C-SMART for Patients With Primary Brain Tumors: A Feasibility and Acceptability Pilot of a Novel Neuropsychological Intervention
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Determine feasibility of C-SMART - Data collection procedures
研究概览
简要总结
The goal of Phase Ib Trial is to determine the feasibility and acceptability of telehealth C-SMART for patients with primary brain tumor and mild neurocognitive deficits (N=18) and their caregivers (N=14) A subset (n=3) of participants will undergo rs-fMRI both pre- and post-C-SMART to test feasibility of advanced functional imaging in this population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patient Inclusion Criteria:
- •Confirmed primary brain tumor diagnosis by histology or neuro-oncologist review of imaging
- •At least one domain of neurocognitive function >1.5 SD below the average or the individual's estimated premorbid functioning, using the expanded ICCTF clinical trials battery and Test of Premorbid Functioning for comparison
- •>1 month post brain surgery and/or radiation therapy, if applicable
- •Estimated premorbid intelligence >
- •Patients must be age 18+ and primarily English speaking
排除标准
- •Presence of major neurocognitive impairment that would prevent participation in the intervention, and/or severe aphasia, and/or inability to understand and provide informed consent
- •Inability to attend weekly telehealth appointments; based on EAB results
- •Clinically significant insomnia symptoms
- •< 1 month post brain surgery and/or radiation therapy
- •Unstable internet connection or an inability to work teleconferencing software. Participants will be supplied an iPad if they do not have an adequate device.
- •To participate in the fMRI portion of this study participants cannot have any metal in their bodies. For the fMRI subset, participants cannot have metal in their body as the MRI scan could cause them harm and if female of childbearing years, they cannot be pregnant as the MRI scan may pose risk to the unborn fetus.
- •Caregiver Inclusion Criteria
- •Must be an adult caregiver of an enrolled patient (see criteria above)
- •Primarily English speaking
- •Caregiver Exclusion Criteria
- •1. Paid caregiver (e.g. home health aide)
研究组 & 干预措施
Patient
C-SMART intervention will be provided via telehealth. Participants will complete in-person neurocognitive testing (baseline, post-intervention) as well as surveys (baseline, post-session, post-intervention) via secure email link. Exit interviews will be conducted by Zoom.
干预措施: C-SMART (Behavioral)
Caregiver
Informal caregiver that may enroll with the patient (not required)
干预措施: C-SMART (Behavioral)
结局指标
主要结局
Determine feasibility of C-SMART - Data collection procedures
时间窗: 10 months
As evidenced by the number of participants that complete the neurocognitive assessments pre- and post-intervention
Determine feasibility of C-SMART recruitment
时间窗: 10 months
As evidenced by rates of participant screening, eligibility, and consent
Determine feasibility of C-SMART - Retention Rate
时间窗: 11 months
As evidenced by the number of patients that complete post-intervention measures
Determine acceptability of C-SMART intervention - Satisfaction
时间窗: 10 months
After each intervention session, participants will be sent a link for a brief post-session satisfaction survey via secure email link. In this survey, participants will rate 1) topic applicability; 2) perceived benefit of session; 3) comfort with interventionist(s); 4) overall satisfaction and 5) likelihood of recommending the program to others. Responses are ranked on a Likert-type scale from 1 being "Not at all" to 5 being "A great deal". Higher scores indicate greater satisfaction with the intervention session.
Determine acceptability of C-SMART intervention - Satisfaction - Recommendation
时间窗: 10 months
As evidenced by the number of patients that would recommend the intervention to others
Optimization of C-SMART research procedures
时间窗: 8 months
The number of participants that complete exit interviews will be audio recorded and transcribed verbatim. The PI and a second independent coder will separately review each transcript to identify common themes and develop a coding framework of free responses. All results will be reviewed for agreement and comparison to the raw data, and discrepancies will be resolved through discussion with the PI until reliability is reached (Kappa\>.80)
Determine preliminary feasibility of longitudinal rs-fMRI procedures for a subset of patients
时间窗: 10 months
Completion rate of neuroimaging at post-intervention
次要结局
- Determine feasibility of C-SMART research procedures - Patient reported outcome completion(10 months)