Ignite Creation Date:
2024-07-17 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06464562
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-18
First Post:
2024-06-13
Brief Title:
LiveWell Adapted DBT Skills Training for Metastatic Lung Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
LiveWell An Adapted Dialectical Behavioral Therapy Skills Training Protocol for Patients Living With Metastatic Lung Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
Patients are living longer with metastatic lung cancer ie metavivors due to therapeutic advances but face significant challenges Most metavivors will ultimately die of cancer and must navigate the duality of living while dying Unsurprisingly metavivors endorse high psychological distress eg anxiety depression illness non-acceptance high symptom burden eg fatigue dyspnea pain and poor quality of life Psychosocial interventions can improve outcomes but existing paradigms are not designed to help metavivors navigate the emotional turbulence of living with metastatic disease Dialectical Behavioral Therapy DBT Skills Training is an evidence-based treatment that teaches patients transdiagnostic easy-to-use skills to both accept things as they are mindfulness distress tolerance and change things within their control emotion regulation interpersonal effectiveness to better navigate life challenges However DBT Skills Training has rarely been applied in patients with chronic illness The investigators adapted DBT Skills Training eg intervention dose delivery content for patients living with metastatic lung cancer to create LiveWell an 8-session Skills Training protocol delivered one-on-one via videoconference Building on preliminary data and aligned with the ORBIT model for behavioral intervention development the first phase of this study K99 Aim 1 1 year aims to iteratively refine LiveWell using 1 qualitative exit interview data from a proof-of-concept study 2 an advisory board of interested parties 3 the Dynamic Sustainability Framework from implementation science and 4 user testing n10 The K99 phase will produce a standardized protocol and procedures for the R00 The second independent phase of the study R00 Aim 2 3 years will be a Phase IIB randomized pilot trial to test study feasibility acceptability and outcome patterns suggesting the efficacy of LiveWell compared to Enhanced Usual Care EUC Lung cancer metavivors n80 20 non-White receiving care at an NCI-designated center and endorsing distress 310 will be randomized 11 The investigators hypothesize that 1 LiveWell and EUC protocols and procedures will show evidence of feasibility accrual N8020 months 80 adherence to interventions and assessments 20 attrition and acceptability 35 satisfaction study procedures 3 mean intervention satisfaction LiveWell and 2 LiveWell will improve quality of life primary outcome and reduce psychological distress depression anxiety illness acceptance and symptom burden fatigue dyspnea pain secondary outcomes from baseline to post-treatment compared to EUC The investigators will explore emotion regulation as a mechanism of change Findings from this study will inform an R01 submission to conduct a Phase III efficacy trial If successful LiveWell will improve metavivor quality of life and provide a promising psychosocial intervention paradigm for other metavivors and patients with chronic illness
Detailed Description:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1K99CA286959 | NIH | None | None |