Easing Scan Anxiety in Pediatric Oncology Caregivers Through Meditation-based Programs
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKimberley Roche
About this trial
"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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mindful Module Caregiver Packet
Other interventionIf Scanxiety was identified, patient's caregiver will receive the Mindful Module Caregiver Packet. The intervention group will receive the daily module on Days 1-7; Day 7 being the day before scan. At the end of the module (Day 7), they will be directed to two surveys (STAI and Feasibility of the Program).
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Phase 1: Scanxiety AssessmentNo intervention 0 interventions
Group B: Phase 2: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Likert-Style Anxiety Scale
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.
Time frame
Caregivers will complete this 2 weeks before the scan.2
State-Trait Anxiety Inventory (STAI)
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).
Time frame
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 7.3
Feasibility of the Program
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.
Time frame
Will be administered to caregivers in the Intervention Arm Only on Day 7.4
Acceptability of Intervention Measure (AIM)
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).
Time frame
Will be administered to both Intervention and Control Arm on both Day 1 and Day 7.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Kimberley Roche
Lead sponsor
Connecticut Children's Medical Center
Sponsor institution
Connecticut Children's Medical Center
Collaborator
UConn Health
Collaborator
Source ClinicalTrials.gov