Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:03 PM
Ignite Modification Date:
2025-12-24 @ 7:03 PM
NCT ID:
NCT05442957
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 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 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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05442957
Study Brief:
Protocol Section:
NCT05442957