Modifying Memory and Attention Adaptation Training (MAAT) For Young Adult Childhood Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 3
- 主要终点
- CNS Vital Signs (CNSVS) Online Neuropsychological Test Battery (3) Stroop Test (ST) (visual motor reaction time, processing speed and visual discrimination)
研究概览
简要总结
The goal of this clinical trial is to pilot-test a modified version of telehealth-delivered Memory and Attention Adaption Training (MAAT) that is tailored to young adult childhood cancer survivors (ages 18-39; MAAT-YS) with cancer-related cognitive impairment (CRCI). MAAT-YS consists of 8 weekly visits (45-minutes in duration) and participants use a survivor workbook and complete homework between visits. Participants in this single-group pilot trial (N=9) will complete online self-report measures of cognitive symptoms, quality of life, treatment satisfaction and a brief online neuropsychological test battery at baseline and post-MAAT-YS timepoints.
详细描述
The goal of this clinical trial is to pilot-test a modified version of telehealth-delivered Memory and Attention Adaption Training (MAAT) that is tailored to young adult childhood cancer survivors (ages 18-39; MAAT-YS) with cancer-related cognitive impairment (CRCI). MAAT-YS consists of 8 weekly visits (45-minutes in duration) and participants use a survivor workbook and complete homework between visits.
This pilot trial will determine MAAT-YS feasibility, treatment satisfaction and size of effect in self-report and objective measures of neurocognitive function.
Eligible participants will be 9 individuals who were diagnosed with non-central-nervous system (CNS) cancer (including leukemia/lymphoma without known CNS involvement) prior to the age of 18, are at least 1-year from completion of cancer treatment, including chemotherapy.
Participants will complete online self-report measures of cognitive symptoms, quality of life, treatment satisfaction and a brief online neuropsychological test battery at baseline and post-MAAT-YS timepoints.
If successful, further research is planned with a larger, multi-site randomized controlled trial of MAAT-YS.
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 39 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-39
- •Diagnosed prior to 18 years of age with non-CNS solid tumor or leukemia/lymphoma without known CNS involvement
- •At least 1 year after completion of treatment including chemotherapy, cancer-free
- •English fluent
- •Memory or other cognitive problems attributed to cancer and/or cancer treatment
- •Score of <10 on the FACT-Cog Impact on Quality of Life Scale
- •Willing to use telehealth with internet access
- •Willing to provide informed consent to participation
排除标准
- •Severe non-cancer brain injury such as severe traumatic brain injury, stroke or toxic injury causing memory impairments;
- •Currently meeting Diagnostic and Statistical Manual-5 (DSM-5) criteria for a severe psychiatric disorder, including substance abuse, mood, anxiety, or psychotic disorders, as assessed by the PRIME-MD;
- •Scoring 3 or below on the 6-item cognitive screen designed to detect severe memory disorders;59
- •Severe uncorrected sensory impairment (severe hearing or visual impairment).
研究组 & 干预措施
MAAT-YS Group
This group will be treated with the MAAT-YS cognitive-behavioral therapy.
干预措施: MAAT-YS (Behavioral)
结局指标
主要结局
CNS Vital Signs (CNSVS) Online Neuropsychological Test Battery (3) Stroop Test (ST) (visual motor reaction time, processing speed and visual discrimination)
时间窗: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
CNSVS Stroop Test (ST) is a computer-based neuropsychological test of visual motor reaction time, processing speed and visual discrimination. The test is measured in standard score units (Mean of 100; SD 15). Higher scores denote better cognitive function.
CNS Vital Signs (CNSVS) Online Neuropsychological Test Battery (1) Verbal Memory (VBM) (recognition memory for words)
时间窗: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
CNSVS Verbal Memory (VBM) is a computer-based neuropsychological test of word recognition and memory for words). The test is measured in standard score units (Mean of 100; SD 15). Higher scores denote better cognitive function.
CNS Vital Signs (CNSVS) Online Neuropsychological Test Battery (4) 4-Part Continuous Performance Test (FPCPT) (sustained attention and working memory)
时间窗: Baseline to Post-Treatment (after 8 weekly telehealth MAAT visits)
CNSVS 4-Part Continuous Performance Test (FPCPT) is a computer-based neuropsychological test of sustained attention and working memory. The test is measured in standard score units (Mean of 100; SD 15). Higher scores denote better cognitive function.
Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) v.3. Perceived Cognitive Impairments Scale (PCI)
时间窗: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
The PCI assesses perceived cognitive function of participants within a timeframe of the previous 7 days. It consists of 18 items with a 5-point Likert-type rating of 0 (Never) to 4 (Several times a day) with a scoring range of 0-72. Scoring instructions indicate items are reverse scored, such that higher scores denote better perceived cognitive function, lower scores, poorer cognitive function.
CNS Vital Signs (CNSVS) Online Neuropsychological Test Battery (2) Symbol Digit Coding (SDC) (visual motor processing speed)
时间窗: Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits)
CNSVS Symbol Digit Coding (SDC) is a computer-based neuropsychological test of visual motor processing speed. The test is measured in standard score units (Mean of 100; SD 15). Higher scores denote better cognitive function.
次要结局
- Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2. Global Health - Mental 2a(Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits))
- Functional Assessment of Cancer Therapy-Cognitive (FACT-Cog) v.3. Impact on Quality-of-Life Scale (IQOL)(Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits))
- Metamemory in Adulthood-Anxiety Scale (MIA-A)(Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits))
- Patient-Reported Outcomes Measurement Information System (PROMIS) Depression v.1. - Short Form 4a(Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits))
- Credibility/Expectancy Questionnaire (CEQ)(Only administered after Visit 6 of MAAT-YS (after 6 weeks))
- Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue v.1. - Short Form 4a(Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits))
- Cognitive-Symptom-Checklist-Work-21 (CSC-W-21)(Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits))
- Treatment Satisfaction Questionnaire (TSS)(Post-MAAT-YS treatment only (8 weeks))
- Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety v.1. - Short Form 4a(Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits))
- Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2. Global Health - Physical 2a(Baseline to Post-Treatment (after 8 weekly telehealth MAAT-YS visits))
研究者
Donna Posluszny
Associate Professor
University of Pittsburgh