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

Launched by MEDICAL UNIVERSITY OF SOUTH CAROLINA · Jun 29, 2022

Keywords

ClinConnect Summary

The BRIGHT clinical trial is studying how a special online therapy called BRIGHT can help individuals who have survived head and neck cancer and are struggling with how they feel about their body. The trial will involve 180 participants who will be randomly assigned to either the BRIGHT therapy, which uses video sessions to support mental health, or a control group that receives standard supportive care. Researchers aim to understand how these interventions affect body image distress, psychological well-being, and overall quality of life.

To be eligible for this trial, participants must be over 18 years old and have a confirmed history of specific types of head and neck cancers. They should have completed their cancer treatments within the last year and be cancer-free at the time of joining the study. Participants will fill out questionnaires to assess their body image and mental health before and after the intervention. This trial is currently recruiting and welcomes anyone who meets the criteria and is willing to take part in this important research to improve the lives of head and neck cancer survivors.

Gender

ALL

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)
• • 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)