Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT
Trial Parameters
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Brief Summary
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).
Eligibility Criteria
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 a