Easing Scan Anxiety in Pediatric Oncology Caregivers Through Meditation-based Programs
Purpose
"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.
Conditions
- Caregiver Anxiety
- Caregiver Anxiety Related to Cancer Imaging
- Pediatric Oncology
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- 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)
Exclusion Criteria
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- Phase 1: To determine if scanxiety occurs in the caregivers of pediatric oncology patients relative to imaging studies at Connecticut Children's. Phase 2: To test whether a MBSR-influenced online intervention program decreases caregiver scanxiety.
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
No Intervention 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. |
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Experimental 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. |
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Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Kimberley Roche
Detailed Description
"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.
