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Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT
NCT05442957 · View on ClinicalTrials.gov ↗
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).
Conditions Studied
Interventions
- BEHAVIORAL Attention Control
- BEHAVIORAL BRIGHT
Study Locations (5)
Michigan
- Henry Ford Hospital — Detroit
Missouri
- Washington University in St. Louis — St Louis
Pennsylvania
- Pennsylvania State University — Hershey
South Carolina
- Medical University of South Carolina — Charleston
Texas
- University of Texas Southwestern — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 180 participants |
| Start Date | 2023-02-14 |
| Est. Completion | 2027-03-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05442957
The ClinicalTrials.gov registry entry for NCT05442957 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Medical University of South Carolina, which has 643 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 6 conditions, with Head and Neck Cancer appearing as the primary indexed condition, and to 2 interventions — of which Attention Control is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05442957 reports 5 study locations spanning 5 distinct geographic areas — top geographies include Michigan, Missouri, Pennsylvania. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05442957 about?
NCT05442957 is a clinical study titled "Building a Renewed ImaGe After Head & Neck Cancer Treatment (BRIGHT) Multi-Site RCT". 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 i...
What is the current status of trial NCT05442957?
This trial is currently recruiting. It is a NA study. The enrollment target is 180 participants. The study started on 2023-02-14. Estimated completion is 2027-03-30.
What conditions does trial NCT05442957 study?
This clinical trial studies the following conditions: Head and Neck Cancer, Mental Health Issue, Survivorship, Body Image, Body Image Disturbance. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05442957?
The interventions under investigation include: Attention Control (BEHAVIORAL), BRIGHT (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05442957?
This trial is sponsored by Medical University of South Carolina, which has 643 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05442957 being conducted?
This trial has 5 study locations across Michigan, Missouri, Pennsylvania, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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