Randomized Trial Comparing BRIGHT Tele-Cognitive Behavioral Therapy to Supportive Care for Reducing Body Image Distress in Head and Neck Cancer Survivors
Led by Medical University of South Carolina · Updated on 2025-09-24
180
Participants Needed
5
Research Sites
8 weeks
Total Duration
AI-Summary
What this Trial Is About
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
Brief Title
Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT
Research Team
E
Evan M Graboyes, MD
T
Taylor McLeod, MPH
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This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
Factors
BRIGHT (Tele-CBT)
Attention Control (Video-Based Supportive Care)
What it is
A structured, manualized cognitive behavioral therapy (CBT) specifically addressing body image distress in head and neck cancer survivors. Delivered in six weekly one-hour sessions by a psychologist using secure telemedicine video.
A structured, manualized video-based supportive care program focusing on general head and neck cancer survivorship needs, excluding body image-specific approaches. Matched in dose and delivery method to BRIGHT, but content avoids cognitive behavioral strategies affecting body image.
Role in the trial
Intervention being tested for its effect on body image-related distress after curative treatment.
Serves as the control to match attention, session time, and interaction but does not actively target body image distress.
Primary use or focus
Designed to reduce body image-related distress in people treated for head and neck cancer.
Aims to provide supportive care for general survivorship issues after treatment for head and neck cancer, not focused on body image.
How it is given or performed
Six individual 60-minute weekly sessions with a psychologist, delivered one-on-one via video telemedicine using a structured therapy manual.
Six individual 60-minute weekly sessions with an empathic interventionist, delivered by video telemedicine, matching BRIGHT in structure but with non-body image supportive content.
Evidence status
Currently being studied in a randomized controlled trial; there are no published outcomes on effectiveness yet for BRIGHT in this population.
Currently serves as the control in the ongoing randomized trial; there are no published comparative effectiveness results for this approach in body image distress in this population.
Important limitations
The effectiveness of BRIGHT for reducing body image distress is not yet established; results from this trial are not available. Real-world use may be limited to centers with psychologist access and telemedicine capacity.
The control program provides general survivorship support but does not target body image distress. Effectiveness for body image or psychological outcomes is unknown, and results are not yet available from the trial.
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
Age greater than 18 years on the day of informed consent
History of confirmed squamous cell carcinoma or similar head and neck cancers
Completed curative intent surgery with or without additional therapy
Oncologic treatment finished within 6 weeks to 12 months before enrollment
Cancer-free at the time of enrollment
No planned major head and neck surgery requiring hospital stay during study or follow-up
Willingness to be randomly assigned to either BRIGHT or Attention Control
IMAGE-HN score of 22 or higher indicating significant body image distress
You will not qualify if you...
Inability to speak or read English
Currently receiving psychotherapy for any disorder and unwilling to stop during the trial
Severe mental illness that would prevent participating in the trial
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote)
Treatment
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)
Follow-up
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)
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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Published Research Related To This Trial
Protocol for a multisite, 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.
Evan M Graboyes, Stacey N Maurer, Emily Kistner-Griffin...