Cognitive Remediation Therapy (CRT) for Adults Treated for Cancer: A Single-arm Proof of Concept Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Self-report of daily cognitive function
研究概览
简要总结
This study is to determine the safety, feasibility and acceptability of an 8-week cognitive remediation training (CRT) in patients treated for cancer. The secondary objective of the study is to estimate the effect size of CRT in improving neurocognitive functioning and quality of life. This is a single-arm proof of concept study. Patients treated for cancer with persistent cognitive complaints will be recruited from the outpatient clinic of the VA Comprehensive Cancer Center, West Haven, CT, Yale Medicine, and greater New Haven community.The active treatment phase will be followed by an assessment at the conclusion of treatment to evaluate changes in cognitive function and quality of life. Participants will be invited back to participate in a final follow-up assessment 2 months later.
详细描述
Objectives:
The primary objective of this study is to determine the safety, feasibility and acceptability of an 8-week cognitive training intervention in patients treated for cancer. The secondary objective of the study is to estimate the effect size of CRT in improving neurocognitive functioning and quality of life for three different populations of cancer patients.
Research Design:
This is a single-arm proof of concept study with three cancer groups. Patients treated for cancer with persistent cognitive complaints will be recruited from the outpatient clinic of the VA Comprehensive Cancer Center, West Haven, CT, Yale Medicine, and greater New Haven community. We intend to enroll approximately 30 participants, with approximately 10 from each of the following cancer treatment types (1) participants who are at least six months from completion of adjuvant chemotherapy or chemoradiation and are in remission; (2) participants who are receiving long-term chemotherapy (6 months or longer) with a diagnosis of Stage IV cancer and with stable medical condition; (3) participants who are receiving long-term (6 months or longer) hormone therapy (androgen deprivation therapy or anti-estrogen therapy). Patients in this group who received chemotherapy will be eligible if they completed chemotherapy at least 6 months prior to enrolling. There will be an eight-week intervention period and a two-month follow-up assessment.
Methodology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •1.Participants who:
- •are at least six months from completion of adjuvant chemotherapy or chemoradiation and are in remission or;
- •are receiving long-term chemotherapy (6 months or longer) with a diagnosis of Stage IV cancer and with stable medical conditions or;
- •are receiving long-term (6 months or longer) hormone therapy (androgen deprivation therapy or anti-estrogen therapy). Patients in this group who received chemotherapy will be eligible if they completed chemotherapy at least 6 months prior to enrolling.
- •Subjective reports of cognitive decline.
- •Report that they are interested in seeking treatment to address their cognitive concerns.
- •Age 18 or older.
- •Fluency in English and a 6th grade or higher reading level.
排除标准
- •Does not meet one of the three participant categories
- •Unstable medical condition.
- •History of, or current symptoms of, serious psychiatric disorder requiring antipsychotic medications or hospitalization.
- •Current substance abuse disorder.
- •History of, or current central nervous system (CNS) malignancies, CNS radiation, intrathecal chemotherapy, or CNS-involved surgery.
- •Current IQ estimate less than
- •Unable to give written informed consent.
研究组 & 干预措施
Cognitive Remediation Therapy
Cognitive Remediation Training is comprised of 8 weeks of active cognitive training using Brain HQ auditory and visual training tasks. Training is twice per week for up to 2 hours. Also included is a Bridging Group at each training session. The Bridging group provides information about cognitive training and compensatory strategies to generalize the benefits of training to daily life.
干预措施: Cognitive Remediation Therapy (Behavioral)
结局指标
主要结局
Self-report of daily cognitive function
时间窗: 8 weeks
Self-reported cognitive function includes symptoms of perceived cognitive impairments, perceived cognitive abilities, and overall quality of life. These are aggregated into a classification of overall degree of impairment and disability
次要结局
- Neurocognitive function(8 weeks)