer.
- •Current Aromatase Inhibitors or Tamoxifen treatment at time of enrollment is allowed.
- •Identify cognitive concerns (select yes)
- •Inclusion Criteria for Colorectal cancer survivors:
- •Male or female CRC survivors
- •Ability to provide written consent and HIPAA authorization
- •≥ 21 years of age and older
- •≥6 months post-adjuvant therapy and neo-adjuvant therapy for early stage (stage I-III) CRC
- •Identify cognitive concerns (select yes)
排除标准
- •Report metastatic breast or colorectal cancer (Stage IV) at time of consenting.
- •Unable to read and understand English to complete survey questionnaires.
结局指标
主要结局
Subjective Cognitive Dysfunction
时间窗: greater than or equal to 6 months post cancer treatment
PROMIS - Cognitive Abilities and Concerns
次要结局
- Objective Cognitive Dysfunction(greater than or equal to 6 months post cancer treatment)
研究者
Diane Von Ah
Associate Dean of Academic Operations
Indiana University