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NCT03538587 · ClinicalTrials.gov registry record · NA
Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers
A NA study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- NA
- Development phase
- 10
- Enrollment target
NCT03538587: Completed NA study, sponsored by National Cancer Institute (NCI).
NCT03538587 is a NA study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03538587, a NA study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- NA
- Development phase
- 10 participants
- Enrollment target
Study Summary
Background: People cope with cancer in different ways. Mindfulness means focusing on the present moment with an open mind. Researchers want to see if this can help children and young adults with a high-grade high-risk cancer with poor prognosis. Objective: To learn if mindfulness is feasible and acceptable for children and young people with high-grade high-risk cancer with poor prognosis and their caregivers. Eligibility: Children ages 5-24 with a high-grade or high-risk cancer, with a caregiver who agrees to do the study Must have internet access (participants may borrow an iPod for the study) Must speak English Design: All participants will complete questionnaires. These will be about feelings, physical well-being, quality of life, and mindfulness. Researchers will review children's medical records. Participants will be randomly put in the mindfulness group or the standard care group. Participants in the standard care group will: Get general recommendations for coping with cancer Have check-in sessions 1 and 3 weeks after starting. These will last about 10 minutes each. After participants finish the standard care group, they may be able to enroll in the mindfulness group. Participants in the mindfulness group will: Attend an in-person mindfulness training session. The child participant will meet with one research team member for 90 minutes while the parent participant meets with another. Then they will come together for a half hour. Practice mindfulness exercises at least 4 days a week for 8 weeks. Be asked to respond to weekly emails or texts asking about their mindfulness practice Get a mindfulness kit with things to help them do their mindfulness activities at home. Have a 30-minute check-in with their coach 1 and 3 weeks after starting. This can be in person or by video chat. All participants (from both groups) will be asked to answer follow-up questions about 8 and 16 weeks after starting the study. Participants will be paid $20 for each
Interventions
- BEHAVIORAL Psychoeducation
- BEHAVIORAL Enhanced Mindfulness Intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-01-29 |
| Est. Completion | 2022-09-13 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03538587
The ClinicalTrials.gov registry entry for NCT03538587 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Psychoeducation is the first listed.
NCT03538587 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03538587 about?
NCT03538587 is a clinical study titled "Feasibility and Preliminary Efficacy of a Mindfulness-based Intervention for Children and Young Adults With High Grade or High-Risk Cancer and Their Caregivers". Background: People cope with cancer in different ways. Mindfulness means focusing on the present moment with an open mind. Researchers want to see if this can help children and young adults with a high-grade high-risk cancer with poor prognosis. Objective: To learn if mindfulness is feasible and ...
What is the current status of trial NCT03538587?
This trial is currently completed. It is a NA study. The enrollment target is 10 participants. The study started on 2019-01-29. Estimated completion is 2022-09-13.
What interventions are being tested in trial NCT03538587?
The interventions under investigation include: Psychoeducation (BEHAVIORAL), Enhanced Mindfulness Intervention (BEHAVIORAL).
Who is sponsoring clinical trial NCT03538587?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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