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A Multi-Site, 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

Primary Investigator
Forner, David
Status
OPEN TO ACCRUAL
Phase
NA
NCT Number
NCT05442957
UM Number
2025.015
Age Group
Adults
Management Group
CTSU - Oncology
Oncology Group
Head, Neck, and Endocrine Malignancies
ID (Protocol)
57138
Secondary Protocol No
HUM00267865
Scope
Unspecified
Sponsor Type
Institutional
Disease Site
Larynx
Lip, Oral Cavity and Pharynx
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: 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)
  •   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 > 22
Exclusion Criteria
  •   1. Inability to speak or write English
  •   2. Pre-existing, ongoing CBT services for other disorders and the participant is not willing to discontinue the prior therapy for the duration of the proposed trial
  •   3. Initiation or adjustment ( 3 months of baseline) of psychotropic medication
  •   4. Severe psychiatric comorbidity (e.g., suicidal ideation, psychosis)