Ignite Creation Date:
2024-05-06 @ 4:24 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04973436
Status:
COMPLETED
Last Update Posted:
2024-05-01
First Post:
2021-07-13
Brief Title:
DBT for Metastatic Lung Cancer
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Dialectical Behavioral Therapy Skills Training for Metastatic Lung Cancer Patients
Status:
COMPLETED
Status Verified Date:
2024-03
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:
LiveWell
Brief Summary:
Metastatic lung cancer patients experience significantly greater psychological distress ie depression anxiety compared to other cancers Psychological distress is as a prognostic indicator for worse clinical outcomes and poorer overall survival in cancer patients Dialectical behavioral therapy DBT is a trans-diagnostic evidence-based psychotherapy that teaches participants a core set of behavioral skills distress tolerance emotion regulation mindfulness interpersonal effectiveness to cope more effectively with emotional and physical symptoms The proposed study seeks to adapt and pilot test DBT skills training for patients with metastatic lung cancer using the ADAPT-ITT framework Participants will be metastatic lung cancer patients who score 3 on the National Comprehensive Cancer Network distress thermometer Phase I aims to use focus groups and interviews with key stakeholders metastatic lung cancer patients N20 thoracic oncology providers N6 clinicians with expertise in survivorship and behavioral symptom management N6 to determine if and how DBT skills training must be modified for implementation with metastatic lung cancer patients Adapted material will be reviewed by topical experts in DBT and implementation science to produce a manualized adapted DBT skills training protocol for metastatic lung cancer patients LiveWell Phase II aims to pilot test LiveWell N30 to assess feasibility acceptability and examine pre-to-post intervention outcomes of psychological distress ie depression and anxiety fatigue dyspnea pain emotion regulation tolerance of uncertainty and DBT coping skill use LiveWell will consist of coping skills training sessions delivered either in-person or via videoconferencing technology Study measures will be collected at baseline immediately post-intervention and 1-month post-intervention
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