Actively Recruiting
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT
Led by Medical University of South Carolina · Updated on 2025-09-24
180
Participants Needed
5
Research Sites
215 weeks
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years on the day of informed consent
- History of pathologically confirmed squamous cell carcinoma or related head and neck cancer
- History of curative intent surgery with or without additional therapy or reconstruction
- Completion of oncologic treatment between 6 weeks and 12 months before enrollment
- Patients on adjuvant immunotherapy after definitive therapy are eligible
- Cancer-free at the time of enrollment
- No planned major head and neck surgery requiring at least 3 days inpatient stay during the study
- Willingness to be randomized to either BRIGHT or Attention Control
- IMAGE-HN score of 22 or higher
You will not qualify if you...
- Unable to speak or read English
- Currently receiving psychotherapy for any disorder and unwilling to stop it during the trial
- Severe mental illness preventing participation in the trial
AI-Screening
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Trial Site Locations
Total: 5 locations
1
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
2
Washington University in St. Louis
St Louis, Missouri, United States, 63110
Actively Recruiting
3
Pennsylvania State University
Hershey, Pennsylvania, United States, 16802
Actively Recruiting
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
5
University of Texas Southwestern
Dallas, Texas, United States, 75235
Actively Recruiting
Research Team
E
Evan M Graboyes, MD
CONTACT
T
Taylor McLeod, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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