Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06371768
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-11
Brief Title:
Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Symptom Management and Transitioning to Engagement With Post-treatment Care for Adolescent and Young Adult Cancer Survivors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
AYA STEPS
Brief Summary:
The purpose of this study is to determine the effectiveness of a digital health program called AYA STEPS which is designed to help adolescent and young adult AYA cancer survivors manage symptoms and engage in recommended follow-up care
Detailed Description:
The investigators have developed an accessible digital health intervention AYA STEPS Symptom Management and Transitioning to Engagement with Post-Treatment Care for AYA Survivors designed to enhance adolescent and young adult AYA cancer survivors abilities to manage their high symptom burden and engage in follow-up health care Informed by the Obesity-Related Behavioral Intervention Trials ORBIT Model of intervention development AYA STEPS has been systematically and rigorously developed and refined through the PIs prior work K08CA245107 AYA STEPS is organized into six remotely delivered sessions providing cognitive-behavioral and patient activation theory-based skills expected to lead to lower symptom burden and increased health care engagement by improving AYAs self-efficacy for symptom management and activation The investigators propose a randomized controlled trial to examine the efficacy of AYA STEPS compared to AYA educational information for improving symptom burden and health care engagement for AYA survivors N260 who received cancer care in diverse health care settings ie rural urban medically underserved areas across North Carolina Self-efficacy and patient activation will be examined as mediators of intervention effects The planned study has the potential to produce clinically impactful health benefits for an underserved and understudied group of cancer survivors who have significant symptom burden experience barriers to care engagement and have limited access to AYA-specific behavioral interventions
Study Oversight
Has Oversight DMC:
None
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?:
None