Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT04059393
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2019-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PCRC-Supported Legacy Intervention in Pediatric Palliative Care
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
Study Overview
Official Title:
Impact of a PCRC-Supported Legacy Intervention in Pediatric Palliative Care
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial studies how well a web-based legacy intervention works in improving the quality of life in caregivers and younger patients with cancer that has come back (recurrent) or does not respond to treatment (refractory). Legacy-making, defined as doing or saying something to be remembered, may reduce the suffering of children with cancer and their caregivers. Currently, there is little information about what kinds of legacy-making activities are helpful from the perspective of children. Using a web-based digital storytelling intervention, this study may help researchers examine what children think about these legacy-making activities and what kinds of activities might be helpful to them.
Detailed Description:
PRIMARY OBJECTIVES:
I. To examine the impact of legacy-making on coping strategies and adjustment outcomes among children with refractory or relapsed cancer.
II. To examine the impact of legacy-making on coping strategies and adjustment outcomes among parent caregivers.
III. To examine the process of implementing a web-based legacy-making intervention for children with refractory or relapsed cancer and their parent caregivers by obtaining parent self-reports (e.g., What did you and your child-like/not like about the intervention? How difficult was it to complete the intervention? What made it difficult? What else you would like to teach us?).
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients participate in a web-based legacy intervention by answering questions about themselves and uploading videos, photographs, and music to create a digital story within 2 weeks.
GROUP II: Patients receive standard of care. Patients have the option to participate in the web-based legacy intervention after 2 months.
I. To examine the impact of legacy-making on coping strategies and adjustment outcomes among children with refractory or relapsed cancer.
II. To examine the impact of legacy-making on coping strategies and adjustment outcomes among parent caregivers.
III. To examine the process of implementing a web-based legacy-making intervention for children with refractory or relapsed cancer and their parent caregivers by obtaining parent self-reports (e.g., What did you and your child-like/not like about the intervention? How difficult was it to complete the intervention? What made it difficult? What else you would like to teach us?).
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients participate in a web-based legacy intervention by answering questions about themselves and uploading videos, photographs, and music to create a digital story within 2 weeks.
GROUP II: Patients receive standard of care. Patients have the option to participate in the web-based legacy intervention after 2 months.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2019-05051 | REGISTRY | NCI, Clinical Trials Reporting Program | View | |
| R01NR015353 | NIH | None | https://reporter.nih.gov/quic… | View |