An interventional study of Mindful Module Caregiver Packet in Caregiver Anxiety, Caregiver Anxiety Related to Cancer Imaging and Pediatric Oncology, sponsored by Kimberley Roche. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-19.
Sponsored by Kimberley Roche · Not applicable, Interventional, and Treatment
"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.
"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.
This is the only study on the registry with Kimberley Roche as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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 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.
Other: Mindful Module Caregiver Packet
If 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).
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.
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.
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.
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.
Intervention Appropriateness Measure (IAM)
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).
Time frame: Timeframe: Will be administered on both intervention and Control Arm on both Day 1 and Day 7.
Feasibility of Intervention Measure (FIM)
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).
Time frame: Will be administered on both intervention and Control Arm on both Day 1 and Day 7.
Plan to share: No
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.