A Mindfulness Approach to Scanxiety
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 主要终点
- Likert-Style Anxiety Scale
研究概览
简要总结
"Scanxiety" is a term coined to describe anxiety related to imaging during cancer treatment and has not been robustly studied in pediatric oncology caregivers. Mindfulness-based Stress Reduction (MBSR) is a meditation-based program that offers a non-pharmacologic approach to managing stress. The main purposes of this study are two-fold: 1). to determine if scanxiety exists in the caregivers of pediatric oncology patients and 2.) if scanxiety is found, does the implementation of a mindfulness program help to improve caregiver anxiety related to imaging.
详细描述
"Scanxiety" is a term coined to describe anxiety related to imaging during cancer treatment. It is multifactorial and includes anxiety leading up to the scan as well as the waiting period after imaging and prior to results, as well as worry about possible changes in treatment. It has been documented in adult oncology literature and is associated with lower quality of life. Past adult studies show an inverse relationship with time since diagnosis and scanxiety, the further out from diagnosis, the lower level of scanxiety. Scanxiety is higher in those with lower education levels and higher baseline anxiety. Though scanxiety has been sparsely acknowledged in pediatric oncology literature, anxiety has been documented in parents of pediatric patients receiving MRI's for various diagnoses. Although caregivers of pediatric oncology patients experience high levels of distress, to date there are no studies that have measured the presence of scanxiety specifically in caregivers of pediatric oncology patients. Therefore, there are no intervention studies attempting to ameliorate anxiety related to imaging in the caregivers of pediatric oncology patients.
Mindfulness-based Stress Reduction (MBSR) is a meditation-based program that offers a non-pharmacologic approach to managing stress. Its effects of reducing stress and other stress-related outcomes including anxiety is documented in various populations including police officers, prison inmates, university students, adolescents with cardiac diagnoses, and healthcare professionals. It has also been used to decrease stress in oncology patients and the partners of adult oncology patients. MBSR sessions can be provided in person but are also effective in an online training format. Although it has been well-studied in a variety of populations, the effectiveness of MBSR has yet to be evaluated in the caregivers of pediatric oncology patients. In particular, this study aims to fill the scientific gap in exploring if MSBR may reduce scanxiety in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Able to understand spoken English and be able to read written English
- •18 years of age or older
- •Able to understand and willing to sign informed consent document
- •Have access to a smart phone or tablet device that is able to receive texts
- •Is a caregiver of any age oncology patient (including patients above 18 years of age)
- •Caregiver of a patient that is scheduled for a routine scan (CT's, MRI's, PET scans) within the upcoming 3 months
- •If assigned to the Phase 2 intervention group, willing and able to eat a raisin (a box of which will be mailed to home address)
排除标准
- •Oncology patient is of adult age and caring for self
- •Medically-diagnosed cognitive delay in caregiver (by self-disclosure in eligibility questionnaire)
- •Upcoming scan is due to concern for relapse/disease recurrence and is urgent
- •Upcoming scan is part of initial oncology work-up
- •Any non-routine surveillance scan
研究组 & 干预措施
Phase 1: Scanxiety Assessment
To see if patient caregiver reports scanxiety (2-5 on the Anxiety Likert Scale).
Scanxiety Assessment to determine if patients are eligible to enroll in the study.
Phase 1 : Two Weeks Prior to Scan, Enrolled Patients will complete
- Demographics Form
- Questions About Treatment Form
- Likert-style anxiety scale These instruments will determine if patients have "Scanxiety" and can participate in Phase 2 of the study.
Phase 2: Intervention Group
Phase 2 participants will be randomized to either the intervention group or the control group using a random number generator sequence.
Two weeks before the scan, those assigned to the Intervention Group will be mailed a Mindful Module Caregiver Packet (Days 2-7) to complete a week before their upcoming scan. On day one they will be sent the STAI Survey via REDCAp to complete along with Mindful Module 1. Each day there will a new module sent to their email. Days 2-7 participants will be sent a daily module. At the end of the module Day 7, the day before the scan, they will be directed to 2 surveys (STAI, Feasibility and Acceptability of the Program to complete before their scan).
Control Group: Patient caregivers will not receive the Mindful Modules Caregiver Packet and will not get the sent the daily mindfulness modules. Will complete above surveys at above timelines as stated in Intervention Group.
干预措施: Mindful Module Caregiver Packet (Other)
结局指标
主要结局
Likert-Style Anxiety Scale
时间窗: Caregivers will complete this 2 weeks before the scan.
Used to determine if the caregivers of pediatric oncology patients experience scanxiety. This one-item instrument scale ranges from 1 (not anxious at all) to 5 (extremely anxious). The goal of this instrument is to grossly establish if Scanxiety is present in caregivers. If caregivers answer between 2 (A little anxious)-5 (Extremely anxious) it demonstrates levels of anxiety.
State-Trait Anxiety Inventory (STAI)
时间窗: If anxiety is demonstrated in caregivers, they will move into Phase 2 of this study either in the Intervention Arm or the Control Arm. The State-Trait Anxiety Inventory (STAI) will be administered on Timepoint Day 1 and again on Timepoint Day 7.
Used to determine if the caregivers of pediatric oncology patients experience scanxiety. This 40-item self-reported survey measures anxiety. These 40 questions are divided into two 20-quesiton sections (one for "state" anxiety, and one for "trait" anxiety). Higher scores demonstrate high levels of anxiety. the scores range from 20-80 \[very high anxiety (\> 65), high anxiety (56-65), moderate anxiety (46-55), low anxiety (36-45) and very low anxiety (\< or = 35).
Feasibility of the Program
时间窗: Will be administered to caregivers in the Intervention Arm Only on Day 7.
This questionnaire measures the ease of completion of the mindfulness modules, the perceived appeal of the mindfulness program, participant interest, likelihood of recommending the program to others, and participation in other mindfulness-based activities (e.g., yoga or meditation) outside of the study in a YES or NO response format.
Acceptability of Intervention Measure (AIM)
时间窗: Will be administered to both Intervention and Control Arm on both Day 1 and Day 7.
To evaluate the study's ability to generate interest in similar programs and its perceived applicability. This 4-question scale has values ranging from 1 (Completely disagree), 2 Disagree, 3 Neither agree nor disagree, 4 Agree, and 5 Completely agree).
Intervention Appropriateness Measure (IAM)
时间窗: Timeframe: Will be administered on both intervention and Control Arm on both Day 1 and Day 7.
To evaluate the study's ability to generate interest in similar programs its, perceived applicability and the likelihood of recommendation to other oncology families. This 4-question scale has values ranging from 1 (Completely disagree), 2 Disagree, 3 Neither agree nor disagree, 4 Agree, and 5 Completely agree).
Feasibility of Intervention Measure (FIM)
时间窗: Will be administered on both intervention and Control Arm on both Day 1 and Day 7.
To evaluate the study's ability to generate interest in its ease of completion. This 4-question scale has values ranging from 1 (Completely disagree), 2 Disagree, 3 Neither agree nor disagree, 4 Agree, and 5 Completely agree).
次要结局
未报告次要终点
研究者
Kimberley Roche
Principal Investigator
Connecticut Children's Medical Center