Ignite Creation Date:
2024-05-06 @ 5:50 PM
Last Modification Date:
2024-10-26 @ 2:36 PM
Study NCT ID:
NCT05442957
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2022-06-29
Brief Title:
Building a Renewed ImaGe After Head Neck Cancer Treatment BRIGHT Multi-Site RCT
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
A Multi-Site Parallel-Group Randomized Clinical Trial Comparing a Brief Tele-Cognitive Behavioral Therapy Intervention BRIGHT With Attention Control for the Reduction of Body Image-Related Distress Among Head and Neck Cancer Survivors
Status:
RECRUITING
Status Verified Date:
2024-10
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:
BRIGHT
Brief Summary:
In this multi-center randomized clinical trial head and neck cancer HNC survivors with clinically significant body image distress BID N180 will be randomized to BRIGHT a brief video tele-cognitive behavioral therapy intervention or Attention Control AC a manualized tele-supportive care intervention that controls for professional attention dose delivery method and common factors HNC survivors will complete IMAGE-HN a validated patient-reported outcome measure PROM of HNC-related body image distress BID primary endpoint measures of psychological and social well-being and quality of life QOL and measures of theory-derived mechanisms of change underlying BRIGHT mediators
Detailed Description:
We will perform a multi-site randomized clinical trial RCT comparing BRIGHT with AC to test our hypotheses that BRIGHT reduces BID and improves psychological and social well-being and QOL at 2 3 6 and 9-months post-randomization by enhancing body image coping skills and decreasing unhelpful automatic thoughts HNC survivors with clinically significant BID N180 from multiple sites in the United States will be randomized 11 to BRIGHT or AC We will conduct semi-structured interviews with key stakeholders n10site and in-depth site visits to assess barriers and facilitators of the adoption of BRIGHT and develop an implementation toolkit to enhance the future adoption of BRIGHT into routine clinical care
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 |
|---|---|---|---|
| R37CA269385 | NIH | None | httpsreporternihgovquickSearchR37CA269385 |