Improving body image for head and neck cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multi-center randomized clinical trial aims to help head and neck cancer survivors who experience significant body image distress. Participants will be randomly assigned to either the BRIGHT intervention, which involves brief video tele-cognitive behavioral therapy, or an Attention Control group that receives supportive care. The study will assess changes in body image distress, psychological well-being, and quality of life over several months using validated measures. Additionally, interviews and site visits will be conducted to identify barriers and facilitators for implementing the BRIGHT intervention in clinical settings.

Why it matters

Who can join: the full rules

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

Where it's running

• Henry Ford Hospital
  Detroit, Michigan, United States Recruiting
• Washington University in St. Louis
  St Louis, Missouri, United States Recruiting
• Pennsylvania State University
  Hershey, Pennsylvania, United States Recruiting
• Medical University of South Carolina
  Charleston, South Carolina, United States Recruiting
• University of Texas Southwestern
  Dallas, Texas, United States Recruiting

Study contacts

• Study coordinator: Evan M Graboyes, MD
• Email: graboyes@musc.edu
• Phone: 843-792-0719

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Improving nasal-sounding speech and swallowing in head and neck cancer survivors with velopharyngeal dysfunction

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• Nurse counselling and personalized survivorship care plans for head and neck cancer survivors

  This trial will try a nurse-led motivational counselling session combined with a personalized treatment summary and survivorship care plan to help people 3-6 months after head and neck cancer treatment follow recommended care.

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• A program to support head and neck cancer survivors and their caregivers

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• Phenotype-based Pain Guidance for Head and Neck Cancer-Related Pain (pilot)

  This pilot test sees if tailoring pain treatment to a patient’s pain type can reduce head and neck cancer pain in adults who haven’t started cancer treatment yet.

  Recruiting Phase 2 Shaukat Khanum Memorial Cancer Hospital & Research Centre · Lahore, Punjab Province · NCT07919444

• Airway ultrasound in head and neck cancer patients

  This observational study tests whether neck ultrasound measurements of the airway match CT measurements in adults with maxillofacial cancer undergoing surgery with anesthesia.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.