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Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT — BRIGHT  

Head and Neck Cancer Clinical Trial

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

Clinical Trial Summary

In this multi-center randomized clinical trial, head and neck cancer (HNC) survivors with clinically significant body image distress (BID) (N=180) 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).

Clinical Trial 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 (N=180) from the Medical University of South Carolina (MUSC), Washington University School of Medicine (WUSM), and Henry Ford Health (HFH) will be randomized 1:1 to BRIGHT or AC. We will conduct semi-structured interviews with key stakeholders (n=10/site) 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05442957
Study type Interventional
Source Medical University of South Carolina
Contact Evan M Graboyes, MD
Phone 843-792-0719
Email graboyes@musc.edu
Status Recruiting
Phase N/A
Start date February 14, 2023
Completion date March 30, 2027
View Details
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