160 Participants NeededMy employer runs this trial

Meditation-Based Programs for Scanxiety

KR
AB
Overseen ByAdam Barselau, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Kimberley Roche
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the anxiety caregivers of pediatric cancer patients feel when their child undergoes scans, a phenomenon known as "scanxiety." Researchers aim to determine if this anxiety exists and whether a meditation-based program, specifically the Mindful Module Caregiver Packet, can help reduce it. Participants will be divided into two groups: one will use a mindfulness program, and the other will not. Caregivers of children or young adults with cancer who have routine scans scheduled soon might be a good fit.

As an unphased study, this trial offers caregivers the chance to contribute to research that could enhance emotional support strategies.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It focuses on a meditation-based program for managing stress, so it's unlikely that medication changes are required.

What prior data suggests that this meditation-based program is safe for caregivers?

Research has shown that mindfulness programs like the Mindful Module Caregiver Packet are generally safe and easy to manage. Meditation and mindfulness techniques have been used in various situations to help reduce stress and anxiety. Past studies have demonstrated positive effects with minimal side effects. For instance, programs similar to the Mindful Module have helped reduce anxiety in people with cancer and their families.

Participants in these programs often report feeling calmer and less stressed. The likelihood of unwanted side effects is low, making mindfulness-based activities a safe way to manage stress, including "scanxiety" (anxiety related to medical tests).

While specific detailed data about side effects for this particular program is not available, mindfulness practices are generally considered safe for most people. If there are any concerns, consulting a healthcare provider is advisable.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of mindfulness as a tool to address scanxiety, a specific type of anxiety experienced before medical scans. Unlike traditional treatments for anxiety, which often rely on medications or therapy sessions, this approach uses a Mindful Module Caregiver Packet. This packet offers daily mindfulness exercises that can be easily completed at home, providing a non-invasive, accessible method that empowers patients and caregivers to manage anxiety proactively. By focusing on mindfulness, the trial hopes to find out if this method can effectively reduce anxiety levels and improve the overall scan experience for patients.

What evidence suggests that the Mindful Module Caregiver Packet is effective for managing scanxiety?

Research has shown that mindfulness-based stress reduction (MBSR) programs can help reduce anxiety. Studies have found these programs effective in lowering stress for caregivers of people with serious illnesses. One study found that MBSR improved anxiety and sleep quality in female caregivers. Another study showed that these programs can reduce stress and improve well-being. In this trial, participants in the intervention group will receive the Mindful Module Caregiver Packet, which might help manage anxiety related to medical scans for caregivers of children with cancer.13467

Who Is on the Research Team?

KR

Kimberley Roche, MSN, PPCNP-BC, APRN

Principal Investigator

Connecticut Children's Medical Center

Are You a Good Fit for This Trial?

This trial is for adults who are caregivers of children or young people with cancer, whose loved one has a routine scan scheduled in the next 3 months. Participants must speak and read English, be able to eat a raisin, have a smartphone or tablet for texts, and not have cognitive delays.

Inclusion Criteria

I am willing and able to eat a raisin if asked.
Able to understand spoken English and be able to read written English
I am 18 years old or older.
See 4 more

Exclusion Criteria

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
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (virtual)

Scanxiety Assessment

Caregivers complete demographic and anxiety assessment forms to determine scanxiety levels

2 weeks
1 visit (virtual)

Intervention

Participants in the intervention group receive daily mindfulness modules to complete before the scan

1 week
Daily virtual modules

Follow-up

Participants complete surveys to assess anxiety and program feasibility

1 week
2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Mindful Module Caregiver Packet

Trial Overview

The study tests whether a mindfulness meditation program (delivered as a Mindful Module Caregiver Packet) can help reduce anxiety related to scans ('scanxiety') among pediatric oncology caregivers. The intervention is compared to usual care.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Phase 2: Intervention GroupExperimental Treatment1 Intervention
Group II: Phase 1: Scanxiety AssessmentActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Kimberley Roche

Lead Sponsor

Connecticut Children's Medical Center

Collaborator

Trials
76
Recruited
30,000+

UConn Health

Collaborator

Trials
218
Recruited
59,100+

Citations

Anxiety & Depression Association of America

Other: Mindful Module Caregiver Packet If Scanxiety was identified, patient's caregiver will receive the Mindful Module Caregiver Packet.

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