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BRIGHT Study for Head & Neck Cancer Survivors

This study, called BRIGHT, is for people aged 18 and older who have had head and neck cancer and are experiencing body image distress (feeling unhappy or uncomfortable with how their body looks). It's testing two different behavioral interventions delivered through video calls: BRIGHT, which is a type of talk therapy called cognitive behavioral therapy (CBT), and Attention Control, which is a supportive care program. Both programs involve 6 weekly, one-hour sessions. The main goal is to see if BRIGHT can reduce body image distress after 9 months, and also to understand how it might improve your overall well-being and quality of life. We are looking for 180 participants.

Study design
This is a multi-site randomized clinical trial, meaning participants will be randomly assigned to one of two groups. The study plans to enroll 180 participants.
What's involved
You would participate in 6 weekly, 60-minute sessions delivered via video call. The study will also involve completing measures of body image distress, psychological and social well-being, and quality of life.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 9 months after randomization, with assessments at 2, 3, 6, and 9 months.

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NCT05442957

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

Recruiting
NAAges 18+InterventionalSupportive care
Medical University of South Carolina
~180 participants
Updated 2025-09-24 on ClinicalTrials.gov
What's tested:BRIGHTAttention Control

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
IMAGE-HN
Measured over 9 months

Conditions

Head and Neck Cancer
Body Image Disturbance
Body Image
Survivorship
Psychosocial Impairment
Mental Health Issue

Explore related trials

Malignant Head and Neck Neoplasm

Where it's being run

5 sites across 5 states
Michigan1
Missouri1
Pennsylvania1
South Carolina1
Texas1

Who to contact

Evan M Graboyes, MD
[email protected]
843-792-0719
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

patients with known indolent malignancies (e.g., non-melanoma skin cancer, low risk thyroid cancer, untreated prostate cancer, etc) would not exclude a patient from the study 6. No planned significant HNC ablative or reconstructive surgery (defined by a postoperative inpatient stay of at least three days) during the study intervention or follow-up period as determined by the HNC oncologic surgeon at the time of study accrual 7. Willingness to be randomized to either BRIGHT or AC 8. IMAGE-HN score ≥ 22

What this trial measures

  • IMAGE-HN9 months

    The IMAGE-HN is a 24-item, validated patient-reported outcome measure (PROM) of HNC-related BID. Items are rated on a 5-point Likert scale from 'Never' (0) to 'Always' (4). The total global score is calculated by summing item responses across 21 items (all items except 3, 4, and 19). Total IMAGE-HN scores on the global domain (21 questions) range from 0-84; higher scores indicate worse HNC-related BID. An IMAGE-HN score of \> 22 indicates clinically-significant HNC-related BID and a change in IMAGE-HN score of \> 9 points is clinically meaningful.