Improving body image for head and neck cancer survivors
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
This study is testing a new video therapy program to see if it can help head and neck cancer survivors feel better about their body image and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of South Carolina Academic / other |
| Drugs / interventions | immunotherapy, radiation |
| Locations | 5 sites (Detroit, Michigan and 4 other locations) |
| Trial ID | NCT05442957 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who have completed treatment for head and neck cancer within the last 12 months and are cancer-free.
Not a fit: Patients who are currently undergoing significant head and neck surgery or have untreated indolent malignancies may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve the body image and overall quality of life for head and neck cancer survivors.
How similar studies have performed: Other studies have shown promise in using cognitive behavioral therapy for improving psychological outcomes in cancer survivors, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Detroit, Michigan and 4 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.