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

Last updated: September 18, 2025
Sponsor: Medical University of South Carolina
Overall Status: Active - Recruiting

Phase

N/A

Condition

Weight Loss

Nasopharyngeal Cancer

Human Papilloma Virus (Hpv)

Treatment

BRIGHT

Attention Control

Clinical Study ID

NCT05442957
PRO 00110248
R37CA269385
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 orminor salivary gland, or cutaneous malignancy of the face or neck

  3. History of curative intent surgery with or without adjuvant therapy, with or withoutreconstruction

  4. Completion of oncologic treatment within 12 months of study enrollment (but nosooner than 6 weeks post-treatment completion)

  5. Patients who complete definitive HNC-directed therapy (e.g., surgery orradiation therapy) but are on adjuvant immunotherapy are considered eligible

  6. Oncologic treatment refers to cancer-directed therapy; non-cancer surgery (e.g., trachea-esophageal puncture, flap debulking, etc) are not relevant forthe purposes of determining eligibility vis a vis completing oncologictreatment within 6-week to 12 months of enrollment

  7. Cancer-free at the time of accrual

-patients with known indolent malignancies (e.g., non-melanoma skin cancer, low riskthyroid cancer, untreated prostate cancer, etc) would not exclude a patient from thestudy

  1. No planned significant HNC ablative or reconstructive surgery (defined by apostoperative inpatient stay of at least three days) during the study interventionor follow-up period as determined by the HNC oncologic surgeon at the time of studyaccrual

  2. Willingness to be randomized to either BRIGHT or AC

  3. IMAGE-HN score ≥ 22

Exclusion

Exclusion Criteria:

  1. Inability to speak or read English

  2. Pre-existing, ongoing psychotherapy services for any disorder and the participant isnot willing to discontinue the prior therapy for the duration of the proposed trial

  3. Severe mental illness that would prevent trial participation

Study Design

Total Participants: 180
Treatment Group(s): 2
Primary Treatment: BRIGHT
Phase:
Study Start date:
February 14, 2023
Estimated Completion Date:
March 30, 2027

Study Description

We will perform a multi-site randomized clinical trial (RCT) comparing BRIGHT with AC to test our hypotheses that BRIGHT reduces BID and improves psychological and social well-being and QOL at 2, 3, 6, and 9-months post-randomization by enhancing body image coping skills and decreasing unhelpful automatic thoughts. HNC survivors with clinically significant BID (N=180) from multiple sites in the United States will be randomized 1:1 to BRIGHT or AC. We will conduct semi-structured interviews with key stakeholders (n=10/site) and in-depth site visits to assess barriers and facilitators of the adoption of BRIGHT and develop an implementation toolkit to enhance the future adoption of BRIGHT into routine clinical care.

Connect with a study center

  • Henry Ford Hospital

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Hospital

    Detroit 4990729, Michigan 5001836 48202
    United States

    Active - Recruiting

  • Washington University in St. Louis

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University in St. Louis

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Pennsylvania State University

    Hershey 5193342, Pennsylvania 6254927 16802
    United States

    Active - Recruiting

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston 4574324, South Carolina 4597040 29425
    United States

    Active - Recruiting

  • University of Texas Southwestern

    Dallas, Texas 75235
    United States

    Site Not Available

  • University of Texas Southwestern

    Dallas 4684888, Texas 4736286 75235
    United States

    Active - Recruiting

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