Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT (NCT05442957)
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
๐ฉบ Plain-English Summary (8th-Grade Level)
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).
Who can join: Review the eligibility criteria below.
Location: Henry Ford Hospital โ Detroit, Michigan
Age range: 18 Years
๐งช Interventions in This Study
- BRIGHT (BEHAVIORAL)
- Attention Control (BEHAVIORAL)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (5 Sites)
- Henry Ford Hospital โ Detroit, Michigan
- Washington University in St. Louis โ St Louis, Missouri
- Pennsylvania State University โ Hershey, Pennsylvania
- Medical University of South Carolina โ Charleston, South Carolina
- University of Texas Southwestern โ Dallas, Texas
๐ Contact the Study Coordinator
Phone: (843) 792-0719
Email: graboyes@musc.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Head and Neck Cancer
- Window Study of Nivolumab With or Without Ipilimumab in Squamous Cell Carcinoma of the Oral Cavity โ Boston, Massachusetts
- Imaging With a PET Agent for Detection of Cancers of the Head and Neck โ New York, New York
- Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Head and Neck Cancer โ Miami, Florida
- ASP-1929 Photoimmunotherapy (PIT) Study in Recurrent Head/Neck Cancer for Patients Who Have Failed at Least Two Lines of Therapy โ Miami, Florida
- ASP-1929 Photoimmunotherapy (PIT) Study in Patients With Recurrent Head/Neck Cancer โ Bethesda, Maryland
- "QUAD SHOT" Radiotherapy With Pembrolizumab in Patients With Recurrent Head & Neck Cancer โ Oklahoma City, Oklahoma
Explore by condition: All Head and Neck Cancer clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.