Actively Recruiting
Led by Medical University of South Carolina · Updated on 2025-09-24
180
Participants Needed
5
Research Sites
8 weeks
Total Duration
M
Medical University of South Carolina
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
Researchers are evaluating a new brief video tele-cognitive behavioral therapy called BRIGHT for survivors of head and neck cancer who experience significant body image distress. This multi-center randomized clinical trial compares BRIGHT to an attention control supportive care intervention to see if BRIGHT can reduce body image distress and improve psychological and social well-being and quality of life. The study will include 180 participants and explore how BRIGHT affects coping skills and automatic negative thoughts related to body image. Participants will be randomly assigned to one of two groups: BRIGHT or Attention Control (AC). BRIGHT involves six weekly 60-minute sessions conducted one-on-one by a licensed clinical psychologist via video telehealth. Sessions cover topics such as understanding body image, self-monitoring, cognitive restructuring, coping strategies, social support, and planning for setbacks. The AC group receives six weekly 60-minute tele-supportive care sessions addressing non-body image topics like survivorship, side effects, psychosocial aspects, nutrition, financial distress, and cancer recurrence. Both interventions control for attention and delivery method. Throughout the study, participants will complete the IMAGE-HN questionnaire to measure body image distress, along with assessments of psychological symptoms, social participation, quality of life, and coping mechanisms at 2, 3, 6, and 9 months after randomization. Researchers will also conduct interviews and site visits to understand how to best implement BRIGHT in clinical care. The total follow-up lasts 9 months, with a focus on body image and mental health outcomes among head and neck cancer survivors.
CONDITIONS
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT
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You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Duration - 6 weeks
Participants receive 6 weekly 60-minute sessions of either BRIGHT tele-CBT or Attention Control via video telehealth.
Weekly sessions for 6 weeks (remote)
Duration - Up to 9 months post-randomization
Participants are monitored for psychological and social well-being outcomes up to 9 months after randomization.
Assessments at 2, 3, 6, and 9 months post-randomization (remote or in-person)
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
E
Evan M Graboyes, MD
T
Taylor McLeod, MPH
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Evan M Graboyes, Stacey N Maurer, Emily Kistner-Griffin...
https://pubmed.ncbi.nlm.nih.gov/40139457