AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingNAAges 18 Years - anyAllMedical University of South Carolina
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Age \> 18 years on the day of informed consent 2. 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 3. History of curative intent surgery with or without adjuvant therapy, with or without reconstruction 4. Completion of oncologic treatment within 12 months of study enrollment (but no sooner than 6 weeks post-treatment completion) 1. Patients who complete definitive HNC-directed therapy (e.g., surgery or radiation therapy) but are on adjuvant immunotherapy are considered eligible 2. 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 5. 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 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 โ‰ฅ 22 Exclusion Criteria: 1. Inability to speak or read English 2. 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 3. Severe mental illness that would prevent trial participation
๐Ÿ’Š

What it tests

  • BRIGHT
  • Attention Control
๐Ÿ“

Where

5 sites
Henry Ford Hospital
Detroit, United States
Washington University in St. Louis
St Louis, United States
Pennsylvania State University
Hershey, United States
Medical University of South Carolina
Charleston, United States
University of Texas Southwestern
Dallas, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy