Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT
Recruiting now · Not applicable
Conditions studied: Head and Neck Cancer, Body Image Disturbance, Body Image, Survivorship, Psychosocial Impairment, Mental Health Issue
In brief
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).
Key facts
- Study ID
- NCT05442957
- Run by
- Medical University of South Carolina
- People needed
- 180
- Starts
- 2023-02-14
- Expected to finish
- 2027-03-30
- Last updated by the study team
- 2025-09-24
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age > 18 years on the day of informed consent
- History of pathologically confirmed squamous cell carcinoma (or histologic variant) of the oral cavity, pharynx, larynx, nose/paranasal sinuses, carcinoma of a major or minor salivary gland, or cutaneous malignancy of the face or neck
- History of curative intent surgery with or without adjuvant therapy, with or without reconstruction
- Completion of oncologic treatment within 12 months of study enrollment (but no sooner than 6 weeks post-treatment completion)
- Patients who complete definitive HNC-directed therapy (e.g., surgery or radiation therapy) but are on adjuvant immunotherapy are considered eligible
- Oncologic treatment refers to cancer-directed therapy; non-cancer surgery (e.g., trachea-esophageal puncture, flap debulking, etc) are not relevant for the purposes of determining eligibility vis a vis completing oncologic treatment within 6-week to 12 months of enrollment
- Cancer-free at the time of accrual
- 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
- 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
- Willingness to be randomized to either BRIGHT or AC
- IMAGE-HN score ≥ 22
You may not qualify if…
- Inability to speak or read English
- Pre-existing, ongoing psychotherapy services for any disorder and the participant is not willing to discontinue the prior therapy for the duration of the proposed trial
- Severe mental illness that would prevent trial participation
Where it is running
- Henry Ford Hospital — Detroit, Michigan, United States (enrolling)
- Washington University in St. Louis — St Louis, Missouri, United States (enrolling)
- Pennsylvania State University — Hershey, Pennsylvania, United States (enrolling)
- Medical University of South Carolina — Charleston, South Carolina, United States (enrolling)
- University of Texas Southwestern — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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